Health Products (Exemptions) Order 2016

No. S 536

Health Products Act

(CHAPTER 122D)

Health Products (Exemptions) Order 2016

In exercise of the powers conferred by section 70 of the Health Products Act, the Health Sciences Authority makes the following Order:

Citation and commencement

1.  This Order is the Health Products (Exemptions) Order 2016 and comes into operation on 1 November 2016.

Definitions

2.  In this Order —

“CTGT product” means a health product categorised as a cell, tissue or gene therapy product in the First Schedule to the Act;

[S 110/2021 wef 01/03/2021]

“CTGT Products Regulations” means the Health Products (Cell, Tissue and Gene Therapy Products) Regulations 2021 (G.N. No. S 104/2021);

[S 110/2021 wef 01/03/2021]

“medical device” means a health product categorised as a medical device in the First Schedule to the Act;

“therapeutic product” means a health product categorised as a therapeutic product in the First Schedule to the Act;

“Therapeutic Products Regulations” means the Health Products (Therapeutic Products) Regulations 2016 (G.N. No. S 329/2016).

Exemptions

3.—(1)  The exemptions relating to therapeutic products are set out in the First Schedule.

(2)  The exemptions relating to medical devices are set out in the Second Schedule.

(3)  The exemptions relating to CTGT products are set out in the Third Schedule.

[S 110/2021 wef 01/03/2021]

Revocation

4.  The following Orders are revoked:

(a) Health Products (Medical Devices) (Exemption) Order 2012 (G.N. No. S 170/2012);

(b) Health Products (Medical Devices) (Exemption No. 2) Order 2012 (G.N. No. S 427/2012).

Made on 27 October 2016.

KANDIAH SATKUNANANTHAM

Chairman,
Health Sciences Authority,
Singapore.

[HSA/LPPD/711:12/73-000; AG/LEGIS/SL/122D/2015/4 Vol. 1]