1.1

Medical device that is imported into Australia for use in the treatment of the importer, or a member of the importer's immediate family, or for use in the in vitro examination of a specimen obtained from the importer or a member of the importer's immediate family, if:

(a) the device does not contain a substance the importation of which is prohibited under the Customs Act 1901 ; and

(ab) the device is not a device referred to in item   1.1A; and

(b) in the case of:

(i) a device, other than an IVD medical device, that is manufactured using tissues, tissue derivatives, cells or substances of animal origin that have been rendered non - viable, or tissues, cells or substances of bacterial or recombinant origin; or

(ii) a device, other than an IVD medical device, that incorporates, or is intended to incorporate, as an integral part, a stable derivative of human blood or blood plasma--

  the device is the subject of an approval under section   41HB of the Act; and

(c) in the case of a Class 4 IVD medical device, Class III medical device, Class 3 IVD medical device, Class IIb medical device, Class 2 IVD medical device or Class IIa medical device:

(i) the quantity imported in one importation is not more than the amount required to give 3 months use of the device according to:

(A) the treating medical practitioner's directions; or

(B) the manufacturer's instructions for use of the device; or

(C) directions, recommendations or advice of a Commonwealth, State or Territory authority that has functions in relation to, or that is responsible for or deals with, health matters; and

(ii) the total quantity imported in a 12 month period is not more than the amount required to give 15 months use of the device according to:

(A) the treating medical practitioner's directions; or

(B) the manufacturer's instructions for use of the device; or

(C) directions, recommendations or advice of a Commonwealth, State or Territory authority that has functions in relation to, or that is responsible for or deals with, health matters; and

(d) in the case of a device that is subject to Schedule   4 or Schedule   8 to the current Poisons Standard, or a device that incorporates, or is intended to incorporate, as an integral part, a substance that is subject to either of those Schedules--the device, or substance, is acknowledged in writing by a medical practitioner to be appropriate treatment for the importer or family member (unless the device is carried by the importer as a passenger on a ship or an aeroplane)

1.1A

Medical devices that are therapeutic vaping devices, therapeutic vaping device accessories, therapeutic cannabis vaping devices or therapeutic cannabis vaping device accessories, imported into Australia by a person (the first person ) on board a ship or aircraft, if:

(a) the medical devices are for use in the treatment of the first person or one or more other persons on board the ship or aircraft who are under the care of the first person; and

(b) the importation of the medical devices meets the requirements of paragraph   5(2)(b) or subregulation   5A(2) of the Customs (Prohibited Imports) Regulations   1956

1.2

Medical device that is exported from Australia and:

(a) is not intended for commercial supply; and

(b) does not contain a substance the export of which is prohibited under the Customs Act 1901 ; and

(c) is not intended for use for experimental purposes on humans

1.3

Samples of a medical device that is imported into Australia, exported from Australia, or manufactured or supplied in Australia for any of the following purposes (other than for supply for use in or on a human being):

(a) submission to a regulatory authority;

(b) subjection to developmental or quality control procedures;

(c) examination, demonstration or display, with notice included to the effect that the device is not available for general supply unless it is included in the Register;

(d) subjection to analysis, evaluation or laboratory testing procedures;

(e) use in the manufacture of goods including therapeutic goods;

(f) testing performed on a specimen taken from a cadaver (except to assess whether a part of the cadaver is suitable for transfusion or transplantation)

1.3A

Medical device that is an oxygen administration hood for use in a hyperbaric chamber for hyperbaric oxygen therapy

1.3B

Medical device that is:

(a) manufactured by a health professional or by a person acting under the written instructions of a health professional; and

(b) manufactured from other medical devices that are included in the Register and are covered by item   3A, 3B, 3C, 3D or 3E of the table in Schedule   1 to the Therapeutic Goods (Medical Devices--Specified Articles) Instrument 2020 , as that instrument is in force from time to time

1.4

Medical device that:

(a) is imported into Australia solely for the purpose of being exported from Australia; and

(b) while in Australia, remains subject to customs control under the Customs Act 1901 ; and

(c) is not subject to any of the activities mentioned in section   41BG of the Act by a manufacturer in Australia

