Commonwealth Consolidated Regulations Commonwealth Consolidated Regulations(regulation 3.4)
Part 1 -- Full quality assurance procedures
The conformity assessment procedures set out in this Part provide for the manufacturer of a kind of medical device:
(a) to:
(i) implement a quality management system for the design, production, packaging, labelling and final inspection of the kind of device; and
(ii) arrange for assessment of the system by the Secretary or an Australian conformity assessment body; and
(b) for a Class 4 IVD medical device, Class 4 in - house IVD medical device or Class III medical device--to arrange for examination of the design of the kind of device by the Secretary or an Australian conformity assessment body; and
(c) to allow the Secretary or an Australian conformity assessment body to monitor the operation of, and carry out inspections of, the system; and
(d) to make a declaration of conformity in relation to the kind of device; and
(e) to:
(i) notify the Secretary or an Australian conformity assessment body of any change to the system, or to the kinds of devices to which the system is to be applied; and
(ii) arrange for assessment of any such change by the Secretary or an Australian conformity assessment body; and
(f) to establish and keep up - to - date a post - market monitoring, reporting and corrective action system.
Note: See Division 3.2 in relation to the kinds of medical devices to which these conformity assessment procedures may be applied.
1.2 References to kinds of medical devices
A reference in this Part to a kind of medical device includes a reference to an individual medical device.
1.3 Implementation and assessment of quality management system
(1) The manufacturer of a kind of medical device must:
(a) implement a quality management system for the design, production, packaging, labelling and final inspection of the kind of device; and
(b) arrange for assessment of the system by the Secretary or an Australian conformity assessment body.
(2) For the purpose of enabling the assessment to be carried out, the manufacturer must have available, in writing, the following information and undertakings:
(a) the name and business address of the manufacturer;
(b) details of each manufacturing site where the system is to be applied;
(c) all relevant information about the kind of medical devices to which the system is to be applied;
(d) the documentation in relation to the system;
(e) an undertaking by the manufacturer to continue to comply with the requirements of the system after assessment;
(f) an undertaking by the manufacturer to ensure that the system is at all times adequate and efficacious;
(g) an undertaking by the manufacturer:
(i) if the manufacturer arranged for assessment of the system by the Secretary--to notify the Secretary, or the person in relation to whom the kind of device is included in the Register, of any information of the kind mentioned in paragraph 1.4(3A)(a) or (b) that the manufacturer becomes aware of in relation to the kind of medical device; or
(ii) if the manufacturer arranged for assessment of the system by an Australian conformity assessment body--to notify the body, or the person in relation to whom the kind of device is included in the Register, of any information of the kind mentioned in paragraph 1.4(3A)(a) or (b) that the manufacturer becomes aware of in relation to the kind of medical device.
1.4 Requirements of quality management system
(1) A quality management system that is to be assessed under clause 1.3 must meet the requirements of this clause.
(2) The system must be of a kind such that its application will ensure that each medical device to which the system is applied complies with the applicable provisions of the essential principles, the classification rules, and these conformity assessment procedures, at each stage, from the design of the device until its final inspection before being supplied.
(3) The system must include post - marketing requirements under which the manufacturer of a medical device to which the system is applied is required:
(a) to systematically review experience gained, post - production, in relation to medical devices of that kind; and
(b) to implement appropriate means to apply any necessary corrective action in relation to the design or production of such devices; and
(c) to:
(i) if the manufacturer arranged for assessment of the system under clause 1.3 by the Secretary--notify the Secretary, or the person in relation to whom the kind of device is included in the Register, as soon as practicable after becoming aware of information referred to in subclause (3A); or
(ii) if the manufacturer arranged for assessment of the system under clause 1.3 by an Australian conformity assessment body--notify the body, or the person in relation to whom the kind of device is included in the Register, as soon as practicable after becoming aware of information referred to in subclause (3A).
Note: See also paragraph 41FN(3)(d) and sections 41MP and 41MPA of the Act in relation to the requirement to give certain information about a medical device to the Secretary.
(3A) For the purposes of subparagraphs (3)(c)(i) and (ii), the information is the following:
(a) information relating to:
(i) any malfunction or deterioration in the characteristics or performance of the kind of device; or
(ii) any inadequacy in the design, production, labelling or instructions for use of the kind of device, or in the advertising material for the kind of device; or
(iii) any use in accordance with, or contrary to, the use intended by the manufacturer of the kind of device;
that might lead, or might have led, to the death of a patient or a user of the device, or to a serious deterioration in his or her state of health;
(b) information relating to any technical or medical reason for a malfunction or deterioration of a kind mentioned in subparagraph (a)(i) that has led the manufacturer to take steps to recall devices of that kind that have been distributed.
(4) Each requirement of the system must be documented in a systematic and orderly way in the form of written policies and procedures (for example, as quality programs, quality plans, quality manuals or quality records).
(5) The documentation of the system must include adequate information in relation to the following matters:
(a) the manufacturer's quality objectives;
(b) the organisation of the manufacturer's business, including, in particular, a description of the following:
(i) the organisational structure of the business;
(ii) the responsibilities of managerial staff and their authority in relation to the quality of the design and production of medical devices manufactured by the manufacturer;
(iii) the methods of monitoring whether the system is operating effectively, in particular, whether the desired quality of design and product is being achieved and how products that fail to meet the desired quality are controlled;
(c) the design of the kind of medical device to which the system is to be applied, including, in particular, the following:
(i) details of the processes, systems and measures used for controlling, monitoring and verifying that at each stage of the design process, the device complies with the applicable provisions of the essential principles;
(ii) a general description of the kind of device, and of any variants of the kind of device, that the manufacturer plans to manufacture;
(iii) details of the design specifications for the kind of device, including:
(A) any medical device standard or conformity assessment standard that has been applied to the device; and
(B) the results of the risk analysis carried out; and
(C) if no medical device standard or conformity assessment standard, or part only of such a standard, has been applied to the device--the solutions adopted to ensure that each device complies with the applicable provisions of the essential principles;
(iv) for a kind of device that is intended by the manufacturer to be connected to another device--evidence demonstrating that the device will comply with the applicable provisions of the essential principles when it is connected to the other device and both devices are being used for their intended purposes;
(v) a statement indicating whether or not the kind of device incorporates, or is intended to incorporate, as an integral part, a substance mentioned in clause 7.4 of the essential principles, and, for a device that will do so, data derived from tests conducted in relation to the device and the substance, and their interaction;
(vi) a statement indicating whether or not the device, other than an IVD medical device, contains tissues, cells or substances of animal origin that have been rendered non - viable, or tissues, cells or substances of microbial or recombinant origin;
(via) for an IVD medical device--a statement indicating whether or not the device contains viable tissues, cells, or substances of human or animal origin;
(vii) a copy of the clinical evidence, in relation to the kind of device, required by the clinical evaluation procedures;
(viii) a copy of the information to be provided with the kind of device;
(d) the inspection and quality assurance techniques to be applied in the production of the kind of medical device to which the system is to be applied, including, in particular, information about the following:
(i) the processes and procedures to be used (particularly in relation to sterilisation) and the documents relating to those processes and procedures;
(ii) the procedures to be used for purchasing goods or services in relation to the production of the kind of device and the documents relating to those procedures;
(iii) product identification procedures to be prepared and kept up - to - date from drawings, specifications or other documents at each stage of production;
(e) the tests or trials to be carried out before, during and after production of the kind of medical device to which the system is to be applied, including, in particular, information about:
(i) the frequency with which the tests or trials are to be carried out; and
(ii) the equipment (including the traceability of the calibration of the equipment) used, or to be used, to carry out the tests or trials;
(f) the system for reviewing experience gained in the post - production phase in relation to the kind of medical device to which the quality management system has been applied, and the means by which any necessary corrective action will be applied in relation to the design or production of such devices;
(g) whether a conformity assessment standard has been applied to the system and, if no conformity assessment standard, or part only of a conformity assessment standard, has been applied to the system--the solutions adopted to ensure that the system complies with subclause (2).
1.5 Changes to quality management system or kinds of medical device to which system is to be applied
(1) This clause applies to the manufacturer of a kind of medical device if:
(a) the manufacturer has implemented, and had assessed under clause 1.3 of this Schedule, a quality management system that is to be applied to the kind of device; and
(b) after assessment, the manufacturer plans to make:
(i) a substantial change to the system; or
(ii) a change to the kinds of medical devices to which the system is to be applied.
(2) The manufacturer must:
(a) notify the Secretary or an Australian conformity assessment body, in writing, of the proposed change; and
(b) arrange for assessment of the change by the Secretary or the Australian conformity assessment body to verify whether the system, as changed, meets the requirements of clause 1.4 of this Schedule.
(3) For the purpose of enabling the assessment to be carried out, the manufacturer must have available, in writing, details of any consequential changes to the information and documentation required under subclause 1.3(2) of this Schedule in relation to the system or kinds of devices.
(4) After any change to the quality management system, the manufacturer must ensure that the changed system continues to meet the requirements of clause 1.4 of this Schedule.
(1) This clause applies to the manufacturer of a Class 4 IVD medical device, a Class 4 in - house IVD medical device or a Class III medical device, to which the quality management system that is to be assessed under clause 1.3 is to be applied.
(2) For the purpose of assessing whether the kind of medical device complies with the applicable provisions of the essential principles, the manufacturer of the device must arrange for examination by the Secretary or an Australian conformity assessment body of the design of the kind of device.
(3) For the purpose of enabling the examination to be carried out, the manufacturer must have available:
(a) information, in writing, in relation to the following matters in relation to the kind of medical device:
(i) the design;
(ii) the production process;
(iii) the intended performance; and
(b) a copy of the documentation mentioned in paragraph 1.4(5)(c) of this Schedule necessary to assess whether the kind of medical device complies with the applicable provisions of the essential principles.
(4) If, after examination by the Secretary or an Australian conformity assessment body of the design of a kind of medical device, the manufacturer makes a substantial change to the design, or the intended performance, of the kind of device, the manufacturer must:
(a) notify the Secretary or an Australian conformity assessment body, in writing, of the change; and
(b) arrange for examination of the change by the Secretary or the Australian conformity assessment body to assess whether the design, or the intended performance, of the medical device, as changed, complies with the applicable provisions of the essential principles.
