Health Products (Medical Devices) (Amendment) Regulations 2022

No. S 456

Health Products Act 2007

Health Products
(Medical Devices) (Amendment)
Regulations 2022

In exercise of the powers conferred by sections 71 and 72 of the Health Products Act 2007, the Health Sciences Authority, with the approval of the Minister for Health, makes the following Regulations:

Citation and commencement

1. These Regulations are the Health Products (Medical Devices) (Amendment) Regulations 2022 and come into operation on 1 July 2022.

Amendment of regulation 2

2. In regulation 2 of the Health Products (Medical Devices) Regulations 2010 (G.N. No. S 436/2010) (called in these Regulations the principal Regulations), after the definition of “custom-made medical device”, insert —

“ “Fees Regulations” means the Health Products (Fees) Regulations 2022 (G.N. No. S 450/2022);”.

New regulation 26A

3. After regulation 26 of the principal Regulations, insert —

“Prescribed time for cancellation of registration of medical device for non‑payment of retention fee

26A. For the purposes of section 37(2) of the Act, the prescribed time is 60 days after the anniversary of the date of the registration of the medical device.”.

Deletion of Part IX

4. Delete Part IX of the principal Regulations.

Deletion of Fourth Schedule

5. Delete the Fourth Schedule to the principal Regulations.

Miscellaneous amendments

6. In the following provisions of the principal Regulations, replace “Fourth Schedule” with “Fees Regulations”:

Regulation 26(3D)

Regulation 30(1)

Regulation 48(2)(d)

Regulation 49(2)(d).

[G.N. Nos. S 542/2011; S 140/2012; S 169/2012; S 370/2012; S 426/2012; S 646/2012; S 334/2016; S 538/2016; S 444/2017; S 318/2018; S 319/2018; S 90/2019; S 968/2020; S 111/2021; S 1080/2021]

Made on 25 May 2022.

BENJAMIN ONG

Chairperson,
Health Sciences Authority,
Singapore.

[401:04/01-000; AG/LEGIS/SL/122D/2020/5 Vol. 1]

(To be presented to Parliament under section 72(5) of the Health Products Act 2007).

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