1.4A

Medical device that is prescription spectacle lenses (whether or not supplied with a mounting) if the lenses (disregarding any lens treatments) are intended, by the person under whose name the device is or is to be supplied, to be used only to provide refractive corrections

1.7

Patient - matched medical device

2.1

Medical device that is imported into Australia, if:

(a) the device is not a device referred to in item   2.17; and

(b) the device is held under the direct control of the sponsor, until the device is:

(i) the subject of a notification under item   2.3; or

(ii) approved for importation into Australia under section   41HB or 41HD of the Act; or

(iii) authorised for supply under section   41HC of the Act; or

(iv) used for a Category A patient, within the meaning of regulation   7.2; or

(v) exported from Australia

(a) The supply of the device must be in accordance with the relevant notification, approval, authorisation or medical practitioner's direction.

(b) The device must be kept in a warehouse or properly secured area under the control of the sponsor.

(c) For a device that is a therapeutic cannabis vaping good--the sponsor has, before importing the device, given the Secretary a notice, in a form approved in writing by the Secretary, stating that:

(i) the device complies with the essential principles, or is imported or supplied (as the case may be) with the consent of the Secretary under section   41MA or 41MAA of the Act ; and

(ii) the sponsor holds information or evidence to support the statement made for the purposes of subparagraph   (i).

(d) The sponsor must:

(i) keep records relating to the source and supply of the device; and

(iii) if requested by the Secretary, give the records to the Secretary.

2.2

Medical device affected by section   41FH of the Act that is imported into Australia and is held under the direct control of the sponsor until a decision is made under section   41FI of the Act in relation to the device

(a) The sponsor must:

(i) keep records relating to the source of the device; and

(ii) if requested by the Secretary, give the records to the Secretary; and

(iii) before importing the device, have lodged an application under section   41FC of the Act for the device to be included in the Register.

(b) If the application is not successful, the device must be destroyed or returned to the consignor of the device within 1   month of the decision not to include the device in the Register.

2.3

Medical device to be used in a clinical trial solely for experimental purposes in humans

(a) The sponsor must notify the Secretary:

(i) in a form approved by the Secretary; and

(ii) in accordance with the requirements (if any) determined by the Secretary for the form of notification;

  about the trial and the medical device covered by the trial and must do so before:

(iii) the medical device begins to be used in the trial, unless subparagraph   (iv) applies; or

(iv) if the sponsor seeks the Secretary's agreement to the notification being given before the end of a period nominated by the sponsor and the Secretary agrees to this--the end of that nominated period.

(b) The notification must be accompanied by the notification fee specified in paragraph   (a) of item   1.8 of Schedule   5.

(c) The approval of the device for this purpose must be given by the sponsor (if the sponsor is conducting the trial), or by the body or organisation conducting the trial for the sponsor, having regard to the advice of the ethics committee that has, or will assume, responsibility for monitoring the conduct of the trial.

(d) The terms of the approval by the sponsor, body or organisation mentioned in paragraph   (c) must be no less restrictive than the terms advised by the responsible ethics committee.

(e) The trial must not be the subject of a direction by the Secretary that the trial not be conducted, or that it be stopped, because the Secretary has become aware that to conduct or continue the trial would be contrary to the public interest.

(f) The sponsor (if the sponsor is conducting the trial), or the body or organisation conducting the trial for the sponsor, must not receive, or have received, advice from the responsible ethics committee that is inconsistent with the continuation of the trial.

(g) The conditions stated in regulation   7.5 must be complied with, as if that regulation applied to a person using a medical device under this item.

(h) The sponsor must notify the Secretary:

(i) in a form approved by the Secretary; and

(ii) in accordance with the requirements (if any) determined by the Secretary for the form of notification;

  about any trial site not covered by the notification referred to in paragraph   (a) and must do so before:

(iii) the medical device begins to be used at that site, unless subparagraph   (iv) applies; or

(iv) if the sponsor seeks the Secretary's agreement to the notification being given before the end of a period nominated by the sponsor and the Secretary agrees to this--the end of that nominated period.

(ha) The notification must be accompanied by the notification fee specified in paragraph   (b) of item   1.8 of Schedule   5.

(i) The sponsor must comply with requests by an authorised person, whether made before or after the start of the trial, to give information about the conduct of the trial (whether or not the sponsor is conducting the trial).