(5) For the purpose of enabling an examination to be carried out under subclause (4), the manufacturer must have available, in writing, details of any consequential changes to the documentation in relation to the design of the device mentioned in paragraph 1.4(5)(c) of this Schedule.
Note: This clause need not be applied to:
(a) a Class IIb medical device--see Division 3.2, paragraphs 3.7(1)(a) and (2)(a); or
(b) a Class 3 IVD medical device--see Division 3.2, paragraph 3.7A(a); or
(c) a Class IIa medical device--see Division 3.2, paragraphs 3.8(1)(a) and (2)(a); or
(d) a Class 2 IVD medical device--see Division 3.2, paragraph 3.8A(a).
1.7 Information to be given to authorised person
(1) If requested to do so by an authorised person, the manufacturer of a kind of medical device must:
(a) give to the Secretary the following information in relation to the quality management system or the kinds of medical device to which the system is applied:
(i) a copy of the documentation mentioned in subclause 1.4(5) of this Schedule;
(ii) data in relation to the design of the kinds of medical device (for example, the results of any analysis of the device, calculations, tests);
(iii) data in relation to the manufacture of the kinds of medical device (for example, inspection reports, test data, calibration data, information about the qualifications of staff); and
(b) arrange for tests specified by the authorised person to be carried out for the purpose of checking whether the quality management system is operating effectively.
(2) If any inspections or tests are carried out by an authorised person in relation to the manufacturer's premises, or medical devices produced by the manufacturer, the manufacturer may ask the authorised person to give to the manufacturer a report stating the findings of the inspections or tests.
(1) The manufacturer of a kind of medical device to which a quality management system that has been assessed under clause 1.3 of this Schedule has been applied must make a declaration of conformity in relation to the kind of device.
(2) The declaration must:
(a) state that the declaration is a declaration of conformity made under clause 1.8 of Schedule 3 to the Therapeutic Goods (Medical Devices) Regulations 2002 ; and
(b) state the name and business address of the manufacturer of the device; and
(c) state the following information in relation to each kind of medical device to which the system has been applied:
(i) the unique product identifier;
(ii) the medical device classification;
(iii) the device nomenclature system code; and
(d) if the system has not been applied to all medical devices of that kind manufactured by the manufacturer--give details of the medical devices to which the system has been applied (for example, by reference to lot numbers, batches or serial numbers, or by specifying the kinds of medical devices or the times of manufacture); and
(e) state that each kind of medical device to which the system has been applied complies with the applicable provisions of the essential principles, the classification rules, and the full quality assurance procedures, at each stage, from the design of the device until its final inspection before being supplied; and
(f) state the identification number of the conformity assessment certificate, or of the Australian conformity assessment body certificate, issued in relation to the system or the kind of medical devices to which the system has been applied; and
(g) give details of any conformity assessment standard or medical device standard that has been applied to a kind of device to which the system has been applied; and
(h) be signed by a person authorised by the manufacturer; and
(i) set out the name and position of the person signing the declaration; and
(j) state the date when the declaration is signed.
(1) The manufacturer of a kind of medical device to which a quality management system that has been assessed under clause 1.3 of this Schedule has been applied must keep the following records in relation to the system and the kind of device:
(a) the documentation mentioned in subclause 1.4(5) of this Schedule;
(b) details of any changes made to the system and to the information and documentation required under subclause 1.3(2) of this Schedule;
(c) if the device is a Class 4 IVD medical device, Class 4 in - house IVD medical device or Class III medical device, the information and documentation required under subclause 1.6(3) of this Schedule;
(d) details of any changes made to the kind of medical device and to the documentation in relation to the design of the device mentioned in paragraph 1.4(5)(c) of this Schedule;
(e) the declaration of conformity under clause 1.8 of this Schedule;
(f) details of the systematic review carried out, post - production, in relation to medical devices of that kind;
(g) any notice, report, certificate or other document in relation to the system issued to the manufacturer by the Secretary or an Australian conformity assessment body.
(2) The manufacturer must keep the records for at least 5 years after the manufacture of the last medical device to which the quality management system was applied.
(3) On request from the Secretary, the manufacturer must make the records available to the Secretary.
Part 2 -- Type examination procedures
The conformity assessment procedures set out in this Part provide for the manufacturer to arrange for examination by the Secretary or an Australian conformity assessment body of a representative sample of a kind of medical device (the type ).
Note: See Division 3.2 in relation to the kinds of medical devices to which these conformity assessment procedures may be applied.
2.2 References to kinds of medical devices
A reference in this Part to a kind of medical device includes a reference to an individual medical device.
(1) The manufacturer of a medical device must arrange for examination of the type by the Secretary or an Australian conformity assessment body.
(2) For the purpose of enabling the examination to be carried out, the manufacturer must have available, in writing, the following information:
(a) the name and business address of the manufacturer;
(b) the documentation mentioned in subclause (3) in relation to the type.
(3) For paragraph (2)(b), the documentation must include adequate information about the design, production process and intended performance of the type, and must include, in particular, the following:
(a) a general description of the type, and of any variants of the type that the manufacturer plans to manufacture;
(b) diagrams or drawings of the design of the type, including diagrams or drawings of any components, sub - assemblies or circuits of the type;
(c) any descriptions or explanations that are necessary to enable the diagrams or drawings mentioned in paragraph (b), or the intended operation of the type, to be properly understood;
(d) the proposed method or methods of manufacture of the type;
(e) if the type is intended by the manufacturer to be supplied in a sterile state--a description of the method used to sterilise the type;
(f) details of each medical device standard or conformity assessment standard that has been applied, wholly or in part, to the type;
(g) if no medical device standard or conformity assessment standard has been applied, or such a standard has been only partly applied, to the type--descriptions of the solutions adopted to ensure that the type complies with the applicable provisions of the essential principles;
(h) the results of any design calculations, risk analyses, investigations, technical tests, or any other tests, carried out in relation to the type;
(i) a statement indicating whether or not the type incorporates, or is intended to incorporate, as an integral part, a substance mentioned in clause 7.4 of the essential principles, and, for a type that does so, data derived from tests conducted in relation to the type and the substance, and their interaction;
(j) a statement indicating whether or not the device, other than an IVD medical device, contains tissues, cells or substances of animal origin that have been rendered non - viable, or tissues, cells or substances of microbial or recombinant origin;
(ja) for an IVD medical device--a statement indicating whether or not the device contains viable tissues, cells, or substances of human or animal origin;
(k) a copy of the clinical evidence, in relation to the kind of device, required by the clinical evaluation procedures;
(l) a copy of the information to be provided with the type.
(4) The manufacturer must make available to the Secretary or the Australian conformity assessment body for examination:
(a) a sample of the type; and
(b) on request from the Secretary or the Australian conformity assessment body, additional samples of the type.
(5) If the type is intended by the manufacturer to be connected to another medical device, the manufacturer must, on request from the Secretary or the Australian conformity assessment body, make available to the Secretary or the Australian conformity assessment body, or arrange for the Secretary or the Australian conformity assessment body to have access to, a sample of the device.
2.4 Changes to design of medical device after examination
(1) This clause applies if, after examination by the Secretary or an Australian conformity assessment body of a type, the manufacturer of the type plans to make a substantial change to the design, or intended performance, of the kind of medical device to which the type relates.
(2) The manufacturer must:
(a) notify the Secretary or an Australian conformity assessment body, in writing, of the proposed change; and
(b) arrange for examination of the change by the Secretary or the Australian conformity assessment body to verify whether the type, as changed, meets the requirements of clause 2.3 of this Schedule.
(3) For the purpose of enabling the examination to be carried out, the manufacturer must have available, in writing, details of any consequential changes to the documentation required under subclause 2.3(3) of this Schedule in relation to the type.
(1) The manufacturer of the type that has been examined under this Part must keep the following records:
(a) the documentation required under subclause 2.3(3) of this Schedule in relation to the type;
(b) details of any changes made to the type and to the documentation required under subclause 2.3(3) of this Schedule;
(c) any notice, report, certificate or other document in relation to the type issued to the manufacturer by the Secretary or an Australian conformity assessment body.
(2) The manufacturer must keep the records for at least 5 years after the manufacture of the last medical device of that type.
(3) On request from the Secretary, the manufacturer must make the records available to the Secretary.
Part 3 -- Verification procedures
The conformity assessment procedures set out in this Part provide for the manufacturer of a kind of medical device:
(a) to arrange for examination and testing of the kind of device by the Secretary or an Australian conformity assessment body; and
(b) to make a declaration of conformity in relation to the kind of device; and
(c) to establish and keep up - to - date a post - market monitoring, reporting and corrective action system.
Note: See Division 3.2 in relation to the kinds of medical devices to which these conformity assessment procedures may be applied.
3.2 References to kinds of medical devices
A reference in this Part to a kind of medical device includes a reference to an individual medical device.
3.3 Verification of conformity
(1) The manufacturer of a medical device must arrange for examination and testing by the Secretary or an Australian conformity assessment body of each device of that kind, or a representative sample from a batch of medical devices of that kind, to verify that:
(a) for a kind of device in relation to which the type examination procedures have been applied--each device, or representative sample, conforms to the approved type; and
(b) for a kind of device to which the declaration of conformity (not requiring assessment by Secretary) procedures have been applied--each device, or representative sample, is in accordance with the technical documentation prepared under clause 6.4 of those procedures for that kind of device; and
(c) each device, or representative sample, complies with the applicable provisions of the essential principles, the classification rules and these conformity assessment procedures.
