Health Products (Medical Devices for SEA Games Delegations) (Exemption) Order 2015

No. S 284

Health Products Act

(CHAPTER 122D)

Health Products
(Medical Devices for SEA Games Delegations)
(Exemption) Order 2015

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

Citation

1. This Order may be cited as the Health Products (Medical Devices for SEA Games Delegations) (Exemption) Order 2015.

Definitions

2. In this Order, unless the context otherwise requires —

“exemption period” means the period starting from 15 May 2015 and ending at 11.59 p.m. on 15 September 2015;

“medical device” means a medical device referred to in the First Schedule to the Act;

“medical professional” means a doctor or any other healthcare professional, but does not include a veterinary surgeon;

“recognised foreign country or territory” means a foreign country or territory recognised in writing before 5 June 2015 by the Singapore Sports Council as a foreign country or territory participating in the SEA Games 2015;

“SEA Games 2015” means the 28th South East Asian Games to be held in Singapore from 5 June 2015 to 16 June 2015 (both dates inclusive);

“SEA Games delegation” means a group of persons comprising athletes selected to compete at the SEA Games 2015 as representatives of a recognised foreign country or territory, and their coaches, medical professionals and other officials;

“Singapore Sports Council” means the Singapore Sports Council established under section 3 of the Singapore Sports Council Act (Cap. 305).

Exemption from requirements on import

3. A medical professional who is a member of a SEA Games delegation who, during the exemption period, imports any medical device for —

(a)	the use or intended use by the medical professional to manage or treat a condition of the medical professional arising in Singapore during the exemption period because of his or her participation as a member of that same SEA Games delegation; or
(b)	the use or intended use by any other member of that same SEA Games delegation during the exemption period,

is exempt from sections 13(1), (2), (3) and (4), 42(1) and 44(1) of the Act, if the medical professional satisfies the conditions in paragraph 5.

Exemption from requirements on supply

4. A medical professional who is a member of a SEA Games delegation who, during the exemption period, supplies any medical device imported by the medical professional under paragraph 3 to any member of that same SEA Games delegation is exempt from sections 15, 17, 18, 42(1) and 44(1) of the Act, if the medical professional satisfies the conditions in paragraph 5.

Conditions of exemptions

5. The exemptions in paragraphs 3 and 4 for a medical professional who is a member of a SEA Games delegation are subject to the following conditions:

(a)	the medical professional must, during the exemption period, maintain a list specifying the name and quantity of every medical device the medical professional imports;
(b)	the quantity of each medical device imported by the medical professional must not exceed the quantity assessed by the medical professional as necessary to manage or treat all members of that same SEA Games delegation for one month, having regard to the usage instruction recommended by the manufacturer or product owner of the medical device (if any);
(c)	no medical device imported by the medical professional may be supplied to a person who is not a member of that same SEA Games delegation;
(d)	the medical professional must, during the exemption period, ensure the proper control of the supply of every imported medical device to any member of that same SEA Games delegation and the proper safekeeping of every imported medical device;
(e)	any imported medical device unused or unconsumed at the end of the exemption period must be exported from Singapore by the medical professional not later than when the medical professional leaves Singapore or the end of the exemption period, whichever is the earlier.

Exemption from requirements on supply by export

6. A medical professional who is a member of a SEA Games delegation is exempt from section 14 of the Act when supplying any medical device by export to a party outside Singapore under paragraph 5(e).

Made on 14 May 2015.

KANDIAH SATKUNANANTHAM

Chairman,
Health Sciences Authority,
Singapore.

[HSA (HPRG) 401:04/05-000; AG/LLRD/SL/122D/2010/8 Vol. 1]

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