(j) If a body or organisation is conducting the trial for the sponsor, that body or organisation must comply with requests by an authorised person, whether made before or after the start of the trial, to give information about the conduct of the trial.

(k) The sponsor (if the sponsor is conducting the trial), or the body or organisation conducting the trial for the sponsor, must allow an authorised person to do the things mentioned in regulation   7.4.

(l) The sponsor must:

(i) if requested in writing by the Secretary, give the Secretary specified information or documents relating to the safety or performance of the medical device covered by the trial; and

(ii) do so within 14 days of receiving the request or such longer period (if any) allowed in writing by the Secretary.

2.4

Medical device that is imported into Australia by a member of a group of persons who are visiting Australia to participate in a national or international sporting event

(a) The device must be for use in the treatment of a member or members of the visiting group.

(b) The importation of the device must not be prohibited under the Customs (Prohibited Imports) Regulations   1956 .

(c) The device must not be supplied to, or used in the treatment of, a person who is not a member of the visiting group.

(d) The device must be destroyed or removed from Australia at the end of the visit.

(e) A member of the group must be responsible for the control and custody of the device while the group is in Australia.

(f) The person mentioned in paragraph   (e) must:

(i) carry a list, in English, of the quantity and nature of the device imported; and

(ii) keep a record of the use of the device while the group is in Australia; and

(iii) produce the list or record for inspection at the request of a customs officer or a person who is an authorised person for the purposes of section   41FN of the Act.

2.5

Medical device that is imported into Australia by a member of a group of persons, being members of the military forces of another country who are visiting Australia for military training

(a) The device must be for use in the treatment of a member or members of the visiting group.

(b) The device must not be supplied to, or used in the treatment of, a person other than a member of:

(i) the visiting group; or

(ii) the Australian Defence Force.

(c) The device must be destroyed or removed from Australia at the end of the visit.

(d) A member of the group to whom the device has been issued must be responsible for the control and custody of the device while the group is in Australia.

(e) The person mentioned in paragraph   (d) must:

(i) carry a list, in English, of the quantity and nature of the device imported; and

(ii) keep a record of the use of the device while the group is in Australia; and

(iii) produce the list or record for inspection at the request of a customs officer or a person who is an authorised person for the purposes of section   41FN of the Act.

2.6

Medical device that is imported into Australia by a medical practitioner or a member of a medical team (being 1 or more persons under the professional supervision of a medical practitioner)

(a) The medical practitioner or medical team must be accompanying a person to Australia who:

(i) has a critical illness; and

(ii) is under the direct care and supervision of the practitioner or team.

(b) The device must be for use in the treatment of the person who has the critical illness.

(c) The importation of the device must not be prohibited under the Customs (Prohibited Imports) Regulations   1956 .

(d) The quantity of the device imported must be consistent with the quantity required for the treatment of the person mentioned in paragraph   (b).

(e) The device must not be supplied to, or used in the treatment of, a person other than the person mentioned in paragraph   (b).

(f) The device must be destroyed or removed from Australia at the end of the visit.

(g) The medical practitioner, or a member of the medical team, must be responsible for the control and custody of the device while the practitioner or team is in Australia.

(h) The person mentioned in paragraph   (g) must:

(i) carry a list, in English, of the quantity and nature of the device imported; and

(ii) keep a record of the use of the device while the medical practitioner or medical team is in Australia; and

(iii) produce the list or record for inspection at the request of a customs officer or a person who is an authorised person for the purposes of section   41FN of the Act.

2.7

Medical device that is imported into Australia by a member of a group of persons, being a group that includes a person who is the Head of State or Head of Government of a foreign country and senior Government officials of that country, who are visiting Australia on official business

(a) The device must be for use in the treatment of a member or members of the visiting group.

(b) The importation of the device must not be prohibited under the Customs (Prohibited Imports) Regulations   1956 .

(c) The device must not be supplied to, or used in the treatment of, a person other than a member of the visiting group.

(d) The device must be destroyed or removed from Australia at the end of the visit.

(e) A member of the visiting group must be responsible for the control and custody of the device while the group is in Australia.