(2) For the purpose of enabling the examination and testing to be carried out, the manufacturer must have available, in writing, the following information and undertakings:
(a) the name and business address of the manufacturer;
(b) the documentation describing the manufacturing process to be used to manufacture the kind of device;
(c) a description of the procedures that have been, or will be, implemented to ensure that all devices of that kind manufactured by the manufacturer will be uniform;
(d) an undertaking to implement those procedures to ensure that all devices of that kind manufactured by the manufacturer will be uniform;
(e) an undertaking by the manufacturer:
(i) if the manufacturer arranged for examination and testing by the Secretary--to notify the Secretary, or the person in relation to whom the kind of device is included in the Register, of any information of the kind mentioned in paragraph 3.4(2A)(a) or (b) that the manufacturer becomes aware of in relation to the kind of medical device; or
(ii) if the manufacturer arranged for examination and testing by an Australian conformity assessment body--to notify the body, or the person in relation to whom the kind of device is included in the Register, of any information of the kind mentioned in paragraph 3.4(2A)(a) or (b) that the manufacturer becomes aware of in relation to the kind of medical device;
(f) for a kind of device in relation to which the type examination procedures have been applied--evidence that the device conforms to the approved type and a copy of the technical documentation required under subclause 2.3(3) of the type examination procedures for the approved type;
(g) for a kind of device to which the declaration of conformity (not requiring assessment by Secretary) procedures have been applied--a copy of the technical documentation prepared under clause 6.4 of those procedures for that kind of device.
(3) The manufacturer must make available to the Secretary or the Australian conformity assessment body for examination and testing:
(a) for a kind of device in relation to which the type examination procedures have been applied:
(i) each medical device that is to be verified in relation to the approved type; or
(ii) each medical device selected by the Secretary or the Australian conformity assessment body on a statistical basis from a uniform batch of devices that are to be verified in relation to the approved type; and
(b) for a kind of device to which the declaration of conformity (not requiring assessment by Secretary) procedures have been applied:
(i) each medical device of that kind to which those procedures have been applied; or
(ii) each medical device selected by the Secretary or the Australian conformity assessment body on a statistical basis from a uniform batch of devices of that kind to which those procedures have been applied.
3.4 Requirements of manufacturing system
(1) The manufacturer of a medical device must ensure that:
(a) for a kind of device in relation to which the type examination procedures have been applied--the process used to manufacture the device results in the device conforming to the approved type; and
(b) for a kind of device to which the declaration of conformity (not requiring assessment by Secretary) procedures have been applied--the process used to manufacture the device results in the device being in accordance with the technical documentation prepared under clause 6.4 of those procedures for that kind of device.
(2) The manufacturer of a medical device of a kind mentioned in subclause (1) must ensure that the process used to manufacture the device includes post - marketing requirements under which the manufacturer is required:
(a) to systematically review experience gained in the post - production phase in relation to medical devices of that kind; and
(b) to implement appropriate means to apply any necessary corrective action in relation to the design or production of such devices; and
(c) to:
(i) if the manufacturer arranged for examination and testing under clause 3.3 by the Secretary--notify the Secretary, or the person in relation to whom the kind of device is included in the Register, as soon as practicable after becoming aware of information referred to in subclause (2A); or
(ii) if the manufacturer arranged for examination and testing under clause 3.3 by an Australian conformity assessment body--notify the body, or the person in relation to whom the kind of device is included in the Register, as soon as practicable after becoming aware of information referred to in subclause (2A).
Note: See also paragraph 41FN(3)(d) and sections 41MP and 41MPA of the Act in relation to the requirement to give certain information about a medical device to the Secretary.
(2A) For the purposes of subparagraphs (2)(c)(i) and (ii), the information is the following:
(a) information relating to:
(i) any malfunction or deterioration in the characteristics or performance of the kind of device; or
(ii) any inadequacy in the design, production, labelling, instructions for use or advertising materials of the kind of device; or
(iii) any use in accordance with, or contrary to, the use intended by the manufacturer of the kind of device;
that might lead, or might have led, to the death of a patient or a user of the device, or to a serious deterioration in his or her state of health;
(b) information relating to any technical or medical reason for a malfunction or deterioration of a kind mentioned in subparagraph (a)(i) that has led the manufacturer to take steps to recall devices of that kind that have been distributed.
(3) Before manufacturing a medical device of a kind mentioned in subclause (1), the manufacturer must prepare documentation describing the manufacturing process to be used to produce the device.
(4) Without limiting subclause (3), the documentation must include a description of the procedures that have been, or will be, implemented to ensure that all devices of that kind manufactured by the manufacturer will be uniform.
(1) The manufacturer of a Class III medical device or Class IIb medical device that has been verified under this Part must make a declaration of conformity in relation to the kind of device.
Note: This clause need not be applied to the following kinds of medical devices if the declaration of conformity (not requiring assessment by Secretary) procedures have been applied to the device:
(a) a Class IIa medical device (see Division 3.2, subparagraph 3.8(1)(b)(i));
(b) a Class I medical device that has a measuring function (see Division 3.2, paragraph 3.9(3)(a)).
(2) The declaration must:
(a) state that the declaration is a declaration of conformity made under clause 3.5 of Schedule 3 to the Therapeutic Goods (Medical Devices) Regulations 2002 ; and
(b) state the name and business address of the manufacturer of the device; and
(c) state the following information in relation to each device that has been verified:
(i) the unique product identifier;
(ii) the medical device classification;
(iii) the device nomenclature system code; and
(d) if the verification does not relate to all medical devices of that kind manufactured by the manufacturer--give details of the medical devices to which the verification relates (for example, by reference to lot numbers, batches or serial numbers, or by specifying the kinds of medical devices or the times of manufacture); and
(e) for a kind of device in relation to which the type examination procedures have been applied:
(i) state the identification number of the conformity assessment certificate, or of the Australian conformity assessment body certificate, issued in relation to the approved type; and
(ii) state that the kind of device conforms to the approved type; and
(f) state that each kind of medical device or batch of devices complies with the applicable provisions of the essential principles and the classification rules;
(g) state the basis on which the declaration is made; and
(h) give details of any conformity assessment standard or medical device standard that has been applied to the kind of device or the processes used to manufacture the device; and
(i) be signed by a person authorised by the manufacturer; and
(j) set out the name and position of the person signing the declaration; and
(k) state the date when the declaration is signed.
(1) The manufacturer of a kind of medical device that has been verified under this Part must keep the following records:
(a) the documentation mentioned in subclause 3.4(3) of this Schedule;
(b) for a Class III medical device or Class IIb medical device--the declaration of conformity under clause 3.5 of this Schedule;
(c) any notice, report, certificate or other document in relation to the device, or a batch of devices that includes the device, issued to the manufacturer by the Secretary or an Australian conformity assessment body.
(2) The manufacturer must keep the records for at least 5 years after the manufacture of the last medical device to which the verification relates.
(3) On request from the Secretary, the manufacturer must make the records available to the Secretary.
Part 4 -- Production quality assurance procedures
The conformity assessment procedures set out in this Part provide for the manufacturer of a kind of medical device:
(a) to:
(i) implement a quality management system for the production and final inspection of the kind of device; and
(ii) arrange for assessment of the system by the Secretary or an Australian conformity assessment body; and
(b) to allow the Secretary or an Australian conformity assessment body to monitor the operation of, and carry out inspections of, the system; and
(c) to make a declaration of conformity in relation to the kind of device; and
(d) to:
(i) notify the Secretary or an Australian conformity assessment body of any change to the system; and
(ii) arrange for assessment of any such change by the Secretary or an Australian conformity assessment body; and
(e) to establish and keep up - to - date a post - market monitoring, reporting and corrective action system.
Note: See Division 3.2 in relation to the kinds of medical devices to which these conformity assessment procedures may be applied.
4.2 References to kinds of medical devices
A reference in this Part to a kind of medical device includes a reference to an individual medical device.
4.3 Implementation and assessment of production quality management system
(1) The manufacturer of a medical device must:
(a) implement a quality management system for the production and final inspection of the kind of device; and
(b) arrange for assessment of the system by the Secretary or an Australian conformity assessment body.
(2) For the purpose of enabling the assessment to be carried out, the manufacturer must have available, in writing, the following information and undertakings:
(a) the name and business address of the manufacturer;
(b) details of each manufacturing site where the system is to be applied;
(c) all relevant information about the kinds of medical devices to which the system is to be applied;
(d) the documentation in relation to the system;
(e) an undertaking by the manufacturer to continue to comply with the requirements of the system after assessment;
(f) an undertaking by the manufacturer to ensure that the system is at all times adequate and efficacious;
(g) for a kind of device in relation to which the type examination procedures have been applied--evidence that the device conforms to the approved type and a copy of the technical documentation required under subclause 2.3(3) of the type examination procedures for the approved type;
(h) for a kind of device to which the declaration of conformity (not requiring assessment by Secretary) procedures have been applied--a copy of the technical documentation prepared under clause 6.4 of those procedures for that kind of device;
(i) an undertaking by the manufacturer:
(i) if the manufacturer arranged for assessment of the system by the Secretary--to notify the Secretary, or the person in relation to whom the kind of device is included in the Register, of any information of the kind mentioned in paragraph 4.4(3A)(a) or (b) that the manufacturer becomes aware of in relation to the kind of medical device; or
(ii) if the manufacturer arranged for assessment of the system by an Australian conformity assessment body--to notify the body, or the person in relation to whom the kind of device is included in the Register, of any information of the kind mentioned in paragraph 4.4(3A)(a) or (b) that the manufacturer becomes aware of in relation to the kind of medical device.
4.4 Requirements of production quality management system
(1) A quality management system that is to be assessed under clause 4.3 must meet the requirements of this clause.
(2) The system must be of a kind such that its application will ensure that:
(a) each medical device to which the system is applied that is of a kind in relation to which the type examination procedures have been applied conforms to the approved type; and
(b) each medical device to which the system is applied that is of a kind to which the declaration of conformity (not requiring assessment by Secretary) procedures are applied is in accordance with the technical documentation prepared under clause 6.4 of those procedures for the device.
(3) The system must include post - marketing requirements under which the manufacturer of a medical device to which the system is applied is required:
(a) to systematically review experience gained in the post - production phase in relation to medical devices of that kind; and
(b) to implement appropriate means to apply any necessary corrective action in relation to the design or production of such devices; and
(c) to:
(i) if the manufacturer arranged for assessment of the system under clause 4.3 by the Secretary--notify the Secretary, or the person in relation to whom the kind of device is included in the Register, as soon as practicable after becoming aware of information referred to in subclause (3A); or
(ii) if the manufacturer arranged for assessment of the system under clause 4.3 by an Australian conformity assessment body--notify the body, or the person in relation to whom the kind of device is included in the Register, as soon as practicable after becoming aware of information referred to in subclause (3A).
