Commonwealth Consolidated Regulations Commonwealth Consolidated Regulations(regulation 9.1)
Item | Matter | Provision of Act or these Regulations | Amount ($) |
1.1 | Application for conformity assessment certificate | Paragraph 41EB(2)(a) of the Act | 1,483 |
1.1A | Application for conformity assessment (priority applicant) determination in relation to a medical device | Paragraph 41ECA(3)(d) of the Act | 11,065 |
1.2 | (a) Review of conformity assessment certificate--surveillance assessment for conformity assessment certificate issued under conformity assessment procedures set out in Schedule 3, Part 1, 4 or 5 Note 1: If the assessment involves an assessment of a medicinal component, an additional fee is payable--see item 1.11. Note 2: If a supplementary assessment, or an assessment outside Australia, is required, an additional fee is payable--see item 1.12 and clause 2.1 of this Schedule. | Subsection 41EJ(4) of the Act | 9,733 |
| (b) Review of conformity assessment certificate for an IVD medical device--surveillance assessment for conformity assessment certificate issued under conformity assessment procedures set out in Schedule 3, Part 1 or 4 |
| 9,786 |
1.3 | Review of conformity assessment certificate for a medical device, other than an IVD medical device--in relation to certification of compliance with the essential principles for conformity assessment certificate issued under conformity assessment procedures set out in: | Subsection 41EJ(4) of the Act |
|
| (a) Schedule 3, clause 1.6; or |
| 59,511 |
| (b) Schedule 3, Part 2 (including management of testing, analysis, and reporting on examination of the type) |
| 45,869 |
| Note 1: If the assessment involves an assessment of a medicinal component, an additional fee is payable--see item 1.11. Note 2: If a supplementary assessment, or an assessment outside Australia, is required, an additional fee is payable--see item 1.12 and clause 2.1 of this Schedule. Note 3: For an assessment under paragraph (b), an additional fee to cover the costs of testing the relevant kind of medical device is also payable--see clause 2.2 of this Schedule. |
|
|
1.3A | Review of conformity assessment certificate for an IVD medical device in relation to certification of compliance with the essential principles for conformity assessment certificate issued under conformity assessment procedures set out in: | Subsection 41EJ(4) of the Act |
|
| (a) Schedule 3, Part 1--Full Quality Management System; or |
| 33,623 |
| (b) Schedule 3, clause 1.6--Design Examination; or |
| 71,650 |
| (c) Schedule 3, clause 1.6--Design Examination - Immunohaematology reagent medical devices; or |
| 17,402 |
| (d) Schedule 3, clause 1.6--Abridged Design Examination - previously registered IVDs; or |
| 4,222 |
| (e) Schedule 3, Part 2--Type Examination; or |
| 46,299 |
| (f) Schedule 3, Part 4--Production Quality Management System |
| 29,541 |
| Note 1: If a supplementary assessment, or an assessment outside Australia, is required, an additional fee is payable--see item 1.12 and clause 2.1 of this Schedule. Note 2: For an assessment under paragraph (e), an additional fee to cover the costs of testing the relevant kind of medical device is also payable--see item 2.2 of this Schedule. |
|
|
1.4 | Considering a submission to the Secretary in relation to a proposed suspension of a conformity assessment certificate, including a conformity assessment certificate for an IVD medical device | Subsection 41EN(2) and paragraph 63(2)(h) of the Act | For a medical device, other than an IVD medical device--the fee applicable under item 1.14 to the kind of work to be undertaken |
|
|
| For an IVD medical device--the fee applicable under item 1.14A, 1.14AA, 1.14B or 1.14C (as the case may be) to the kind of work to be undertaken |
1.4A | Application for full designation conformity assessment body determination | Paragraph 41EWA(3)(d) of the Act | 5,322 |
1.4B | Application for partial designation conformity assessment body determination (full QMS) | Paragraph 41EWA(3)(d) of the Act | 2,926 |
1.4C | Application for partial designation conformity assessment body determination (partial QMS or partial devices) | Paragraph 41EWA(3)(d) of the Act | 2,926 |
1.4D | Assessment of application for full designation conformity assessment body determination | Paragraph 41EWA(3)(g) of the Act | 86,903 |
1.4E | Assessment of application for partial designation conformity assessment body determination (full QMS) | Paragraph 41EWA(3)(g) of the Act | 62,380 |
1.4F | Assessment of application for partial designation conformity assessment body determination (partial QMS or partial devices) | Paragraph 41EWA(3)(g) of the Act | 62,380 |
1.5 | Application for the following kinds of medical devices to be included in the Register: | Paragraph 41FDB(2)(b) of the Act |
|
| (b) a Class III medical device; |
| 1,483 |
| (c) a Class IIb medical device; |
| 1,150 |
| (d) a Class IIa medical device; |
| 1,150 |
| (e) a Class I medical device that the manufacturer intends to be supplied in a sterile state or that has a measuring function, except a device that is intended by the manufacturer to be for export only; |
| 602 |
| (f) a Class I medical device that is intended by the manufacturer to be for export only; |
| 96 |
| (g) a Class I medical device except one described in paragraph (e) or (f); |
| 602 |
| (h) an IVD medical device, including a Class 4 in - house IVD medical device, but not a device that is intended by the manufacturer to be for export only or a Class 2 IVD medical device that was, immediately before the commencement of the Therapeutic Goods (Medical Devices) Amendment (In Vitro Diagnostic Medical Devices) Regulation 2015 : (i) included in the Register; and (ii) classified as a Class 3 IVD medical device because of subclause 1.3(2) of Schedule 2A (as in force immediately before the commencement of that regulation) |
| 1,150 |
| Note: Paragraph (h)--there is no fee for an application to include in the Register a Class 2 IVD medical device mentioned in the paragraph. |
|
|
| (i) an IVD medical device that is intended by the manufacturer to be for export only |
| 96 |
1.5A | Application for medical devices (priority applicant) determination in relation to a medical device | Paragraph 41FKA(3)(d) of the Act | 11,641 |
1.6 | Considering submissions to the Secretary in relation to a proposed suspension of a kind of medical device, including an IVD medical device, from the Register | Subsection 41GB(2) and paragraph 63(2)(h) of the Act | The fee applicable under item 1.14 to the kind of work to be undertaken |
1.6A | Request for the revocation of the cancellation of an entry of a kind of medical device from the Register: | Paragraph 41GLA(1)(c) of the Act |
|
| (a) if the request relates to one entry; |
| 181 |
| (b) if the request relates to more than one entry |
| 181 for the first entry plus 57 for each additional entry |
1.6B | Request for the revocation of the cancellation of an entry of a kind of medical device from the Register: | Paragraph 41GLB(1)(d) of the Act |
|
| (a) if the request relates to one entry; |
| 181 |
| (b) if the request relates to more than one entry |
| 181 for the first entry plus 57 for each additional entry |
1.7 | Application for approval to use a specified kind of medical device, including an IVD medical device, solely for experimental purposes in humans | Paragraph 41HB(5)(c) of the Act | 21,697 |
1.7A | Request to vary a medical device, or kind of medical device, specified in an approval to use that device or kind of device solely for experimental purposes in humans, or to vary the conditions of such an approval | Paragraph 41HB(8)(e) of the Act | 5,922 |
1.8 | Each of the following: | Paragraph 63(2)(h) of the Act, and Schedule 4, item 2.3, paragraphs (b) and (ha) of these Regulations |
|
| (a) notification of intention to sponsor a clinical trial of a medical device, including an IVD medical device, to be used solely for experimental purposes in humans, at a trial site; |
| 429 |
| (b) each notification of an additional trial site or additional trial sites for the clinical trial |
| 429 |
1.9 | Conformity assessment--initial assessment under conformity assessment procedures for a medical device, other than an IVD medical device, set out in: | Subsections 41LA(1) and (2) of the Act |
|
| (a) Schedule 3, Part 1; or |
| 33,516 |
| (b) Schedule 3, clause 1.6; or |
| 65,850 |
| (c) Schedule 3, Part 2 (including management of testing, analysis, and reporting on examination of the type); or |
| 45,869 |
| (d) Schedule 3, Part 3 (including management of testing, analysis, and reporting on verification of the type); or |
| 32,119 |
| (e) Schedule 3, Part 4; or |
| 29,326 |
| (f) Schedule 3, Part 5 Note 1: If the assessment involves an assessment of a medicinal component, an additional fee is payable--see item 1.11. |
| 25,030 |
| Note 2: If a supplementary assessment, or an assessment outside Australia, is required, an additional fee is payable--see item 1.12 and clause 2.1 of this Schedule. |
|
|
| Note 3: For an assessment under paragraph (c) or (d), an additional fee to cover the costs of testing the relevant kind of medical device is also payable--see clause 2.2 of this Schedule. Note 4: If the assessment is abridged, a reduced fee is payable--see regulation 9.4. |
|
|
1.9A | Conformity assessment for an IVD medical device--initial assessment under conformity assessment procedures set out in: | Subsections 41LA(1) and (2) of the Act |
|
| (a) Schedule 3, Part 1--Full Quality Management System; or |
| 33,623 |
| (b) Schedule 3, clause 1.6--Design Examination; or |
| 71,650 |
| (c) Schedule 3, clause 1.6--Design Examination - Immunohaemotology reagent medical devices; or |
| 17,402 |
| (d) Schedule 3, clause 1.6--Abridged Design Examination - previously registered IVDs; or |
| 4,222 |
| (e) Schedule 3, Part 2--Type Examination; or |
| 46,299 |
| (f) Schedule 3, Part 4--Production Quality Management System |
| 29,541 |
| Note 1: If a supplementary assessment, or an assessment outside Australia, is required, an additional fee is payable--see item 1.12 and clause 2.1 of this Schedule. |