(f) The person mentioned in paragraph   (e) must:

(i) carry a list, in English, of the quantity and nature of the device imported; and

(ii) keep a record of the use of the device while the group is in Australia; and

(iii) produce the list or record for inspection at the request of a customs officer or a person who is an authorised person for the purposes of section   41FN of the Act.

2.8

Medical device that is part of the medical supplies of a ship (including a yacht or other marine vessel) or aircraft visiting Australia

(a) The device must be for use in the treatment of a passenger or a member of the crew travelling on the ship or aircraft.

(b) The importation of the device must not be prohibited under the Customs (Prohibited Imports) Regulations   1956 .

(c) The quantity of the device imported must be consistent with the quantity required for the treatment of passengers and members of the crew travelling on the ship or aircraft.

(d) The device must not be supplied to, or used in the treatment of, a person other than a passenger or a member of the crew travelling on the ship or aircraft.

(e) The device must not be removed from the ship or aircraft while the ship or aircraft is in Australia.

(f) The master of the ship or the pilot of the aircraft must be responsible for the control and custody of the device while the ship or aircraft is in Australia.

(g) The person mentioned in paragraph   (f) must:

(i) carry a list, in English, of the quantity and nature of the device imported; and

(ii) keep a record of the use of the device while the ship or aircraft is in Australia; and

(iii) produce the list or record for inspection at the request of a customs officer or a person who is an authorised person for the purposes of section   41FN of the Act.

2.9

Medical device that is a system or procedure pack under section   41BF of the Act that:

(a) is imported, supplied or manufactured by or on behalf of the Commonwealth; and

(b) is certified by the Secretary to be emergency supplies for stockpiling for use in the event of a public health emergency.

(a) The device must be imported, supplied or manufactured on or before 31   December 2010.

(b) The importation, supply or manufacture of the device must be approved in writing by the Secretary.

(c) The use and supply of the device must be in accordance with the written approval of the Secretary.

(d) Records in relation to the importation, supply or manufacture of the device must be kept in accordance with the directions of the Secretary.

(e) The disposal of any unused device must be in accordance with the directions of the Secretary.

2.10

Medical device that is a Class 1, Class 2 or Class 3 in - house IVD medical device

(a) The device must comply with the essential principles.

(b) The manufacturer of the device must apply the appropriate conformity assessment procedures at all times.

(d) The manufacturer of the device must, on request by the Secretary, provide the following information within 20 working days of receiving the request:

(i) whether the device complies with the essential principles;

(ii) whether the conformity assessment procedures have been applied to the device;

(iii) whether the device complies with every requirement (if any) relating to advertising applicable under Part   5 - 1 of the Act or the Therapeutic Goods Regulations   1990 .

(e) The manufacturer of the device must, at all times, have available:

(i) sufficient information to substantiate that the conformity assessment procedures have been applied to the device; or

(ii) information relating to changes to the device and quality management system.

(f) The manufacturer of the device must allow an authorised person to do any of the following:

(i) enter, at any reasonable time, any premises at which the manufacturer manufactures the device;

(ii) inspect the premises and the device, and examine, take measurements of, conduct tests on or require tests to be conducted on the device or anything on those premises that relates to the device;

(iii) make any still or moving image or any recording of those premises or anything on those premises.

(g) If asked to do so by an authorised person, the manufacturer of the device must give to the person any documents relating to the device that the person requires and allow the person to copy the documents.

(h) The Secretary must not have directed that the supply of the device be stopped or should cease because the supply compromises public health and safety.

2.10A

Medical device that is a Class 4 in - house IVD medical device and that is intended by its manufacturer 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

(a) The device must comply with the essential principles.

(b) The manufacturer of the device must apply the appropriate conformity assessment procedures at all times.

(c) The manufacturer of the device must, on request by the Secretary, provide the following information within 20 working days of receiving the request:

(i) whether the device complies with the essential principles;

(ii) whether the conformity assessment procedures have been applied to the device;

(iii) whether the device complies with every requirement (if any) relating to advertising applicable under Part   5 - 1 of the Act or the Therapeutic Goods Regulations   1990 .

(d) The manufacturer of the device must, at all times, have available:

(i) sufficient information to substantiate that the conformity assessment procedures have been applied to the device; or

(ii) information relating to changes to the device and quality management system.

