Singapore legislation

Regulation 15

of Health Products (Medical Devices) Regulations 2010

Regulation 15

Information to be provided with medical devices

Amended byS 318/2018 wef 01/06/2018S 318/2018 wef 01/06/2018S 318/2018 wef 01/06/2018S 318/2018 wef 01/06/2018S 318/2018 wef 01/06/2018

Subregulation 1

Amended byS 318/2018 wef 01/06/2018S 318/2018 wef 01/06/2018S 318/2018 wef 01/06/2018S 318/2018 wef 01/06/2018

For the purposes of section 18(1) of the Act, no person shall supply any medical device unless the following information accompanies the medical device when it is supplied:

(a)

the trade or brand name of the medical device;

(b)

where the medical device is supplied for use in any investigational testing, the statement “For Clinical Trial Use” or any other statement in English that conveys the same meaning;

(c)

[Deleted by S 318/2018 wef 01/06/2018](d)where the medical device is contained in a package and the contents of the package are not readily apparent, an indication of what the package contains, expressed in terms appropriate to the medical device, such as the size, net weight, length, volume or number of units;

(e)

the expiry date of the medical device, if the medical device has one, as determined by the product owner of the medical device on the basis of the component of the medical device that has the shortest projected useful life; (f)the product owner’s name or trading name, address, telephone number and electronic mail address;

(g)

an appropriate control number, such as a batch code, lot number or serial number.

Subregulation 2

Amended byS 318/2018 wef 01/06/2018

The information mentioned in paragraph (1) must be provided in the manner specified on the Authority’s website.