|
|
| Note 2: For an assessment under paragraph (e), an additional fee to cover the costs of testing the relevant kind of medical device is also payable--see clause 2.2 of this Schedule. Note 3: If the assessment is abridged, a reduced fee is payable--see regulation 9.4. |
|
|
1.10 | Conformity assessment--assessment consequent on change to medical device, other than an IVD medical device, or quality management system applying to medical device, other than an IVD medical device, under conformity assessment procedures set out in: | Subsections 41LA(1) and (2) of the Act |
|
| (a) Schedule 3, Part 1; or |
| 20,196 |
| (b) Schedule 3, clause 1.6; or |
| 39,746 |
| (c) Schedule 3, Part 2 (including management of testing, analysis, and reporting on examination of the type); or |
| 27,715 |
| (d) Schedule 3, Part 4; or |
| 17,402 |
| (e) Schedule 3, Part 5 Note 1: If the assessment involves an assessment of a medicinal component, an additional fee is payable--see item 1.11. |
| 15,254 |
| Note 2: If a supplementary assessment, or an assessment outside Australia, is required, an additional fee is payable--see item 1.12 and clause 2.1 of this Schedule. |
|
|
| Note 3: For an assessment under paragraph (c), an additional fee to cover the costs of testing the relevant kind of medical device, or quality management system, is also payable--see clause 2.2 of this Schedule. |
|
|
Conformity assessment--assessment because of changes or proposed changes to an IVD medical device or quality management system applying to that device, under conformity assessment procedures set out in: | Subsections 41LA(1) and (2) of the Act |
| |
| (a) Schedule 3, Part 1--Full Quality Management System; or |
| 20,174 |
| (b) Schedule 3, clause 1.6--Design Examination; or |
| 42,990 |
| (c) Schedule 3, clause 1.6--Design Examination - Immunohaematology reagent medical devices; or |
| 10,442 |
| (d) Schedule 3, clause 1.6--Abridged Design Examination - previously registered IVDs; or |
| 2,533 |
| (e) Schedule 3, Part 2--Type Examination; or |
| 27,780 |
| (f) Schedule 3, Part 4--Production Quality Management System |
| 17,725 |
| Note 1: If a supplementary assessment, or an assessment outside Australia, is required, an additional fee is payable--see item 1.12 and clause 2.1 of this Schedule. |
|
|
| Note 2: For an assessment under Schedule 3, Part 2, an additional fee to cover the costs of testing the relevant kind of medical device, or quality management system, is also payable--see clause 2.2 of this Schedule. |
|
|
1.11 | If an assessment of a medical device involves an assessment of the medicinal component of the device--for an assessment of the data relating to the medicinal component (and in addition to the fee required under item 1.2, 1.3, 1.9 or 1.10) | Subsections 41EJ(4) and 41LA(1) and (2) of the Act | The fee applicable under item 4, or paragraph |
1.12 | If a supplementary assessment of a medical device is required, in addition to the assessment mentioned in item 1.2, 1.3, 1.9, 1.9A, 1.10 or 1.10A Note: For an assessment conducted outside Australia, an additional fee is payable--see clause 2.1 of this Schedule. | Subsections 41EJ(4) and 41LA(1) and (2) of the Act | 496 for each hour for each assessor involved |
1.13 | Application audit assessment, Level 1--verification of sponsor's application and evidence of conformity | Subsections 41LA(3) and (4) of the Act | 4,554 |
1.14 | Application audit assessment, Level 2--for Level 1 activities and review of evidence of conformity for the following kinds of medical device: | Subsections 41LA(3) and (4) of the Act |
|
| (a) Class III medical devices (other than IVD medical devices); |
| 16,752 |
| (b) all other medical devices (other than IVD medical devices) |
| 4,188 |
1.14A | Application audit assessment for the following kinds of medical devices: | Subsections 41LA(3) and (4) of the Act |
|
| (a) Class 1 and Class 2 IVD medical devices; |
| 7,734 |
| (b) Class 3 IVD medical devices, other than devices to which item 1.14AA applies; |
| 23,439 |
| (c) Class 4 IVD medical devices, other than: (i) Class 4 IVD medical devices that are immunohaematology reagent IVD medical devices; or (ii) devices to which item 1.14AA, 1.14B or 1.14C applies; |
| 23,439 |
| (d) Class 4 IVD medical devices that are immunohaematology reagent IVD medical devices |
| 17,402 |
1.14AA | Application audit assessment for Class 3 IVD medical devices or Class 4 IVD medical devices (other than devices to which paragraph (d) of item 1.14A, or item 1.14C, applies), where the devices are not subject to laboratory testing as part of the auditing of the application | Subsections 41LA(3) and (4) of the Act | 14,865 |
1.14B | Application audit assessment for Class 4 in - house IVD medical devices (other than a device to which item 1.14AA or 1.14C applies) | Subsections 41LA(3) and (4) of the Act | 23,439 |
1.14C | Application audit assessment for Class 4 in - house IVD medical devices that are immunohaematology reagent IVD medical devices | Subsections 41LA(3) and (4) of the Act | 17,402 |