(e) The manufacturer of the device must allow an authorised person to do any of the following:

(i) enter, at any reasonable time, any premises at which the manufacturer manufactures the device;

(ii) inspect the premises and the device, and examine, take measurements of, conduct tests on or require tests to be conducted on the device or anything on those premises that relates to the device;

(iii) make any still or moving image or any recording of those premises or anything on those premises.

(f) If asked to do so by an authorised person, the manufacturer of the device must give to the person any documents relating to the device that the person requires and allow the person to copy the documents.

(g) The Secretary must not have directed that the supply of the device be stopped or should cease because the supply compromises public health and safety.

2.11

Unused emergency medical devices directed by the Secretary, under clause   7 of Schedule   3A, to be exported

compliance with Schedule   3A, as if section   41GY of the Act applies to the devices

2.12

Custom - made medical device that is manufactured in Australia

(a) The manufacturer of the device must, at all times, have available:

(i) sufficient information to substantiate that the conformity assessment procedures have been applied to the device; or

(ii) information relating to the design and manufacture of the device and to any changes to the device.

(b) The manufacturer of the device must allow an authorised person to do any of the following:

(i) enter, at any reasonable time, any premises (including premises outside Australia) at which the manufacturer or any other person deals with the device;

(ii) inspect those premises;

(iii) if the device is on those premises--inspect the device and examine, take measurements of, conduct tests on or require tests to be conducted on the device;

(iv) inspect any thing on those premises that relates to the device and examine, take measurements of, conduct tests on, require tests to be conducted on or take samples of any such thing;

(v) make any still or moving image or any recording of those premises or any thing on those premises.

(c) If asked to do so by an authorised person, the manufacturer of the device must produce to the authorised person any documents relating to the device that the authorised person requires and allow the authorised person to copy the documents.

(d) The manufacturer of the device must, on request from the Secretary, give the Secretary a copy of the health professional's request for the device within the period requested by the Secretary (which must be at least 10 working days starting on the day on which the Secretary's request is made).

2.13

Custom - made medical device that is manufactured outside Australia

(a) The sponsor must have procedures in place to ensure that the manufacturer of the device, at all times, has available:

(i) sufficient information to substantiate that the conformity assessment procedures have been applied to the device; or

(ii) information relating to the design and manufacture of the device and to any changes to the device.

(b) The sponsor must have procedures in place to ensure that the manufacturer of the device allows an authorised person to do any of the following:

(i) enter, at any reasonable time, any premises at which the manufacturer or any other person deals with the device;

(ii) inspect those premises;

(iii) if the device is on those premises--inspect the device and examine, take measurements of, conduct tests on or require tests to be conducted on the device;

(iv) inspect any thing on those premises that relates to the device and examine, take measurements of, conduct tests on, require tests to be conducted on or take samples of any such thing;

(v) make any still or moving image or any recording of those premises or any thing on those premises.

(c) The sponsor must have procedures in place to ensure that the manufacturer of the device, if the manufacturer is asked to do so by an authorised person, produces to the authorised person any documents relating to the device that the authorised person requires and allows the authorised person to copy the documents.

(d) The sponsor must, on request from the Secretary, give the Secretary a copy of the health professional's request for the device within the period requested by the Secretary (which must be at least 10 working days starting on the day on which the Secretary's request is made).

2.14

Patient - matched medical device

The sponsor must, before 1   November 2024, notify the Secretary in writing of each kind of patient - matched medical device that is intended to be supplied in Australia on or after 1   July 2029 and of the following:

(a) the name and address of the sponsor;

(b) the name and address of the manufacturer of that kind of medical device;

(c) the device nomenclature system code of that kind of medical device;

(d) the medical device classification of that kind of medical device;

(e) the unique product identifier given to each medical device of that kind.

2.15

Medical device that is clinical decision support system software that is:

(a) intended by its manufacturer to be for the sole purpose of providing or supporting a recommendation to a health professional about preventing, diagnosing, curing or alleviating a disease, ailment, defect or injury in persons; and

(b) not intended by its manufacturer to directly process or analyse a medical image or signal from another medical device; and

(c) not intended by its manufacturer to replace the clinical judgement of a health professional in relation to making a clinical diagnosis or decision about the treatment of patients

(a) The device must comply with the essential principles.