Note: See also paragraph 41FN(3)(d) and sections 41MP and 41MPA of the Act in relation to the requirement to give certain information about a medical device to the Secretary.
(3A) For the purposes of subparagraphs (3)(c)(i) and (ii), the information is the following:
(a) information relating to:
(i) any malfunction or deterioration in the characteristics or performance of the kind of device; or
(ii) any inadequacy in the design, production, labelling, instructions for use or advertising materials of the kind of device; or
(iii) any use in accordance with, or contrary to, the use intended by the manufacturer of the kind of device;
that might lead, or might have led, to the death of a patient or a user of the device, or to a serious deterioration in his or her state of health;
(b) information relating to any technical or medical reason for a malfunction or deterioration of a kind mentioned in subparagraph (a)(i) that has led the manufacturer to take steps to recall devices of that kind that have been distributed.
(4) Each requirement of the system must be documented in a systematic and orderly way in the form of written policies and procedures (for example, as quality programs, quality plans, quality manuals or quality records).
(5) The documentation of the system must include adequate information in relation to the following matters:
(a) the manufacturer's quality objectives;
(b) the organisation of the manufacturer's business, including, in particular, a description of the following:
(i) the organisational structure of the business;
(ii) the responsibilities of managerial staff and their authority in relation to the production of the medical devices produced by the manufacturer;
(iii) the methods of monitoring whether the system is operating effectively, in particular, whether the desired quality of product is being achieved and how products that fail to meet the desired quality are controlled;
(c) the inspection and quality assurance techniques applied in the manufacturing process, including, in particular, information about the following:
(i) the processes and procedures to be used (particularly in relation to sterilisation) and the documents relating to those procedures;
(ii) the procedures to be used for purchasing goods or services in relation to the production of the kind of device produced and the documents relating to those procedures;
(iii) product identification procedures to be prepared and kept up - to - date from drawings, specifications or other documents at each stage of manufacture;
(d) the tests or trials to be carried out before, during and after production of the kind of medical device to which the system is to be applied, including, in particular, information about:
(i) the frequency with which the tests or trials are to be carried out; and
(ii) the equipment (including the traceability of the calibration of the equipment) used, or to be used, to carry out the tests or trials;
(e) the system for reviewing experience gained in the post - production phase in relation to the kind of medical device to which the quality management system has been applied, and the means by which any necessary corrective action will be applied in relation to the design or production of such devices;
(f) whether a conformity assessment standard has been applied to the system and, if no conformity assessment standard, or part only of a conformity assessment standard, has been applied to the system--the solutions adopted to ensure that the system complies with subclause (2).
4.5 Changes to production quality management system
(1) This clause applies to the manufacturer of a medical device if:
(a) the manufacturer has implemented, and had assessed under clause 4.3 of this Schedule, a quality management system that is to be applied to the device; and
(b) after assessment, the manufacturer plans to make a substantial change to the system.
(2) The manufacturer must:
(a) notify the Secretary or an Australian conformity assessment body, in writing, of the proposed change; and
(b) arrange for assessment of the change by the Secretary or the Australian conformity assessment body to verify whether the system, as changed, meets the requirements of clause 4.4 of this Schedule.
(3) For the purpose of enabling the assessment to be carried out, the manufacturer must have available, in writing, details of any consequential changes to the information and documentation required under subclause 4.3(2) of this Schedule in relation to the system.
(4) After any change to the quality management system, the manufacturer must ensure that the changed system continues to meet the requirements of clause 4.4 of this Schedule.
4.6 Information to be given to authorised person
(1) If requested to do so by an authorised person, the manufacturer of a medical device must:
(a) give to the Secretary the following information in relation to the quality management system or the kinds of medical device to which the system is applied:
(i) a copy of the documentation mentioned in subclause 4.4(5) of this Schedule;
(ii) data in relation to the production of the kinds of medical device (for example, inspection reports, test data, calibration data, information about the qualifications of staff); and
(b) arrange for tests specified by the authorised person to be carried out for the purpose of checking whether the quality management system is operating effectively.
(2) If any inspections or tests are carried out by an authorised person under this clause, the manufacturer may ask the authorised person to give to the manufacturer a report stating the findings of the inspections or tests.
(1) The manufacturer of a Class 4 IVD medical device, Class 3 IVD medical device, Class III medical device or Class IIb medical device to which a quality management system that has been assessed under clause 4.3 of this Schedule has been applied must make a declaration of conformity in relation to the kind of device.
Note: This clause need not be applied to the following kinds of medical devices, if the declaration of conformity (not requiring assessment by Secretary) procedures have been applied to the device:
(a) a Class IIa medical device--see Division 3.2, subparagraph 3.8(1)(b)(ii);
(b) a Class 2 IVD medical device--see Division 3.2, paragraph 3.8A(b);
(c) a Class I medical device that the manufacturer intends to be supplied in a sterile state--see Division 3.2, subclause 3.9(2);
(d) a Class I medical device that has a measuring function--see Division 3.2, paragraph 3.9(3)(b).
(2) The declaration must:
(a) state that the declaration is a declaration of conformity made under clause 4.7 of Schedule 3 to the Therapeutic Goods (Medical Devices) Regulations 2002 ; and
(b) state the name and business address of the manufacturer of the device; and
(c) state the following information in relation to each kind of medical device to which the system has been applied:
(i) the medical device classification;
(ii) the device nomenclature system code; and
(d) if the system has not been applied to all medical devices of that kind manufactured by the manufacturer--give details of the medical devices to which the system has been applied (for example, by reference to lot numbers, batches or serial numbers, or by specifying the kinds of medical devices or the times of manufacture); and
(e) for a kind of device in relation to which the type examination procedures have been applied--state that:
(i) the type examination procedures have been applied to the kind of device; and
(ii) the kind of device conforms to the approved type; and
(f) state the identification number of the conformity assessment certificate, or of the Australian conformity assessment body certificate, issued in relation to the system or the kind of medical devices to which the system has been applied; and
(g) state that each kind of medical device to which the system has been applied complies with the applicable provisions of the essential principles, the classification rules and the production quality assurance procedures before being supplied; and
(h) give details of any conformity assessment standard that has been applied to the system; and
(i) be signed by a person authorised by the manufacturer; and
(j) set out the name and position of the person signing the declaration; and
(k) state the date when the declaration is signed.
(1) The manufacturer of a kind of medical device to which a quality management system that has been assessed under clause 4.3 of this Schedule has been applied must keep the following records in relation to the system and the kind of device:
(a) the documentation mentioned in subclause 4.4(5) of this Schedule;
(b) details of any changes made to the system and to the information and documentation required under subclause 4.5(3) of this Schedule;
(c) for a Class 4 IVD medical device, Class 3 IVD medical device, Class III medical device or Class IIb medical device--the declaration of conformity under clause 4.7 of this Schedule;
(d) any notice, report, certificate or other document in relation to the system issued to the manufacturer by the Secretary or an Australian conformity assessment body.
(2) The manufacturer must keep the records for at least 5 years after the manufacture of the last medical device to which the quality management system was applied.
(3) On request from the Secretary, the manufacturer must make the records available to the Secretary.
Part 5 -- Product quality assurance procedures
The conformity assessment procedures set out in this Part provide for the manufacturer of a kind of medical device:
(a) to:
(i) implement a product quality management system for the final inspection and testing of the kind of device; and
(ii) arrange for assessment of the system by the Secretary or an Australian conformity assessment body; and
(b) to allow the Secretary or an Australian conformity assessment body to monitor the operation of, and carry out inspections of, the system; and
(c) to make a declaration of conformity in relation to the kind of device; and
(d) to:
(i) notify the Secretary or an Australian conformity assessment body of any change to the system, or to the kinds of devices to which the system is to be applied; and
(ii) arrange for assessment of any such change by the Secretary or an Australian conformity assessment body; and
(e) to establish and keep up - to - date a post - market monitoring, reporting and corrective action system.
Note: See Division 3.2 in relation to the kinds of medical devices to which these conformity assessment procedures may be applied.
5.2 References to kinds of medical devices
A reference in this Part to a kind of medical device includes a reference to an individual medical device.
5.3 Implementation and assessment of product quality management system
(1) The manufacturer of a medical device must:
(a) implement a product quality management system for the final inspection and testing of the kind of device; and
(b) arrange for assessment of the system by the Secretary or an Australian conformity assessment body.
(2) For the purpose of enabling the assessment to be carried out, the manufacturer must have available, in writing, the following information and undertakings:
(a) the name and business address of the manufacturer;
(b) details of each manufacturing site where the system is to be applied;
(c) all relevant information about the kinds of medical devices to which the system is to be applied;
(d) the documentation in relation to the system;
(e) an undertaking by the manufacturer to continue to comply with the requirements of the system after assessment;
(f) an undertaking by the manufacturer to ensure that the system is at all times adequate and efficacious;
(g) for a kind of device in relation to which the type examination procedures have been applied--evidence that the device conforms to the approved type and the technical documentation required under subclause 2.3(3) of the type examination procedures for the device;
(h) for a kind of device to which the declaration of conformity (not requiring assessment by Secretary) procedures have been applied--a copy of the technical documentation prepared under clause 6.4 of those procedures for that kind of device;
(i) an undertaking by the manufacturer:
(i) if the manufacturer arranged for assessment of the system by the Secretary--to notify the Secretary, or the person in relation to whom the kind of device is included in the Register, of any information of the kind mentioned in paragraph 5.4(3A)(a) or (b) that the manufacturer becomes aware of in relation to the kind of medical device; or
(ii) if the manufacturer arranged for assessment of the system by an Australian conformity assessment body--to notify the body, or the person in relation to whom the kind of device is included in the Register, of any information of the kind mentioned in paragraph 5.4(3A)(a) or (b) that the manufacturer becomes aware of in relation to the kind of medical device.
5.4 Requirements of product quality management system
(1) A quality management system that is to be assessed under clause 5.3 must meet the requirements of this clause.