1.15 | Application for consent of Secretary to importation into Australia, supply for use in Australia, or exportation from Australia of a medical device, including an IVD medical device: | Sections 41MA and 41MAA and paragraph 63(2)(h) of the Act |
|
| (a) for an application relating to a medical device that is not included in the Register or to a medical device to which a single entry in the Register relates; or |
| Subject to regulation 9.1AA, 565 (for all the devices to which the application relates) |
| (b) for an application relating to medical devices to which both of the following apply: (i) there are separate entries in the Register in relation to the devices; (ii) the way in which the devices do not comply with essential principles is the same for all the devices |
| Subject to regulation 9.1AA, 565 for the first entry plus 113 for each additional entry |
1.16 | Intermediate stage assessment or verification procedures to be carried out in relation to the application of the conformity assessment procedures to an article | Subregulation 3.13(1) of these Regulations | The fee applicable under item 1.9, 1.10 or 1.12 to the kind of work to be undertaken |
1.17 | Notification by a manufacturer, under subclause 6A.2(1) of Part 6A of Schedule 3, of Class 1, 2 or 3 in - house IVD medical devices being manufactured | Subsection 63(1) and paragraph 63(2)(h) of the Act | 1,209 |
In addition to the assessment fee mentioned in item 1.2, 1.3, 1.9, 1.9A, 1.10 or 1.10A of this Schedule, the following fees apply:
(a) for each assessment that is required to be conducted--an amount that reimburses the costs and reasonable expenses of travel by each assessor involved, including travel both in and outside Australia;
(b) for an assessment that is required to be conducted outside Australia--an amount calculated at the rate of $496 for each hour of preparation by each assessor involved.
(1) In addition to the assessment fee mentioned in paragraph 1.3(b), 1.3A(e), 1.9(c) or (d), 1.9A(e) or paragraph 1.10(c) of this Schedule, a fee for the costs of testing the relevant kind of medical device, or quality management system, applies.
(2) The fee is the amount that reimburses the Department for:
(a) the costs incurred in purchasing, establishing and setting - up the equipment to be used to conduct the tests; and
(b) the direct costs of conducting the tests (including the cost of any consumables used in conducting the tests).
(regulation 1.3)
Note: A number of expressions used in these Regulations are defined in the Act.
"Act" means the Therapeutic Goods Act 1989 .
"active implantable medical device" means an active medical device, other than an implantable medical device, that is intended by the manufacturer:
(a) either:
(i) to be, by surgical or medical intervention, introduced wholly, or partially, into the body of a human being; or
(ii) to be, by medical intervention, introduced into a natural orifice in the body of a human being; and
(b) to remain in place after the procedure.
"active medical device" :
(a) means a medical device that is intended by the manufacturer:
(i) to depend for its operation on a source of electrical energy or other source of energy (other than a source of energy generated directly by a human being or gravity); and
(ii) to act by converting this energy; but
(b) does not include a medical device that is intended by the manufacturer to transmit energy, a substance, or any other element, between an active medical device and a human being without any significant change in the energy, substance or other element being transmitted.
Software that is a medical device is an active medical device .
"active medical device for diagnosis" means an active medical device that is intended by the manufacturer to be used on a human being, either alone or in combination with another medical device, to supply information for the purpose of detecting, diagnosing, monitoring or treating physiological conditions, states of health, illnesses or congenital deformities.
"active medical device for therapy" means an active medical device that is intended by the manufacturer to be used on a human being, either alone or in combination with another medical device, to support, modify, replace or restore biological functions or structures for the purpose of treating or alleviating an illness, injury or handicap.
"adaptable medical device" means a mass - produced medical device that is intended by the manufacturer to be assembled or adapted after it has been supplied, in accordance with the manufacturer's instructions, to:
(a) address either or both of the anatomical and physiological features of a particular individual; or
(b) address a pathological condition of a particular individual; or
(c) otherwise perform as intended by the manufacturer.
"AHPRA number" , of a health practitioner, means the registration number published by the Australian Health Practitioner Regulation Agency in relation to the health practitioner.