(b) The manufacturer of the device must apply the appropriate conformity assessment procedures at all times.

(c) The manufacturer of the device must, on request by the Secretary, provide the following information within 20 working days of receiving the request:

(i) whether the device complies with the essential principles;

(ii) whether the conformity assessment procedures have been applied to the device;

(iii) whether the device complies with every requirement (if any) relating to advertising applicable under Part   5 - 1 of the Act or the Therapeutic Goods Regulations   1990 .

(d) The manufacturer of the device must, at all times, have available:

(i) sufficient information to substantiate that the conformity assessment procedures have been applied to the device; or

(ii) information relating to changes to the device and quality management system.

(e) The manufacturer of the device must allow an authorised person to do any of the following:

(i) enter, at any reasonable time, any premises at which the manufacturer manufactures the device;

(ii) inspect the premises and the device, and examine, conduct tests on or require tests to be conducted on the device or anything on those premises that relates to the device;

(iii) make any still or moving image or any recording of those premises or anything on those premises.

(f) If asked to do so by an authorised person, the manufacturer of the device must give to the person any documents relating to the device that the person requires and allow the person to copy the documents.

(g) The Secretary must not have directed that the supply of the device be stopped or should cease because the supply compromises public health and safety.

(h) The manufacturer or sponsor of the device must provide information of a kind mentioned in subsection   41MP(2) or 41MPA(2) of the Act to the Secretary within the following periods:

(i) if the information relates to an event or other occurrence that represents a serious threat to public health--48 hours after the manufacturer or sponsor becomes aware of the event or occurrence;

(ii) if the information relates to an event or other occurrence that led to the death, or a serious deterioration in the state of health, of a patient, a user of the device, or another person--10 days after the manufacturer or sponsor becomes aware of the event or occurrence;

(iii) if the information relates to an event or other occurrence a recurrence of which might lead to the death, or a serious deterioration in the state of health, of a patient, a user of the device, or another person--30 days after the manufacturer or sponsor becomes aware of the event or occurrence;

(iv) in any other case--60 days after the manufacturer or sponsor becomes aware of the information.

(i) The sponsor of the device must notify the Secretary, using a form approved in writing by the Secretary:

(i) as far as it is reasonably practicable, of any supply of the device by or on behalf of the sponsor that occurred before 25   February 2021, being a notification within 60 working days (or such longer period as is agreed to by the Secretary) of that day; and

(ii) of any importation or supply of the device by or on behalf of the sponsor on or after 25   February 2021, being a notification within 20 working days (or such longer period as is agreed to by the Secretary) of the importation or supply.

2.16

Medical device that is a surgical loan kit, where:

(a) the kit is intended by its manufacturer to be supplied to hospitals in Australia; and

(b) the kit is intended by its manufacturer to be used in a surgical procedure; and

(c) the kit contains 2 or more reusable surgical instruments and the only other therapeutic goods (if any) in the kit are either or both of the following:

(i) one or more implantable medical devices;

(ii) one or more Class I, Class IIa, Class IIb or Class III medical devices; and

(d) each of the medical devices in the kit is included in the Register

(a) The device must comply with the essential principles.

(b) The manufacturer of the device must apply the appropriate conformity assessment procedures (if any) at all times.

(c) The manufacturer of the device must, on request by the Secretary, provide the following information within 20 working days of receiving the request:

(i) whether the device complies with the essential principles;

(ii) whether the conformity assessment procedures (if any) have been applied to the device;

(iii) whether the device complies with every requirement (if any) relating to advertising applicable under Part   5 - 1 of the Act or the Therapeutic Goods Regulations   1990 .

(d) The manufacturer of the device must, at all times, have available sufficient information to substantiate that the conformity assessment procedures (if any) have been applied to the device.

(e) The manufacturer of the device must allow an authorised person to do any of the following:

(i) enter, at any reasonable time, any premises at which the manufacturer manufactures the device;

(ii) inspect the premises and the device, and examine, take measurements of, conduct tests on or require tests to be conducted on the device or anything on those premises that relates to the device;

(iii) make any still or moving image or any recording of those premises or anything on those premises.