(2) The system must be of a kind such that its application will ensure that each medical device, or representative sample of each batch of medical devices, is examined and tested to ensure that the device, or representative sample:
(a) for a kind of device in relation to which the type examination procedures have been applied--conforms to the approved type; or
(b) for a kind of device to which the declaration of conformity (not requiring assessment by Secretary) procedures have been applied--is in accordance with the technical documentation prepared under clause 6.4 of those procedures for the device.
(3) The system must include post - marketing requirements under which the manufacturer of a medical device to which the system is applied is required:
(a) to systematically review experience gained in the post - production phase in relation to medical devices of that kind; and
(b) to implement appropriate means to apply any necessary corrective action in relation to the design or production of such devices; and
(c) to:
(i) if the manufacturer arranged for assessment of the system under clause 5.3 by the Secretary--notify the Secretary, or the person in relation to whom the kind of device is included in the Register, as soon as practicable after becoming aware of information referred to in subclause (3A); or
(ii) if the manufacturer arranged for assessment of the system under clause 5.3 by an Australian conformity assessment body--notify the body, or the person in relation to whom the kind of device is included in the Register, as soon as practicable after becoming aware of information referred to in subclause (3A).
Note: See also paragraph 41FN(3)(d) and sections 41MP and 41MPA of the Act in relation to the requirement to give certain information about a medical device to the Secretary.
(3A) For the purposes of subparagraphs (3)(c)(i) and (ii), the information is the following:
(a) information relating to:
(i) any malfunction or deterioration in the characteristics or performance of the kind of device; or
(ii) any inadequacy in the design, production, labelling, instructions for use or advertising materials of the kind of device; or
(iii) any use in accordance with, or contrary to, the use intended by the manufacturer of the kind of device;
that might lead, or might have led, to the death of a patient or a user of the device, or to a serious deterioration in his or her state of health;
(b) information relating to any technical or medical reason for a malfunction or deterioration of a kind mentioned in subparagraph (a)(i) that has led the manufacturer to take steps to recall devices of that kind that have been distributed.
(4) Each requirement of the system must be documented in a systematic and orderly way in the form of written policies and procedures (for example, as quality programs, quality plans, quality manuals or quality records).
(5) The documentation of the system must include adequate information in relation to the following matters:
(a) the manufacturer's quality objectives;
(b) the organisation of the manufacturer's business, including, in particular, a description of the following:
(i) the organisational structure of the business;
(ii) the responsibilities of managerial staff and their authority in relation to the quality of the medical devices manufactured by the manufacturer;
(iii) the methods of monitoring whether the system is operating effectively, in particular, whether the desired quality of product is being achieved and how products that fail to meet the desired quality are controlled;
(c) the examinations and tests to be carried out after manufacture, including, in particular, information about:
(i) the frequency with which the examinations and tests are to be carried out; and
(ii) the equipment (including the traceability of the calibration of the equipment) to be used to carry out the examinations and tests;
(d) the quality records to be kept, including, for example, records in relation to inspections, tests, calibration of equipment and qualifications of staff.
5.5 Changes to product quality management system or kinds of medical device
(1) This clause applies to the manufacturer of a medical device if:
(a) the manufacturer has implemented, and had assessed under clause 5.3 of this Schedule, a quality management system that is to be applied to the device; and
(b) after assessment, the manufacturer plans to make:
(i) a substantial change to the system; or
(ii) a change to the kinds of medical devices to which the system is to be applied.
(2) The manufacturer must:
(a) notify the Secretary or an Australian conformity assessment body, in writing, of the proposed change; and
(b) arrange for assessment of the change by the Secretary or the Australian conformity assessment body to verify whether the system, as changed, meets the requirements of clause 5.4 of this Schedule.
(3) For the purpose of enabling the assessment to be carried out, the manufacturer must have available, in writing, details of any consequential changes to the information and documentation required under subclause 5.3(2) of this Schedule in relation to the system or kinds of devices.
(4) After any change to the quality management system, the manufacturer must ensure that the changed system continues to meet the requirements of clause 5.4 of this Schedule.
5.6 Information to be given to authorised person
(1) If requested to do so by an authorised person, the manufacturer of a medical device must:
(a) give to the Secretary any of the following information in relation to the quality management system or the kinds of medical device to which the system is applied:
(i) a copy of the documentation mentioned in subclause 5.4(5) of this Schedule;
(ii) the quality records in relation to the final inspection and testing of the kinds of medical device to which the system is applied (for example, inspection reports, test data, calibration data, information about the qualifications of staff); and
(b) arrange for tests specified by the authorised person to be carried out for the purpose of checking whether the quality management system is operating effectively.
(2) If any inspections or tests are carried out by an authorised person in relation to the manufacturer's premises, or medical devices manufactured by the manufacturer, the manufacturer may ask the authorised person to give to the manufacturer a report stating the findings of the inspections or tests.
(1) The manufacturer of a Class IIb medical device to which a quality management system that has been assessed under clause 5.3 of this Schedule has been applied must make a declaration of conformity in relation to the kind of device.
Note: This clause need not be applied to the following kinds of medical devices if the declaration of conformity (not requiring assessment by Secretary) procedures have been applied to the device:
(a) a Class IIa medical device (see Division 3.2, subparagraph 3.8(1)(b)(iii));
(b) a Class I medical device that has a measuring function (see Division 3.2, paragraph 3.9(3)(c)).
(2) The declaration must:
(a) state that the declaration is a declaration of conformity made under clause 5.7 of Schedule 3 to the Therapeutic Goods (Medical Devices) Regulations 2002 ; and
(b) state the name and business address of the manufacturer of the device; and
(c) state the following information in relation to each kind of medical device to which the system has been applied:
(i) the unique product identifier;
(ii) the medical device classification;
(iii) the device nomenclature system code; and
(d) if the system has not been applied to all medical devices of that kind manufactured by the manufacturer--give details of the medical devices to which the system has been applied (for example, by reference to lot numbers, batches or serial numbers, or by specifying the kinds of medical devices or the times of manufacture); and
(e) for a kind of device in relation to which the type examination procedures have been applied--state that:
(i) the type examination procedures have been applied to the kind of device; and
(ii) the kind of device conforms to the approved type; and
(f) for a kind of device to which the declaration of conformity (not requiring assessment by Secretary) procedures have been applied--state that the kind of device is in accordance with the technical documentation prepared under clause 6.4 of those procedures for the kind of device; and
(g) state the identification number of the conformity assessment certificate, or of the Australian conformity assessment body certificate, issued in relation to the system or the kind of medical devices to which the system has been applied; and
(h) give details of any conformity assessment standard that has been applied to the system; and
(i) be signed by a person authorised by the manufacturer; and
(j) set out the name and position of the person signing the declaration; and
(k) state the date when the declaration is signed.
(1) The manufacturer of a kind of medical device to which a quality management system that has been assessed under clause 5.3 of this Schedule has been applied must keep the following records in relation to the system and the kind of device:
(a) the documentation mentioned in subclause 5.4(5) of this Schedule;
(b) details of any changes made to the system and to the information and documentation required under subclause 5.5(3) of this Schedule;
(c) details of any changes made to the kinds of medical devices to which the system was applied;
(d) for a Class IIb medical device--the declaration of conformity under clause 5.7 of this Schedule;
(e) any notice, report, certificate or other document in relation to the system issued to the manufacturer by the Secretary or an Australian conformity assessment body.
(2) The manufacturer must keep the records for at least 5 years after the manufacture of the last medical device to which the quality management system was applied.
(3) On request from the Secretary, the manufacturer must make the records available to the Secretary.
Part 6 -- Declaration of conformity (not requiring assessment by Secretary) procedures
The conformity assessment procedures set out in this Part provide for the manufacturer of a kind of medical device:
(a) to prepare technical documentation in relation to the kind of device to enable assessment of the device; and
(b) to make a declaration of conformity in relation to the kind of device; and
(c) to establish and keep up - to - date a post - market monitoring, reporting and corrective action system.
Note: See Division 3.2 in relation to the kinds of medical devices to which these conformity assessment procedures may be applied.
6.2 References to kinds of medical devices
A reference in this Part to a kind of medical device includes a reference to an individual medical device.
(1) The manufacturer of a medical device must prepare technical documentation in relation to the kind of device in a form that, if the Secretary decides to do so, would allow the Secretary to assess whether the device complies with the applicable provisions of the essential principles, the classification rules and these conformity assessment procedures.
(2) For the purpose of enabling an assessment to be carried out, the manufacturer must have available, in writing, the following information and undertakings:
(a) the name and business address of the manufacturer;
(b) details of each manufacturing site where these conformity assessment procedures are to be applied;
(c) all relevant information required to identify the kinds of medical devices to which these conformity assessment procedures are to be applied;
(d) an undertaking by the manufacturer to notify the Secretary, or the person in relation to whom the kind of device is included in the Register, of any information of the kind mentioned in subparagraph 6.5(2)(c)(i) or (ii) that the manufacturer becomes aware of in relation to a kind of medical device.
6.4 Required technical documentation
(1) The technical documentation must include adequate information in relation to the kind of device, and must include, in particular, the following:
(a) a general description of the kind of device, and of any variants of the kind of device that the manufacturer plans to manufacture;
(b) diagrams or drawings of the design of the kind of device, including diagrams or drawings of any components, sub - assemblies or circuits of the kind of device;
(c) any descriptions or explanations that are necessary to enable the diagrams or drawings mentioned in paragraph (b), or the intended operation of the kind of device, to be properly understood;
(d) if the kind of device is intended by the manufacturer to be supplied in a sterile state--a description of the method used to sterilise the kind of device;
(e) details of each medical device standard or conformity assessment standard that has been applied, wholly or in part, to the kind of device;
(f) if no medical device standard or conformity assessment standard has been applied, or a medical device standard or conformity assessment standard has been only partly applied, to the kind of device--the solutions adopted to ensure that each device complies with the applicable provisions of the essential principles;
(g) the results of any design calculations, risk analyses, investigations, technical tests, or any other tests, carried out in relation to the kind of device;
(h) if the kind of device is intended by the manufacturer to be connected to another device--evidence demonstrating that the device will comply with the applicable provisions of the essential principles when it is connected to the other device and both devices are being used for their intended purposes;
(i) a copy of the clinical evidence, in relation to the kind of device, required by the clinical evaluation procedures;
(j) a copy of the information to be provided with the kind of device.