"ancillary medical device" means an implantable medical device that:
(a) consists of screws, plates or wedges; or
(b) is intended by the manufacturer to be used to:
(i) provide stability for an implantable medical device that is intended to (either alone or together with one or more other implantable medical devices) replace the shoulder joint, hip joint or knee joint; or
(ii) provide bone substitution in relation to, or additional fixation for, any such device; or
(iii) otherwise assist any such device;
where the individual requirements of a patient make it appropriate to do so.
"animal" means an invertebrate or vertebrate member of the animal kingdom.
"approved indications" , of a medicine, biological or other therapeutic goods, means:
(a) if the medicine, biological or other therapeutic goods are entered on the Register--the indications included in the Register in relation to the medicine, biological or other therapeutic goods; or
(b) otherwise--the indications in relation to the medicine, biological or other therapeutic goods.
Note: For indications , see subsection 3(1) of the Act.
"approved type" means a type that has been examined and approved by the Secretary under the type examination procedures.
"Australian legal unit of measurement" has the meaning given by the National Measurement Act 1960 .
"authorised person--" see regulation 10.1.
"body orifice" :
(a) means a natural opening, or a permanent artificial opening, in a human being's body; and
(b) includes the external surface of a human being's eyeball.
"central circulatory system" means the system in a human being comprising the following vessels:
(a) arteriae pulmonales ;
(b) aorta ascendens ;
(c) arteriae coronariae ;
(d) arteria carotis communis ;
(e) arteria carotis externa ;
(f) arteria carotis interna ;
(g) arteriae cerebrales ;
(h) trucus brachicephalicus ;
(i) venae cordis ;
(j) venae pulmonales ;
(k) venae cava superior ;
(l) venae cava inferior ;
(m) arcus aorta ;
(n) thoracica aorta ;
(o) abdominalis aorta ;
(p) arteriae ilica communis.
"central nervous system" means the system in a human being comprising the brain, meninges and spinal cord.
"Class 1 in-house IVD medical device" means an in - house IVD medical device that, under Division 3.1 of Part 3, is classified as Class 1.
"Class 1 IVD medical device" means an IVD medical device that, under Division 3.1 of Part 3, is classified as Class 1.
"Class I medical device" means a medical device that, under Division 3.1 of Part 3, is classified as Class I.
"Class 2 in-house IVD medical device" means an in - house IVD medical device that, under Division 3.1 of Part 3, is classified as Class 2.
"Class 2 IVD medical device" means an IVD medical device that, under Division 3.1 of Part 3, is classified as Class 2.
"Class IIa medical device" means a medical device that, under Division 3.1 of Part 3, is classified as Class IIa.
"Class IIb medical device" means a medical device that, under Division 3.1 of Part 3, is classified as Class IIb.
"Class 3 in-house IVD medical device" means an in - house IVD medical device that, under Division 3.1 of Part 3, is classified as Class 3.
"Class 3 IVD medical device" means an IVD medical device that, under Division 3.1 of Part 3, is classified as Class 3.
"Class III medical device" means a medical device that, under Division 3.1 of Part 3, is classified as Class III.
"Class 4 in-house IVD medical device" means an in - house IVD medical device that, under Division 3.1 of Part 3, is classified as Class 4.
"Class 4 IVD medical device" means an IVD medical device that, under Division 3.1 of Part 3, is classified as Class 4.
"classification" means a medical device classification.
"classification rules" , in relation to a medical device, means the rules for classifying the device set out in Schedule 2.
"client" of an Australian conformity assessment body means a manufacturer with whom the body has an agreement under which the body will carry on certification - related activities, including issuing Australian conformity assessment body certificates to the manufacturer.
"clinical evaluation procedures" means the conformity assessment procedures set out in Part 8 of Schedule 3.
"conformity assessment body determination assessment fee" means a fee payable under regulation 9.1B for assessing an application for a conformity assessment body determination.
"conformity assessment (priority applicant) determination" has the meaning given by subsection 41ECA(2) of the Act.
"custom-made medical device" means a medical device that:
(a) is intended by the manufacturer to be for:
(i) the sole use of a particular patient (the intended recipient ); or
(ii) the sole use of a particular health professional (the intended recipient ) in the course of the health professional's practice; and
(b) is manufactured by the manufacturer in accordance with a written request of a health professional (the requesting health professional ) and with particular design characteristics specified by that health professional in the request (even if the design is developed in consultation with the manufacturer), where those design characteristics are intended to address:
(i) either or both of the anatomical and physiological features of the intended recipient; or
(ii) a pathological condition of the intended recipient; and
(c) the requesting health professional has determined is necessary to address the matters covered by paragraph (b) because there is no kind of medical device included in the Register to address those matters or to address those matters to an appropriate level.
However, a custom - made medical device does not include a patient - matched medical device, an adaptable medical device or other mass - produced medical device.
"declaration of conformity (not requiring assessment by Secretary) procedures" means the conformity assessment procedures set out in Part 6 of Schedule 3.