(f) If asked to do so by an authorised person, the manufacturer of the device must give to the person any documents relating to the device that the person requires and allow the person to copy the documents.

(g) The Secretary must not have directed that the supply of the device be stopped or should cease because the supply compromises public health and safety.

(h) The manufacturer or sponsor of the device must provide information of a kind mentioned in subsection   41MP(2) or 41MPA(2) of the Act to the Secretary within the following periods:

(i) if the information relates to an event or other occurrence that represents a serious threat to public health--48 hours after the manufacturer or sponsor becomes aware of the event or occurrence;

(ii) if the information relates to an event or other occurrence that led to the death, or a serious deterioration in the state of health, of a patient, a user of the device, or another person--10 days after the manufacturer or sponsor becomes aware of the event or occurrence;

(iii) if the information relates to an event or other occurrence a recurrence of which might lead to the death, or a serious deterioration in the state of health, of a patient, a user of the device, or another person--30 days after the manufacturer or sponsor becomes aware of the event or occurrence;

(iv) in any other case--60 days after the manufacturer or sponsor becomes aware of the information.

(i) The person under whose name the device is or is to be supplied must keep records relating to the supply of the device by or on behalf of the person.

(j) The person under whose name the device is or is to be supplied must, on request by the Secretary, provide to the Secretary those records within 20 working days of receiving the request or a longer period agreed to by the Secretary.

2.17

Medical device that is:

(a) a therapeutic vaping device; or

(b) a therapeutic vaping device accessory

(a) The sponsor must give the Secretary a notice (the sponsor notice ), in a form approved in writing by the Secretary, stating that:

(i) the device is intended, by the person under whose name the device is or is to be supplied, only to administer or contain a therapeutic vaping substance whose only indications are use for smoking cessation or the management of nicotine dependence; and

(ii) the device complies with the essential principles, or is imported or supplied (as the case may be) with the consent of the Secretary under section   41MA or 41MAA of the Act.

(b) The sponsor notice must be given as follows:

(i) for a device imported into Australia on or after 1   March 2024--before the device is imported;

(ii) for a device imported into Australia before 1   March 2024--before the earlier of the time the device is supplied to the ultimate consumer and the end of the period of 2 months beginning on the day Schedule   1 to the Therapeutic Goods Legislation Amendment (Vaping Reforms) Regulations   2024 commences;

(iii) for a device manufactured in Australia on or after 1   March 2024--before the device is first supplied in Australia;

(iv) for a device manufactured in Australia before 1   March 2024--before the earlier of the time the device is supplied to the ultimate consumer and the end of the period of 2 months beginning on the day Schedule   1 to the Therapeutic Goods Legislation Amendment (Vaping Reforms) Regulations   2024 commences.

(c) The sponsor holds information or evidence to support the statements made in the sponsor notice.

(d) Neither of the statements made in the sponsor notice is incorrect.

(e) The device is not the subject of a determination, by the Secretary and published on the Department's website, that the supply of the device be stopped or should cease because:

(i) the Secretary is satisfied that the supply compromises public health and safety; or

(ii) the Secretary is satisfied that the device does not comply with the essential principles.

(f) The sponsor must:

(i) if requested by the Secretary, give the Secretary the information or evidence referred to in paragraph   (c); and

(ii) do so within the period requested by the Secretary (which must be at least 5 working days starting on the day on which the Secretary's request is made).

(fa) The sponsor must:

(i) if requested by the Secretary, give the Secretary a reasonable number of samples of the device; and

(ii) do so within the period requested by the Secretary (which must be at least 5 working days starting on the day on which the Secretary's request is made).

(fb) The sponsor must allow an authorised officer:

(i) to enter, at any reasonable time, any premises (including premises outside Australia) at which the sponsor or any other person deals with the device; and

(ii) while on those premises, to inspect those premises and the device and to examine, take measurements of, conduct tests on, require tests to be conducted on or take samples of the device or any thing on those premises that relates to the device; and

(iii) while on those premises, to make any still or moving image or any recording of those premises or any thing on those premises.

(fc) The sponsor must, if requested to do so by an authorised officer, produce to the authorised officer such documents relating to the device as the authorised officer requires and allow the authorised officer to copy the documents.

