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Determinations/Health as made
This instrument amends the Therapeutic Goods (Medical Devices—Information that Must Accompany Application for Inclusion) Determination 2018 to specify that an extract from, or copy of, an entry in the Singapore Register of Health Products may accompany an application for inclusion for certain kinds of medical devices in the Australian Register of Therapeutic Goods.
Administered by: Health and Aged Care
Registered 08 Sep 2022
Tabling HistoryDate
Tabled HR23-Sep-2022
Tabled Senate26-Sep-2022
Table of contents.

Commonwealth Coat of Arms of Australia

 

Therapeutic Goods (Medical Devices—Information that Must Accompany Application for Inclusion) Amendment (Singapore) Determination 2022

I, Tracey Duffy, as delegate of the Secretary of the Department of Health, make the following determination.

Dated 30 August 2022

Tracey Duffy

First Assistant Secretary

Medical Devices and Product Quality Division

Health Products Regulation Group

Department of Health

 


Contents

1  Name........................................................................................................................................ 1

2  Commencement........................................................................................................................ 1

3  Authority.................................................................................................................................. 1

4  Schedules................................................................................................................................. 1

Schedule 1—Amendments                                                                                           2

Therapeutic Goods (Medical Devices—Information that Must Accompany Application for Inclusion) Determination 2018                                                                                                                                                         2

 

 


1  Name

                   This instrument is the Therapeutic Goods (Medical Devices—Information that Must Accompany Application for Inclusion) Amendment (Singapore) Determination 2022.

2  Commencement

             (1)  Each provision of this instrument specified in column 1 of the table commences, or is taken to have commenced, in accordance with column 2 of the table. Any other statement in column 2 has effect according to its terms.

 

Commencement information

Column 1

Column 2

Column 3

Provisions

Commencement

Date/Details

1.  The whole of this instrument

At the same time as the Therapeutic Goods (Overseas Regulators) Amendment (Singapore) Determination 2022 commences.

However, this instrument does not commence at all if the Therapeutic Goods (Overseas Regulators) Amendment (Singapore) Determination 2022 does not commence.

 

Note:          This table relates only to the provisions of this instrument as originally made. It will not be amended to deal with any later amendments of this instrument.

             (2)  Any information in column 3 of the table is not part of this instrument. Information may be inserted in this column, or information in it may be edited, in any published version of this instrument.

3  Authority

                   This instrument is made under subsection 41FDB(7) of the Therapeutic Goods Act 1989.

4  Schedules

                   Each instrument that is specified in a Schedule to this instrument is amended or repealed as set out in the applicable items in the Schedule concerned, and any other item in a Schedule to this instrument has effect according to its terms.

Schedule 1Amendments

Note:       See section 4.

Therapeutic Goods (Medical Devices—Information that Must Accompany Application for Inclusion) Determination 2018

1  Section 4

Insert:

Singapore Health Products Act means the Health Products Act 2007 of Singapore as in force on 1 July 2022.

Singapore Register of Health Products means the Register of Health Products kept and maintained by the Health Sciences Authority of Singapore under section 34 of the Singapore Health Products Act.

2  Part 2 of Schedule 1 (at the end of the table)

Add:

9

Health Sciences Authority of Singapore

an extract from, or copy of, the entry in the Singapore Register of Health Products as a Class B medical device

 

3  Part 3 of Schedule 1 (at the end of the table)

Add:

12

Health Sciences Authority of Singapore

an extract from, or copy of, the entry in the Singapore Register of Health Products as a Class C medical device

 

4  Division 1 of Part 4 of Schedule 1 (at the end of the table)

Add:

13

Health Sciences Authority of Singapore

an extract from, or copy of, the entry in the Singapore Register of Health Products as a Class D medical device

 

5  Division 1 of Part 5 of Schedule 1 (at the end of the table)

Add:

13

Health Sciences Authority of Singapore

an extract from, or copy of, the entry in the Singapore Register of Health Products as a Class D medical device

 

6  Part 1 of Schedule 2 (at the end of the table)

Add:

9

Health Sciences Authority of Singapore

an extract from, or copy of, the entry in the Singapore Register of Health Products as a Class B IVD

 

7  Part 2 of Schedule 2 (at the end of the table)

Add:

13

Health Sciences Authority of Singapore

an extract from, or copy of, the entry in the Singapore Register of Health Products as a Class C IVD