"device lifetime" , in relation to a medical device, means the period, indicated by the manufacturer, during which:
(a) the device can be safely used; and
(b) the characteristics and performance of the device are not affected by its age.
"device nomenclature system code" , for a medical device, means the device nomenclature system code mentioned for the device in regulation 1.7.
"essential principles" means the essential principles set out in Schedule 1.
"EU IVD regulation" has the meaning given by subclause 2(3) of Schedule 3AA.
"EU medical devices regulation" has the meaning given by subclause 2(2) of Schedule 3AA.
"faecal microbiota transplant product" means a thing that:
(a) comprises, contains or is derived from human stool; and
(b) is for introduction into a person for a therapeutic use.
"full designation conformity assessment body determination" means a conformity assessment body determination that is of general application.
"full quality assurance procedures" means the conformity assessment procedures set out in Part 1 of Schedule 3.
"health professional" includes a person who is:
(a) a medical practitioner, or a dentist or any other kind of health care worker registered under a law of a State or Territory; or
(b) a biomedical engineer, chiropractor, optometrist, orthodontist, osteopath, pharmacist, physiotherapist, podiatrist, prosthetist or rehabilitation engineer.
"hip joint" means the ball and socket formed by the reception of the head of the femur into the cup - shaped cavity of the acetabulum.
"immunohaematology reagent IVD medical device" means an IVD medical device that is a reagent, reagent product or related material that is intended by the manufacturer to be used to provide information about blood groups, red cell antigens or red cell antibodies, or to determine compatibility of blood or blood components for transfusion.
"implantable breast medical device" means any of the following implantable medical devices:
(a) breast implants or mammary implants;
(b) breast tissue expanders;
(c) any other medical device that is of a similar kind, or has a similar function, to a medical device mentioned in paragraph (a) or (b).
"implantable cardiac medical device" means any of the following implantable medical devices or active implantable medical devices:
(a) cardiac stents;
(b) cardiac valves (whether mechanical or of biological origin);
(c) electronic devices for regulating heart rate or managing dysrhythmia;
(d) any other medical device that is of a similar kind, or has a similar function, to a medical device mentioned in paragraph (a), (b) or (c).
"implantable medical device" means a medical device (other than an active implantable medical device) that is intended by the manufacturer:
(a) to be, by surgical intervention, wholly introduced into the body of a human being, and to remain in place after the procedure; or
(b) to replace, by surgical intervention, an epithelial surface, or the surface of an eye, of a human being, and to remain in place after the procedure; or
(c) to be, by surgical intervention, partially introduced into the body of a human being, and to remain in place for at least 30 days after the procedure.
"in-house IVD medical device" means an IVD medical device that is:
(a) within the confines or scope of an Australian laboratory or Australian laboratory network:
(i) developed from first principles; or
(ii) developed or modified from a published source; or
(iii) developed or modified from any other source; or
(iv) used for a purpose, other than the intended purpose assigned by the manufacturer; and
(b) not supplied for use outside that laboratory or laboratory network.
"injured skin or mucous membrane" means an area of skin or mucous membrane that has evidence of:
(a) a pathological change; or
(b) a change following:
(i) disease; or
(ii) a wound.
"instructions for use" , in relation to a medical device, includes information provided by the manufacturer of the device to inform a user of the device of the intended purpose of the device, of the proper use of the device and of any precautions to be taken in relation to the use of the device.
Note: These Regulations contain requirements relating to instructions for use of a medical device. For example, clauses 13.1 to 13.4 of Schedule 1 (about essential principles) deal with information that must be included in instructions for the use of a medical device.
"intended purpose" , of a medical device, means the purpose for which the manufacturer of the device intends it to be used, as stated in:
(a) the information provided with the device; or
(b) the instructions for use of the device; or
(c) any advertising material applying to the device; or
(d) any technical documentation describing the mechanism of action of the device.
"invasive medical device" means a medical device that is intended by the manufacturer to be used, in whole or in part, to penetrate the body of a human being through a body orifice or through the surface of the body.
"IVD companion diagnostic" means an IVD medical device:
(a) that is intended by the manufacturer to be used for the examination of a specimen from the body of an individual:
(i) to identify whether the individual would be likely to benefit from the use of a particular medicine or biological; or
(ii) to identify whether the individual is likely to be at particular risk of a serious adverse reaction to the use of a particular medicine or biological; or
(iii) to monitor the individual's response to the use of a particular medicine or biological; and
(b) that is mentioned in product information for the medicine or biological as being essential for the safe and effective use of the medicine or biological; and
(c) if the medicine or biological comprises blood, a blood component, cells, tissue or an organ, from a donor other than the individual--that is not intended by the manufacturer to be used for the examination of the specimen merely to determine whether the medicine or biological is compatible with the individual.