(fd) If the sponsor is not the manufacturer of the device, the sponsor must have procedures in place to ensure that the manufacturer of the device allows an authorised officer:

(i) to enter, at any reasonable time, any premises (including premises outside Australia) at which the manufacturer or any other person deals with the device; and

(ii) while on those premises, to inspect those premises and the device and to examine, take measurements of, conduct tests on, require tests to be conducted on or take samples of the device or any thing on those premises that relates to the device; and

(iii) while on those premises, to make any still or moving image or any recording of those premises or any thing on those premises.

(fe) If the sponsor is not the manufacturer of the device, the sponsor must have procedures in place to ensure that the manufacturer of the device, if the manufacturer is requested to do so by an authorised officer, produces to the authorised officer such documents relating to the device as the authorised officer requires and allow the authorised officer to copy the documents.

(g) The device may be supplied to a person who is not the ultimate consumer of the device only if:

(i) the person (the recipient) to whom the device is supplied is the holder of a licence in force under Part   3 - 3 of the Act that authorises a step in the manufacture of vaping goods; or

(ii) the recipient is a wholesaler, pharmacist, medical practitioner or nurse practitioner who is the holder of a licence, or is otherwise authorised, to supply one or more substances included in Schedule   3 to the current Poisons Standard under a law of the State or Territory in which the recipient carries on a business, practises or is employed; or

(iii) the Secretary has given the recipient a consent under subsection   41RC(1) of the Act to supply the device; or

(iv) in the case of a device that is covered by a determination made by the Minister under section   41R of the Act--the recipient is specified in the determination, or is included in a class of persons specified in the determination, in relation to the device.

(h) The device may be supplied to the ultimate consumer of the device only if:

(i) the device is supplied as a finished product; and

(ii) the supply is by a pharmacist, medical practitioner or nurse practitioner who is the holder of a licence, or is otherwise authorised, to supply one or more substances included in Schedule   3 to the current Poisons Standard under a law of the State or Territory in which the recipient carries on a business, practises or is employed; and

(iii) if the supply is by a person authorised as described in subparagraph   (ii), the supply is in accordance with that authorisation.

(i) The sponsor must:

(i) keep records relating to the source and supply of the device; and

(ii) if requested by the Secretary, give the records to the Secretary within the period requested by the Secretary (which must be at least 5 working days starting on the day on which the Secretary's request is made).

(j) The sponsor must provide information of a kind mentioned in subsection   41MP(2) or 41MPA(2) of the Act relating to the device to the Secretary within the following periods:

(i) if the information relates to an event or other occurrence that represents a serious threat to public health--48 hours after the sponsor becomes aware of the event or occurrence;

(ii) if the information relates to an event or other occurrence that led to the death, or a serious deterioration in the state of health, of a patient, a user of the device, or another person--10 days after the sponsor becomes aware of the event or occurrence;

(iii) if the information relates to an event or other occurrence a recurrence of which might lead to the death, or a serious deterioration in the state of health, of a patient, a user of the device, or another person--30 days after the sponsor becomes aware of the event or occurrence;

(iv) in any other case--60 days after the sponsor becomes aware of the information.

2.18

Medical device imported into Australia, if the medical device is a component or article imported for use in the manufacture of:

(a) a therapeutic vaping device; or

(b) a therapeutic vaping device accessory; or

(c) a therapeutic cannabis vaping good

(a) The sponsor must give the Secretary a notice (the sponsor notice ), in a form approved in writing by the Secretary, stating that the device is for use in the manufacture, in accordance with the requirements of the Act, of a therapeutic vaping device, a therapeutic vaping device accessory or a therapeutic cannabis vaping good by a manufacturer that holds all relevant licences or approvals (however described) required under the law of the State or Territory in which the manufacture is to occur.

(b) The sponsor notice must be given before importing the device.

(ba) The sponsor must:

(i) if requested by the Secretary, give the Secretary a reasonable number of samples of the device; and

(ii) do so within the period requested by the Secretary (which must be at least 5 working days starting on the day on which the Secretary's request is made).

(c) The device may be supplied only for use in manufacture as referred to in paragraph   (a).