Commonwealth Numbered Regulations

THERAPEUTIC GOODS LEGISLATION AMENDMENT (2020 MEASURES NO. 1) REGULATIONS 2020 (F2020L00946) - SCHEDULE 3

Therapeutic Goods (Medical Devices) Regulations 2002

1  Subregulation 5.7(1)

After "subsection 41MP(2)", insert "or 41MPA(2)".

2  At the end of subregulation 5.7(1)

Add:

            ; and (d)  in any other case--60 days after the person becomes aware of the information.

3  After regulation 10.4

Insert:

10.4AA   Civil penalty--period for notifying adverse events

                   For the purposes of paragraph 41MPA(1)(c) of the Act, the period for giving information of a kind mentioned in subsection 41MPA(2) of the Act is the relevant period specified in regulation 5.7.

4  Subclause 1.4(3) of Schedule 3 (note)

Omit "section 41MP", substitute "sections 41MP and 41MPA".

5  Subclause 3.4(2) of Schedule 3 (note)

Omit "section 41MP", substitute "sections 41MP and 41MPA".

6  Subclause 4.4(3) of Schedule 3 (note)

Omit "section 41MP", substitute "sections 41MP and 41MPA".

7  Subclause 5.4(3) of Schedule 3 (note)

Omit "section 41MP", substitute "sections 41MP and 41MPA".

8  Subclause 6.5(2) of Schedule 3 (note)

Omit "section 41MP", substitute "sections 41MP and 41MPA".

9  Subclause 7.5(4) of Schedule 3 (note)

Omit "section 41MP", substitute "sections 41MP and 41MPA".