(2) If the manufacturer makes a change to the design or the production of the kind of medical device after the technical documentation has been prepared (for example, because it was necessary to apply corrective action in relation to the kind of device), the manufacturer must revise the technical documentation to take account of the change.
(1) The manufacturer of a medical device to which technical documentation prepared under clause 6.4 of this Schedule applies must establish, and keep up - to - date, a post - marketing system that complies with subclause (2) for use in relation to devices of that kind.
(2) A post - marketing system complies with this subclause in relation to a medical device if the system requires the manufacturer of the device:
(a) to systematically review experience gained in the post - production phase in relation to medical devices of that kind; and
(b) to implement appropriate means to apply any necessary corrective action in relation to the design or production of such devices; and
(c) to notify the Secretary, or the person in relation to whom the kind of device is included in the Register, as soon as practicable after becoming aware of:
(i) information relating to:
(A) any malfunction or deterioration in the characteristics or performance of the kind of device; or
(B) any inadequacy in the design, production, labelling, instructions for use or advertising materials of the kind of device; or
(C) any use in accordance with, or contrary to, the use intended by the manufacturer of the kind of device;
that might lead, or might have led, to the death of a patient or a user of the device, or to a serious deterioration in his or her state of health; or
(ii) information relating to any technical or medical reason for a malfunction or deterioration of a kind mentioned in subparagraph (i) that has led the manufacturer to take steps to recall devices of that kind that have been distributed.
Note: See also paragraph 41FN(3)(d) and sections 41MP and 41MPA of the Act in relation to the requirement to give certain information about a medical device to the Secretary.
(1) The manufacturer of a kind of medical device to which technical documentation prepared under clause 6.4 of this Schedule applies must make a declaration of conformity in relation to the kind of device.
(2) The declaration must:
(a) state that the declaration is a declaration of conformity made under clause 6.6 of Schedule 3 to the Therapeutic Goods (Medical Devices) Regulations 2002 ; and
(b) state the name and business address of the manufacturer of the device; and
(c) state the following information in relation to each kind of medical device to which the technical documentation applies:
(i) the unique product identifier;
(ii) the medical device classification;
(iii) the device nomenclature system code; and
(d) if the technical documentation applies to a Class IIa medical device that the manufacturer intends to be supplied in a sterile state or a Class I medical device that the manufacturer intends to be supplied in a sterile state--state that the production quality assurance procedures have also been applied to the device; and
(e) if the technical documentation applies to a Class IIa medical device that the manufacturer intends to be supplied in a non - sterile state, or a Class I medical device that has a measuring function and that the manufacturer intends to be supplied in a non - sterile state--state which of the following conformity assessment procedures have also been applied to the device:
(i) the verification procedures;
(ii) the production quality assurance procedures;
(iii) the product quality management system procedures; and
(f) if the technical documentation does not apply to all medical devices of that kind manufactured by the manufacturer--give details of the medical devices to which the technical documentation applies (for example, by reference to lot numbers, batches or serial numbers, or by specifying the kinds of medical devices or the times of manufacture); and
(g) state that each kind of medical device to which the technical documentation applies complies with the applicable provisions of the essential principles, the classification rules, and these procedures; and
(h) if the technical documentation applies to any of the following kinds of medical devices:
(i) a Class IIa medical device;
(ii) a Class 2 IVD medical device;
(iii) a Class I medical device that the manufacturer intends to be supplied in a sterile state;
(iv) a Class I medical device that has a measuring function;
state the identification number of the conformity assessment certificate, or of the Australian conformity assessment body certificate, issued in relation to the kind of medical device, or the quality management system that has been applied to the kind of device, as a result of the application to the device of the conformity assessment procedures set out in Part 3, 4 or 5 of this Schedule; and
(i) give details of any medical device standard or conformity assessment standard that has been applied to the device; and
(j) be signed by a person authorised by the manufacturer; and
(k) set out the name and position of the person signing the declaration; and
(l) state the date when the declaration is signed.
(1) The manufacturer of a medical device to which technical documentation prepared under clause 6.4 of this Schedule applies must keep the following records:
(a) the technical documentation prepared under clause 6.4 of this Schedule, including any revisions of the documentation prepared as a result of changes to the design or production of the kind of device;
(b) details of any changes made to the design or production of the kind of medical device and to the documentation required under clause 6.4 of this Schedule;
(c) the declaration of conformity under clause 6.6 of this Schedule.
(2) The manufacturer must keep the records for at least 5 years after the manufacture of the last medical device to which the technical documentation prepared clause 6.4 of this Schedule applies.
(3) On request from the Secretary, the manufacturer must make the records available to the Secretary.
Part 6A -- Procedures applying to Class 1, 2 and 3 in - house IVD medical devices
The conformity assessment procedures set out in this Part provide for the manufacturer of a Class 1 in - house IVD medical device, Class 2 in - house IVD medical device or Class 3 in - house IVD medical device to do the following:
(a) implement procedures relating to the application of a quality management system to the manufacture of the device;
(b) provide information to the Secretary about the quality management system and the device;
(c) establish and keep up - to - date a post - market monitoring, reporting and corrective action system.
Notification of devices being manufactured
(1) The manufacturer of a Class 1 in - house IVD medical device, Class 2 in - house IVD medical device or Class 3 in - house IVD medical device must notify the Secretary, in accordance with subclauses (2) and (3), of all the Class 1, 2 or 3 in - house IVD medical devices being manufactured.
(2) A notification under subclause (1) must:
(a) be in a form approved in writing by the Secretary; and
(b) contain the information required by the form; and
(c) cover each Class 1, 2 or 3 in - house IVD medical device being manufactured at the time the notification is given.
(3) A notification under subclause (1) must be given to the Secretary:
(a) if the manufacturer manufactures one or more Class 1, 2 or 3 in - house IVD medical devices before 1 July 2017--no later than 20 working days after 1 July 2017; and
(b) if, in a financial year, the manufacturer starts to manufacture a Class 1, 2 or 3 in - house IVD medical device not covered by the most recent of any previous notification given to the Secretary under subclause (1)--by the later of the following:
(i) 1 July of the next financial year;
(ii) 20 working days after manufacturing the device for the first time.
Accreditation requirements etc.
(4) The laboratory in which the Class 1, 2 or 3 in - house IVD medical device is manufactured must:
(a) be accredited as a testing laboratory by NATA, or by a conformity assessment body determined by the Secretary, as meeting one of the following standards, as published by the International Organization for Standardization and as amended from time to time:
(i) ISO 15189, Medical laboratories--Requirements for quality and competence ;
(ii) ISO/IEC 17025, General requirement for the competence of testing and calibration laboratories ; and
(b) meet the National Pathology Accreditation Advisory Council standard Requirements for the Development and Use of in - house In Vitro Diagnostic Devices (IVDs) , as amended from time to time.
6A.3 Information to be given to the Secretary
(1) On request by an authorised person, the manufacturer of a Class 1, 2 or 3 in - house IVD medical device must:
(a) give to the Secretary, within the period specified in the request (which must not be less than 20 working days after the request is made), the following information in relation to the device and the quality management system applied to the device:
(i) a copy of the documentation mentioned in subclause (2);
(ii) data for the design of the device (for example, the results of any analysis of the device, calculations or tests);
(iii) data for the manufacture of the device (for example, inspection reports, test data, calibration data, information about the qualifications of staff); and
(b) arrange for tests specified by the authorised person to be carried out for the purpose of checking whether the quality management system is operating effectively.
(2) The documentation must include the following information:
(a) the manufacturer's quality objectives;
(b) the organisation of the manufacturer's business, including a description of the following:
(i) the organisational structure of the business;
(ii) the responsibilities of managerial staff and their authority in relation to the quality of the design and production of medical devices manufactured by the manufacturer;
(iii) the methods of monitoring whether the system is operating effectively, including whether the desired quality of design and product is being achieved and how products that fail to meet the desired quality are controlled;
(c) the design of the medical device to which the system is to be applied, including the following:
(i) details of the processes, systems and measures used for controlling, monitoring and verifying that, at each stage of the design process, the device complies with the applicable provisions of the essential principles;
(ii) a general description of the device;
(iii) details of the design specifications for the device, including:
(A) any medical device standard that has been applied to the device; and
(B) the results of the risk analysis carried out; and
(C) if no medical device standard, or part of it, has been applied to the device--the solutions adopted to ensure that each device complies with the applicable provisions of the essential principles;
(iv) for a device that is intended by the manufacturer to be connected to another device--evidence demonstrating that the device will comply with the applicable provisions of the essential principles when it is connected to the other device and both devices are being used for their intended purposes;
(v) a statement indicating whether or not the device contains viable tissues, cells or substances of human or animal origin;
(vi) a copy of the clinical evidence, in relation to the device, required by the clinical evaluation procedures;
(vii) a copy of the information to be provided with the device, when relevant;
(d) the inspection and quality assurance techniques to be applied in the production of the medical device to which the system is to be applied, including information about the following:
(i) the processes and procedures to be used and the documents relating to those processes and procedures;
(ii) the procedures to be used for purchasing goods or services in relation to the production of the device and the documents relating to those procedures;
(iii) product identification procedures to be prepared and kept up - to - date from drawings, specifications or other documents at each stage of production;
(e) the tests or trials to be carried out before, during and after production of the medical device to which the system is to be applied, including information about:
(i) the frequency with which the tests or trials are to be carried out; and
(ii) the equipment (including the traceability of the calibration of the equipment) used, or to be used, to carry out the tests or trials;
(f) the system for reviewing experience gained in the post - production phase for the medical device to which the quality management system has been applied, and the means by which any necessary corrective action will be applied to the design or production of such devices.
(3) If any inspections or tests are carried out by an authorised person in relation to the manufacturer's premises, or medical devices produced by the manufacturer, the manufacturer may ask the authorised person to give to the manufacturer a report stating the findings of the inspections or tests.
(1) The manufacturer of a Class 1, 2 or 3 in - house IVD medical device must establish, and keep up - to - date, a post - marketing system for use for the device.
(2) The post - marketing system must require the manufacturer of the device to:
(a) systematically review experience gained in the post - production phase for the device; and
(b) implement appropriate means to apply any necessary corrective action for the design or production of the device; and
(c) notify the Secretary as soon as practicable after becoming aware of information relating to any of the following that might lead, or might have led, to the death of a patient or a user of the device, or to a serious deterioration in his or her state of health:
(i) any malfunction or deterioration in the characteristics or performance of the device;
(ii) any inadequacy in the design, production, labelling, instructions for use or advertising materials of the device;
(iii) any use in accordance with, or contrary to, the use intended by the manufacturer of the device.
Part 6B -- Procedures applying to Class 4 in - house IVD medical devices
The conformity assessment procedures set out in this Part provide for the manufacturer of a Class 4 in - house IVD medical device to do the following:
(a) implement a quality management system for the design, production, packaging, labelling and final inspection of that kind of device;
(b) prepare technical documentation in relation to that kind of device;
(c) establish and keep up - to - date a post - market monitoring, reporting and corrective action system;
(d) make a declaration of conformity in relation to that kind of device;
(e) prepare and keep records in relation to these procedures;
(f) notify the Secretary of the manufacture of certain Class 4 in - house IVD medical devices.
6B.2 References to kinds of medical devices
A reference in this Part to a kind of medical device includes a reference to an individual medical device.
(1) The manufacturer of a Class 4 in - house IVD medical device must implement a quality management system for the design, production, packaging, labelling and final inspection of that kind of device.
(2) If the kind of device is used in relation to the manufacture of blood, blood components and plasma derivatives, human cell and tissue based therapeutic goods, either:
(a) the manufacturer must:
(i) satisfy the requirements in the Australian Code of Good Manufacturing Practice for Blood and Blood Components, Human Tissues and Human Cellular Therapy Products , published by the Therapeutic Goods Administration, as amended from time to time; and
(ii) hold a manufacturing licence that is in force and authorises the carrying out of a step in the manufacture of blood, blood components and plasma derivatives, human cell and tissue based therapeutic goods; or
(b) the laboratory in which the kind of device is manufactured must:
(i) be accredited as a testing laboratory by NATA as meeting ISO 15189, Medical laboratories--Requirements for quality and competence , published by the International Organization for Standardization, as amended from time to time; and
(ii) meet the National Pathology Accreditation Advisory Council standard Requirements for the Development and Use of in - house In Vitro Diagnostic Devices (IVDs) , as amended from time to time.
(3) If the kind of device is not used in relation to the manufacture of blood, blood components and plasma derivatives, human cell and tissue based therapeutic goods, the laboratory in which the kind of device is manufactured must:
(a) be accredited as a testing laboratory by NATA as meeting ISO 15189, Medical laboratories--Requirements for quality and competence , published by the International Organization for Standardization, as amended from time to time; and
(b) meet the National Pathology Accreditation Advisory Council standard Requirements for the Development and Use of in - house In Vitro Diagnostic Devices (IVDs) , as amended from time to time.
6B.4 Required technical documentation
(1) The manufacturer of a Class 4 in - house IVD medical device must have available technical documentation for that kind of device that:
(a) is up - to - date; and
(b) is in a form that, if requested by the Secretary, would allow an assessment to be carried out as to whether a device of that kind complies with the applicable provisions of the essential principles, the classification rules, and these conformity assessment procedures; and
(c) contains the information mentioned in subclauses (2) and (3).
(2) The technical documentation must contain information about the kind of device in relation to which the quality management system mentioned in subclause 6B.3(1) of this Part is to be applied, including the following:
(a) details of the processes, systems and measures used for controlling, monitoring and verifying that the kind of device complies with the applicable provisions of the essential principles;
(b) a general description of the kind of device;
(c) details of the design specifications for the kind of device, including:
(i) any medical device standard that has been applied to the kind of device; and
(ii) the results of the risk analysis carried out; and
(iii) if no medical device standard, or part only of such a standard, has been applied to the kind of device--the solutions adopted to ensure that each device of that kind complies with the applicable provisions of the essential principles;
(d) for a kind of device that is intended by the manufacturer to be connected to another device--evidence demonstrating that:
(i) the kind of device will comply with the applicable provisions of the essential principles when it is connected to the other device; and
(ii) both devices are being used for their intended purposes;
(e) a statement indicating whether or not the kind of device contains viable tissues, cells or substances of human or animal origin;
(f) the results of any calculations, investigations, technical tests, or any other tests, carried out by the manufacturer in relation to the kind of device;
(g) a copy of the clinical evidence, in relation to the kind of device, required by the clinical evaluation procedures;
(h) a copy of the information to be provided with the kind of device (if any).
(3) The technical documentation must also contain information about the method or methods of manufacture of the kind of device.
(1) The manufacturer of a Class 4 in - house IVD medical device must establish, and keep up - to - date, a post - marketing system for use for a device of that kind.
(2) The post - marketing system must require the manufacturer to:
(a) systematically review experience gained in the post - production phase for devices of that kind; and
(b) implement appropriate means to apply any necessary corrective action for the design or production of those devices; and
(c) notify the Secretary as soon as practicable after becoming aware of information relating to any of the following that might lead, or might have led, to the death of a patient or a user of the device, or to a serious deterioration in his or her state of health:
(i) any malfunction or deterioration in the characteristics or performance of the kind of device;
(ii) any inadequacy in the design, production, labelling, instructions for use or advertising materials of the kind of device;
(iii) any use in accordance with, or contrary to, the use intended by the manufacturer of the kind of device.
6B.6 Declaration of conformity
(1) The manufacturer of a Class 4 in - house IVD medical device to which these conformity assessment procedures have been applied must make a declaration of conformity in relation to the kind of device.
(2) The declaration must:
(a) state that the declaration is a declaration of conformity made under clause 6B.6 of Part 6B of Schedule 3 to the Therapeutic Goods (Medical Devices) Regulations 2002 ; and
(b) state the name and business address of the manufacturer of the device; and
(c) state the following information for the kind of device in relation to which the quality management system mentioned in subclause 6B.3(1) of this Part has been applied:
(i) the unique product identifier;
(ii) the medical device classification;
(iii) the device nomenclature system code; and
(d) state that the kind of device in relation to which the quality management system has been applied complies with the applicable provisions of the essential principles, the classification rules, and these conformity assessment procedures; and
(e) if the kind of device is used in relation to the manufacture of blood, blood components and plasma derivatives, human cell and tissue based therapeutic goods--either:
(i) state that the manufacturer satisfies the requirements in the Australian Code of Good Manufacturing Practice for Blood and Blood Components, Human Tissues and Human Cellular Therapy Products , as mentioned in subparagraph 6B.3(2)(a)(i), and state the number of the manufacturing licence held by the manufacturer, as mentioned in subparagraph 6B.3(2)(a)(ii); or
(ii) state that the laboratory in which the kind of device is manufactured meets the requirements mentioned in subparagraphs 6B.3(2)(b)(i) and (ii), and state the NATA accreditation number issued to the laboratory; and
(f) if the kind of device is not used in relation to the manufacture of blood, blood components and plasma derivatives, human cell and tissue based therapeutic goods--state that the laboratory in which the kind of device is manufactured meets the requirements mentioned in paragraphs 6B.3(3)(a) and (b), and state the NATA accreditation number issued to the laboratory; and
(g) be signed by a person authorised by the manufacturer; and
(h) set out the name and position of the person signing the declaration; and
(i) state the date when the declaration is signed.
(1) The manufacturer of a Class 4 in - house IVD medical device to which these conformity assessment procedures have been applied must keep the following records in relation to the procedures and the kind of device:
(a) the technical documentation mentioned in clause 6B.4 of this Part;
(b) details of any changes made to the kind of device and to the technical documentation in relation to the design or production of the kind of device;
(c) the declaration of conformity under clause 6B.6 of this Part;
(d) details of any systematic review carried out, after production, in relation to devices of that kind.
(2) The manufacturer must keep the records for at least 5 years after the manufacturer stops manufacturing devices of that kind.
(3) On request from the Secretary, and within such reasonable period as is set out in the request, the manufacturer must make the records available to the Secretary.
6B.8 Notification of certain Class 4 in - house IVD medical devices being manufactured
(1) The manufacturer of a kind of Class 4 in - house IVD medical device that the manufacturer intends to be used to detect the presence of, or exposure to, transmissible agents in blood, stool or other specimens from a person's body in order to assess the suitability of the person to be a donor of human stool for use in the manufacture of a faecal microbiota transplant product must notify the Secretary, in accordance with subclauses (2) and (3), about that kind.
(2) A notification under subclause (1) must:
(a) be in a form approved in writing by the Secretary; and
(b) contain the information required by the form.
(3) A notification under subclause (1) must be given to the Secretary:
(a) if the manufacturer manufactures such a kind of Class 4 in - house IVD medical device on or after the commencement of this clause and before 1 July 2021--no later than 20 working days after 1 July 2021; and
(b) if, on or after 1 July 2021, the manufacturer manufactures such a kind of Class 4 in - house IVD medical device--no later than 20 working days after the manufacture.
(4) Only one notification is required under this clause in relation to each kind of Class 4 in - house IVD medical device manufactured by a manufacturer.
Part 7 -- Procedures for medical devices used for a special purpose
The conformity assessment procedures set out in this Part provide for the manufacturer of a medical device used for a special purpose:
(a) to prepare a written statement containing certain information in relation to the device and to provide a copy of the statement with the device; and
(b) to prepare and keep up - to - date particular documentation in relation to the device.
7.2 Custom - made medical devices
(1) This clause applies to a custom - made medical device.
(2) The manufacturer of the device must prepare a written statement in relation to the device including the following:
(a) the name and business address of the manufacturer;
(b) sufficient information to enable the user to identify the device or, if relevant, the contents of packaging;
(c) a statement to the effect that the device is intended by the manufacturer to be for the sole use of a particular patient or health professional;
(d) the name of the individual in relation to whom the device is intended to be used;
(e) the name and business address of the health professional who made the request for the device;
(f) the particular design characteristics of the device as specified by the health professional who made the request for the device;
(g) a statement to the effect that the device complies with the applicable provisions of the essential principles or, if the device does not comply with all applicable provisions of the essential principles, a statement explaining which provisions of the essential principles the device does not comply with and the reasons for the non - compliance.
