Commonwealth Numbered Regulations

THERAPEUTIC GOODS LEGISLATION AMENDMENT (2017 MEASURES NO. 1) REGULATIONS 2017 (F2017L00853) - SCHEDULE 8

Therapeutic Goods (Medical Devices) Regulations 2002

1  At the end of Division 5.2 of Part 5

Add:

5.9   Conditions applying automatically--storage and transport of medical devices (Act s 41FN)

                   For the purposes of subsection 41FN(5A) of the Act, the person in relation to whom a kind of medical device is included in the Register must ensure that, while the person has control over a device of that kind, the device is stored and transported in accordance with the manufacturer's instructions for use of the device and any other information provided with the device by the manufacturer.

5.10   Conditions applying automatically--record-keeping (Act s 41FN)

             (1)  For the purposes of subsection 41FN(5A) of the Act, the person in relation to whom a kind of medical device is included in the Register must:

                     (a)  create a record of information of a kind referred to in regulation 5.8 that relates to that kind of device as soon as practicable after the person becomes aware of the information; and

                     (b)  create a record of information in relation to the distribution by the person of each device of that kind as soon as practicable after the distribution.

             (2)  A record created under subregulation (1) must be kept:

                     (a)  for 10 years if the record relates to one of the following kinds of device:

                              (i)  a Class AIMD medical device;

                             (ii)  a Class III medical device;

                            (iii)  a Class IIb medical device that is an implantable medical device;

                            (iv)  a Class 4 IVD medical device; or

                     (b)  for 5 years if the record relates to any other kind of device.

5.11   Conditions applying automatically--reporting (Act s 41FN)

             (1)  This regulation applies in relation to the following kinds of medical devices:

                     (a)  a Class AIMD medical device;

                     (b)  a Class III medical device;

                     (c)  a Class IIb medical device that is an implantable medical device;

                     (d)  a Class 4 IVD medical device.

             (2)  For the purposes of subsection 41FN(5A) of the Act, the person in relation to whom a medical device of that kind is included in the Register must, before 1 October after each reporting period for that kind of device, give the Secretary a report about that kind of device for the reporting period.

             (3)  The report must include the following:

                     (a)  if no device of that kind was supplied in Australia or a foreign country during the reporting period--a statement to that effect;

                     (b)  if the person became aware during the reporting period of information of a kind referred to in regulation 5.8 that relates to that kind of device--that information;

                     (c)  if the person did not become aware during the reporting period of information of a kind referred to in regulation 5.8 that relates to that kind of device--a statement to that effect.

             (4)  For the purposes of this regulation, each of the following is a reporting period for a kind of medical device:

                     (a)  the period:

                              (i)  beginning on the day when that kind of device is included in the Register; and

                             (ii)  ending at the end of the next 30 June;

                     (b)  each of the next 2 financial years.

5.12   Conditions applying automatically--notification of information relating to certain IVD medical devices (Act s 41FN)

             (1)  This regulation applies in relation to a kind of medical device specified in paragraph 5.3(1)(j).

             (2)  For t he purposes of subsection 41FN(5A) of the Act, the person in relation to whom a medical device of that kind is included in the Register must give the Secretary a written notice if:

                     (a)  the person intends to import, supply or export a medical device of that kind; and

                     (b)  either of the following is not included in the Register:

                              (i)  the product name of the device;

                             (ii)  information in relation to the manufacturer's intended purpose of the device.

             (3)  The notice must:

                     (a)  specify the information mentioned in paragraph (2)(b) that is not included in the Register; and

                     (b)  be given to the Secretary no later than 20 business days before the intended import, supply or export of the device.

2  Regulation 10.6A

Omit "paragraph 57(9)(b)", substitute "subsection 57(9)".

3  Paragraph 10.6A(c)

Omit "Regulatory Services Group", substitute "Health Products Regulation Group".

4  Part 1 of Schedule 4 (table item 1.3, column headed "Kinds of medical devices", paragraph (d))

Omit "or laboratory testing procedures", substitute ", evaluation or laboratory testing procedures".

5  Part 1 of Schedule 4 (at the end of table item 1.3, column headed "Kinds of medical devices")

Add:

(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)

6  Part 1 of Schedule 5 (before table item 1.7)

Insert:

Therapeutic Goods Regulations 1990

7  Subregulation 46A(2)

Omit "paragraph 57(8)(b)", substitute "subsection 57(8)".

8  Clause 3 of Schedule 9 (before table item 6C)

Insert:

9  Part 2 of Schedule 9A (before table item 17)

Insert: