Health Products (Import, Wholesale and Supply of Medical Devices — Exemption) Order 2020

No. S 78

Health Products Act

(CHAPTER 122D)

Health Products (Import, Wholesale
and Supply of Medical Devices —
Exemption) Order 2020

In exercise of the powers conferred by section 70(1) of the Health Products Act, the Health Sciences Authority makes the following Order:

Citation

1. This Order is the Health Products (Import, Wholesale and Supply of Medical Devices — Exemption) Order 2020.

Definition

2. In this Order, “specified medical device” means any of the following medical devices:

(a)	a particulate respirator;
(b)	any protective gear;
(c)	a surgical mask;
(d)	a thermometer for measuring human body temperature.

Exemption in relation to import

3.—(1) Without affecting regulation 4A, 4B or 4C of the Health Products (Medical Devices) Regulations 2010 (G.N. No. S 436/2010) and subject to sub-paragraph (2), section 13(1) of the Act and regulation 34(1)(d) of the Health Products (Medical Devices) Regulations 2010 do not apply to a person in relation to the import by the person of any specified medical device.

(2) Sub-paragraph (1) applies in relation to a specified medical device only if the person importing the specified medical device informs the Authority in writing of the intended import at least 24 hours before the specified medical device is imported.

Exemption in relation to wholesale

4. Section 14(1) of the Act does not apply to a person in relation to the supply by wholesale by the person of any specified medical device.

Exemption in relation to supply

5. Section 15(1) of the Act does not apply to a person in relation to the supply by the person of any specified medical device.

Made on 31 January 2020.

KANDIAH SATKUNANANTHAM

Chairman,
Health Sciences Authority,
Singapore.

[HSA/Legal/711:13/04-000; AG/LEGIS/SL/122D/2020/3 Vol. 1]

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