"IVD medical device" , or in vitro diagnostic medical device, means a medical device that is:
(a) a reagent, calibrator, control material, kit, specimen receptacle, software, instrument, apparatus, equipment or system, whether used alone or in combination with another diagnostic product for in vitro use; and
(b) intended by the manufacturer to be used in vitro for the examination of a specimen derived from the human body, solely or principally for:
(i) giving information about a physiological or pathological state or a congenital abnormality; or
(ii) determining safety and compatibility with a potential recipient; or
(iii) monitoring therapeutic measures; and
(c) not a product that is:
(i) intended for general laboratory use; and
(ii) not manufactured, sold or presented for use as an IVD medical device.
"IVD medical device for self-testing" means an IVD medical device intended to be used:
(a) in the home or similar environment by a lay person; or
(b) in the collection of a sample by a lay person and, if that sample is tested by another person, the results are returned directly to the person from whom the sample was taken without the direct supervision of a health professional who has formal training in a medical field or discipline to which the self - testing relates.
"joint replacement medical device" means an implantable medical device:
(a) that is intended by the manufacturer to operate (either alone or together with one or more other implantable medical devices) as a replacement (in whole or in part) for the shoulder joint, hip joint or knee joint; and
(b) that (either alone or together with one or more other implantable medical devices):
(i) replaces or substitutes for the articulating surface of a shoulder joint, hip joint or knee joint (in whole or in part); or
(ii) provides primary fixation to the bone for the replacement articulating surface; or
(iii) connects directly or indirectly with an implantable medical device that has a function mentioned in subparagraph (i) or (ii) and operates as an intrinsic element of the joint replacement;
but does not include an ancillary medical device.
"kind" , in relation to a medical device--see section 41BE of the Act.
"knee joint" means the joint consisting of:
(a) the articulations between each of the 2 condyles of the femur and the corresponding surface of the tibia; and
(b) the articulation between the patella and the trochlear groove of the femur.
"laboratory network" means a network of laboratory organisations that satisfies the following:
(a) the network operates with a single quality management system;
(b) either:
(i) the activities of the network span more than one field of testing or program; or
(ii) the network operates at multiple sites within a field, or involves a combination of multiple sites and fields or programs.
"lay person" , for the use of an IVD medical device for self - testing, means an individual who does not have formal training in a medical field or discipline to which the self - testing relates.
"manufacturing licence" --see subsection 38(1B) of the Act.
"mass-produced medical device" means a medical device that:
(a) is manufactured according to standardised dimensions or designs; and
(b) is not designed for a particular individual; and
(c) is manufactured in a continuous production process or in a homogenous batch.
"measuring function" , in relation to a medical device--see regulation 1.4.
"medical device production system" means a system that consists of raw materials and main production equipment (whether or not the system also consists of software), where the system is intended by the manufacturer to be used (whether or not with ancillary inputs or equipment) by a health professional, or suitably qualified person within a healthcare facility, to produce a particular medical device for use in relation to a patient of the health professional or healthcare facility.
"medical devices (priority applicant) determination" has the meaning given by subsection 41FKA(2) of the Act.
"medical device used for a special purpose" means a medical device to which regulation 3.10 applies.
"nanomaterial" has the meaning given by Article 2(18) of Regulation 2017/745 (as in force from time to time) of the European Parliament and the Council of the European Union.
"NATA" means the National Association of Testing Authorities.
"partial designation conformity assessment body determination (full QMS)" means a conformity assessment body determination that is not:
(a) a full designation conformity assessment body determination; or
(b) a partial designation conformity assessment body determination (partial QMS or partial devices).
"partial designation conformity assessment body determination (partial QMS or partial devices)" means a conformity assessment body determination that:
(a) is not a full designation conformity assessment body determination; and
(b) covers:
(i) the conformity assessment procedures set out in clause 1.6 or Part 2 of Schedule 3 (whether or not the determination also covers other procedures); or
(ii) a Class III medical device (whether or not the determination also covers other medical devices).
"patient implant card" has the meaning given by clause 13A.2 of Schedule 1.
"patient information leaflet" has the meaning given by clause 13A.3 of Schedule 1.
"patient-matched medical device" means a medical device that:
(a) is manufactured by the manufacturer, within a specified design envelope, to match:
(i) either or both of the anatomical and physiological features of a particular individual; or
(ii) a pathological condition of a particular individual; and
(b) is designed by the manufacturer (even if the design is developed in consultation with a health professional); and
(c) is manufactured using production processes that are capable of being:
(i) either or both validated and verified; and
(ii) reproduced.
"point of care testing" , for an IVD medical device, means testing performed outside the laboratory environment, near to or at the side of the patient, that is not done under the supervision of a trained laboratory professional.
"post-production phase" , in relation to a medical device, means the period during which the device is stored, transported, supplied for use and used (whether in Australia or not).
"principal investigator" , in relation to a clinical trial of a kind of medical device, means the person who is in charge of the conduct of the trial.
"procedures for medical devices used for a special purpose" means the conformity assessment procedures set out in Part 7 of Schedule 3.
"production quality assurance procedures" means the conformity assessment procedures set out in Part 4 of Schedule 3.
"product quality assurance procedures" means the conformity assessment procedures set out in Part 5 of Schedule 3.
"refurbishment" , of a medical device--see regulation 1.5.
"residual risk" for a medical device has the meaning given by subclause 2(3) of Schedule 1.
"reusable surgical instrument" means a medical device that is intended by the manufacturer:
(a) to be used surgically, without being connected to an active medical device, for cutting, drilling, sawing, scratching, scraping, clamping, retracting, clipping or any other similar procedure; and
(b) to be reused after the appropriate procedures (such as cleaning, disinfection and sterilisation) specified by the manufacturer in the instructions for use have been carried out.
"sample" , for an IVD medical device for self - testing, means 1 or more specimens, taken from the human body, that:
(a) are intended to provide information on the human body; and
(b) may serve as a basis for a decision on the human body or its processes.
"serious" , for a condition, ailment or defect, means a condition, ailment or defect that is:
(a) generally accepted as not being appropriate to be diagnosed or treated without consulting a medical practitioner, or a dentist or other kind of health care worker registered under a law of a State or Territory; or
(b) generally accepted to be beyond the ability of the average person to evaluate accurately, or treat safely, without supervision by a medical practitioner, or a dentist or other kind of health care worker registered under a law of a State or Territory.
"serious disease" means a disease that:
(a) may result in death or long - term disability; and
(b) may be incurable or require major therapeutic interventions; and
(c) must be diagnosed accurately, to mitigate the public health impact of the disease.
"shoulder joint" means the ball and socket formed by the reception of the head of the humerus onto the glenoid cavity of the scapula.
"specialist" has the same meaning as in the Health Insurance Act 1973 .
"specified design envelope" means minimum and maximum dimensions, performance limits or other relevant factors that:
(a) characterise a medical device for production purposes; and
(b) may be based on a standard device template.
"surgically invasive medical device" means:
(a) an invasive medical device that is intended by the manufacturer to be used with the aid, or in the context, of a surgical operation; and
(b) a medical device that is intended by the manufacturer to be used to penetrate the body of a human being in any way other than through a body orifice.
"therapeutic cannabis vaping device" means a medical device that:
(a) is a vaping device, other than:
(i) a disposable therapeutic vape (within the meaning of the Therapeutic Goods Regulations 1990 ); or
(ii) a component or article imported for use in the manufacture of a therapeutic cannabis vaping device; and
(b) is intended, by the person under whose name the device is or is to be supplied, to be used only to administer medicinal cannabis products (within the meaning of that instrument) or medicines containing synthetic cannabis.
"therapeutic cannabis vaping device accessory" means a therapeutic good that is an unfilled cartridge, capsule, pod or other vessel:
(a) that is designed or intended only for use in, or with, a therapeutic cannabis vaping device; and
(b) that is designed or intended to contain a therapeutic vaping substance; and
(c) whether or not the cartridge, capsule, pod or other vessel is designed or intended to be refilled.
"therapeutic cannabis vaping good" means a therapeutic cannabis vaping device or a therapeutic cannabis vaping device accessory.
"therapeutic vaping device" means a therapeutic good that is a vaping device, other than:
(a) a disposable therapeutic vape (within the meaning of the Therapeutic Goods Regulations 1990 ); or
(b) a therapeutic cannabis vaping device.
"therapeutic vaping device accessory" means a therapeutic good that is an unfilled cartridge, capsule, pod or other vessel:
(a) that is designed or intended for use in, or with, a therapeutic vaping device; and
(b) that is designed or intended to contain a therapeutic vaping substance; and
(c) whether or not the cartridge, capsule, pod or other vessel is designed or intended to be refilled;
but does not include a therapeutic cannabis vaping device accessory.
"therapeutic vaping substance" has the same meaning as in the Therapeutic Goods Regulations 1990 .
"type" means a representative sample of a kind of medical device.
"type examination procedures" means the conformity assessment procedures set out in Part 2 of Schedule 3.
"unique product identifier" of a medical device means the unique product identifier (for example, the product name or model number) given to the device by its manufacturer to identify the device and any variants.
"unused emergency medical devices" means medical devices to which section 41GY of the Act applies.
"user" of a medical device means any person (including a health professional) who uses the device.
"variant" means a medical device, the design of which has been varied, to accommodate different patient anatomical requirements (for example, relating to the shape, size, length, diameter or gauge of the device) or any other variation approved by the Secretary for this definition, if the variation does not change the intended purpose of the device.
"verification procedures" means the conformity assessment procedures set out in Part 3 of Schedule 3.