Health Products (Medical Devices) Regulations 2007

No. S 563

Health Products Act 2007

Act 15 of 2007

Health Products (Medical Devices) Regulations 2007

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

PART I

PRELIMINARY

Citation and commencement

1. These Regulations may be cited as the Health Products (Medical Devices) Regulations 2007 and shall come into operation on 1st November 2007.

Definitions

2. In these Regulations, unless the context otherwise requires —

“in vitro diagnostic product” means any reagent, reagent product, calibrator, control material, kit, instrument, apparatus, equipment or system, whether used alone or in combination, that is intended by its manufacturer to be used in vitro for the examination of specimens, including blood and tissue donations, derived from the human body, solely or principally for the purpose of providing information —

(a)	concerning a physiological or pathological state;
(b)	concerning a congenital abnormality;
(c)	to determine the safety and compatibility of donations, including blood and tissue donations, with potential recipients; or
(d)	to monitor therapeutic measures,

and includes a specimen receptacle but not a product for general laboratory use, unless that product, in view of its characteristics, is specifically intended by its manufacturer to be used for in vitro diagnostic examination;

“medical device” means a medical device as described in the First Schedule to the Act.

Application

3. These Regulations shall apply to any in vitro diagnostic product that is a drug or that contains a drug, as if the product were itself an in vitro diagnostic medical device.

Made this 19th day of October 2007.

EDISON LIU

Chairman,
Health Sciences Authority,
Singapore.

[HSA(HPRG) 401:04/01; AG/LEG/SL/122D/2007/1 Vol. 1]

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

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