(3) The statement must:
(a) be signed by a person authorised by the manufacturer of the device; and
(b) set out the name and position of the person signing the statement; and
(c) state the date when the statement is signed.
(3A) The manufacturer must provide a copy of the statement with the device.
(4) The manufacturer must prepare, and keep up - to - date, documentation in relation to the device, including information in relation to the design, production and intended performance of the device.
(5) The manufacturer must take all measures necessary to ensure that the process used to manufacture the device results in the device complying with the documentation mentioned in subclause (4).
(6) The manufacturer must notify the Secretary as soon as practicable after becoming aware of:
(a) information relating to:
(i) any malfunction or deterioration in the characteristics or performance of the device; or
(ii) any inadequacy in the design, production, labelling or instructions for use of the device; or
(iii) any use in accordance with, or contrary to, the use intended by the manufacturer of the device;
that might lead, or might have led, to the death of a patient or a user of the device, or to a serious deterioration in his or her state of health; or
(b) information relating to any technical or medical reason for a malfunction or deterioration of a kind mentioned in paragraph (a) that has led the manufacturer to take steps to recall a device that has been distributed.
Note: Clauses 7.3 and 7.4 are intentionally not used.
(1) The manufacturer of a system or procedure pack must make a declaration of conformity in relation to the system or procedure pack.
(2) The declaration must:
(a) state that the declaration is a declaration of conformity made under clause 7.5 of Schedule 3 to the Therapeutic Goods (Medical Devices) Regulations 2002 ; and
(b) state the name and business address of the manufacturer of the system or procedure pack; and
(c) state sufficient information to enable the user to identify the system or procedure pack or the contents of the system or procedure pack; and
(d) identify each item in the system or procedure pack; and
(e) except in relation to a medical device covered by paragraph (ia)--state that the manufacturer has:
(i) a conformity assessment document, a declaration of conformity under clause 6.6 or a statement under subclause 7.2(2) for each medical device in the system or procedure pack for which such a document, declaration or statement is required; and
(ii) evidence that each medical device in the system or procedure pack complies with the applicable provisions of the essential principles; and
(f) state the registration or listing number for each medicine or other therapeutic goods, or the biological number for each biological, in the system or procedure pack; and
(g) state that each medical device in the system or procedure pack is intended to be used for its original intended purpose, and each medicine, biological or other therapeutic goods in the system or procedure pack is intended to be used within the approved indications of the medicine, biological or other therapeutic goods; and
(h) state that the mutual compatibility of each medical device, medicine, biological or other therapeutic goods, and any other goods, in the system or procedure pack has been verified in accordance with:
(i) the instructions for use of each medical device included in the system or procedure pack, being the instructions for use provided by the manufacturer of the device; and
(ii) the approved indications of each medicine, biological and other therapeutic goods (if any) included in the system or procedure pack; and
(ha) state that the manufacturer of the system or procedure pack has manufactured the system or procedure pack in accordance with the instructions referred to in subparagraph (h)(i) and the indications referred to in subparagraph (h)(ii); and
(i) state that the information supplied with the system or procedure pack for the use of the system or procedure pack includes instructions for use provided by the manufacturer of each item in the system or procedure pack; and
(ia) if the manufacturer of the system or procedure pack has modified the packaging of any medical device included in the system or procedure pack or modified any medical device included in the system or procedure pack--state the matters covered by subclause (2A); and
(j) state that the process of manufacturing the system or procedure pack, and the verification and packaging (if any) of the system or procedure pack, has been subjected to a documented method of internal control and inspection that ensures the safety, quality, performance and effectiveness of each item in the system or procedure pack; and
(k) if the system or procedure pack is intended by the manufacturer to be supplied in a sterile state--state that the full quality assurance procedures (other than clause 1.6), or the production quality assurance procedures (other than clause 4.7), have been applied to the system or procedure pack in accordance with:
(i) the instructions for use of each medical device included in the system or procedure pack, being the instructions for use provided by the manufacturer of the device; and
(ii) the approved indications of each medicine, biological and other therapeutic goods (if any) included in the system or procedure pack; and
(l) be signed by a person authorised by the manufacturer; and
(m) set out the name and position of the person signing the declaration; and
(n) state the date when the declaration is signed.
(2A) For the purposes of paragraph (2)(ia), the matters are the following:
(a) that the modification has not affected the quality, safety or performance of the medical device;
(b) if the modification has not been done in accordance with the instructions for use of the medical device provided by the manufacturer of the device--that the manufacturer of the system or procedure pack has:
(i) if a conformity assessment document, a declaration of conformity under clause 6.6 or a statement under subclause 7.2(2) is required for the medical device--such a document, declaration or statement for the medical device, as affected by the modification; and
(ii) evidence that the medical device, as affected by the modification, complies with the applicable provisions of the essential principles.
(2B) If the manufacturer of a system or procedure pack has modified the packaging of any medical device included in the system or procedure pack or modified any medical device included in the system or procedure pack:
(a) the manufacturer of the system or procedure pack must ensure that the modification does not affect the quality, safety or performance of the medical device; and
(b) if the modification has not been done in accordance with the instructions for use of the medical device provided by the manufacturer of the device--the manufacturer of the system or procedure pack must have:
(i) if a conformity assessment document, a declaration of conformity under clause 6.6 or a statement under subclause 7.2(2) is required for the medical device--such a document, declaration or statement for the medical device, as affected by the modification; and
(ii) evidence that the medical device, as affected by the modification, complies with the applicable provisions of the essential principles.
(3) The manufacturer of a system or procedure pack must establish, and keep up - to - date, a post - marketing system that complies with subclause (4) for use in relation to the system or procedure pack.
(4) A post - marketing system complies with this subclause in relation to a system or procedure pack if the post - marketing system requires the manufacturer of the system or procedure pack:
(a) to systematically review experience gained in the post - production phase in relation to the system or procedure pack; and
(b) to implement appropriate means to apply any necessary corrective action in relation to the production of the system or procedure pack; and
(c) to notify the Secretary as soon as practicable after becoming aware of:
(i) information relating to:
(A) any malfunction or deterioration in the characteristics or performance of the system or procedure pack; or
(B) any inadequacy in the production, labelling, instructions for use or advertising materials of the system or procedure pack; or
(C) any use in accordance with, or contrary to, the use intended by the manufacturer of the system or procedure pack;
that might lead, or might have led, to the death of a patient or a user of the system or procedure pack, or to a serious deterioration in his or her state of health; or
(ii) information relating to any technical or medical reason for a malfunction or deterioration of a kind mentioned in subparagraph (i) that has led the manufacturer to take steps to recall system or procedure packs of that kind that have been distributed.
Note: See also paragraph 41FN(3)(d) and sections 41MP and 41MPA of the Act in relation to the requirement to give certain information about a medical device to the Secretary.
(1) The manufacturer must keep the statement and documentation required under the relevant clause of this Schedule in relation to a medical device to which the conformity assessment procedures in this Part have been applied.
(2) The manufacturer must keep the statement and documentation for at least:
(a) if the device is not an implantable medical device--5 years after the manufacture of the medical device to which the statement and documentation relate; or
(b) if the device is an implantable medical device--15 years after the manufacture of the medical device to which the statement and documentation relate.
(3) On request from the Secretary, the manufacturer must make the statement and documentation available to the Secretary.
Part 8 -- Clinical evaluation procedures
The conformity assessment procedures set out in this Part provide for the manufacturer of a kind of medical device to obtain and evaluate clinical data in relation to the kind of device.
Note: See regulation 3.11 in relation to the kinds of medical devices to which these conformity assessment procedures must be applied.
8.2 References to kinds of medical devices
A reference in this Part to a kind of medical device includes a reference to an individual medical device.
(1) The manufacturer of a kind of medical device must obtain clinical data in relation to the device in the form of either or both of the following:
(a) clinical investigation data in accordance with clause 8.4;
(b) a literature review in accordance with clause 8.5.
(2) The manufacturer must ensure that the clinical data obtained takes account of any medical device standard or conformity assessment standard that may apply to the device.
8.4 Clinical investigation data
(1) For clause 8.3, clinical investigation data , in relation to a kind of medical device, includes:
(a) documentation in relation to the design, approval, conduct and results of each investigation carried out by the manufacturer of the device in relation to the use of the device in or on a human body; and
(b) a record of qualitative or quantitative information obtained through observation, measurement, tests or any other means used to assess the operation of the device; and
(c) a written report by an expert in the relevant field, being a report that contains a critical evaluation of all the clinical investigation data held in relation to the device.
(2) The documentation mentioned in paragraph (1)(a) must be in a form that allows the manufacturer to evaluate whether the device complies with the applicable provisions of the essential principles.
(3) The record mentioned in paragraph (1)(b) must be in a form that allows the information in it to be independently assessed and verified.
(4) If clinical investigation data is collected in Australia, the investigation must have been conducted in accordance with the ethical standards set out in the 'National Statement on Ethical Conduct in Research Involving Humans', published by the National Health and Medical Research Council, as in force from time to time.
(5) If clinical investigation data is collected outside Australia, the investigation must have been conducted in accordance with the principles of the Declaration of Helsinki, as in force at the time and place where the investigation was conducted.
For clause 8.3, a literature review , in relation to a kind of medical device, includes:
(a) a compilation, prepared using a documented methodology, of published literature and unpublished scientific literature, both favourable and unfavourable, relating to medical devices of that kind, including the following:
(i) expert opinion;
(ii) information about the hazards and associated risks arising from the use of the device for its intended purpose, and the foreseeable misuse of the device;
(iii) information about the performance of devices of that kind, including a description of the techniques used to examine whether devices of that kind achieve their intended purpose; and
(b) a written report by an expert in the relevant field, being a report that contains a critical evaluation of the compilation of literature mentioned in paragraph (a).
8.6 Evaluation of clinical data
(1) The manufacturer of a kind of medical device must ensure that the clinical data is evaluated by competent clinical experts.
(2) The manufacturer must ensure that clinical evidence demonstrating that the device complies with the applicable provisions of the essential principles is documented in writing.