Singapore legislation

Regulation 20

of Health Products (Medical Devices) Regulations 2010

Regulation 20

Substantiation of assertions of uniqueness and prominence in advertisements

Subregulation 1

For the purposes of section 21(1) of the Act and without prejudice to regulation 19, where the advertisement of a medical device contains any statement, assertion, certification, award or feature of uniqueness or prominence differentiating the medical device from any other competing or similar medical device, the statement, assertion, certification, award or feature must be substantiated by facts or evidence.

Subregulation 2

For the purposes of paragraph (1), the facts or evidence required for substantiation include —

(a)

in relation to a certification or an award, the identity of the certifying or awarding body and the date the certification or award was granted; and

(b)

in relation to any claim of historical precedence in the use or administration of the medical device for the purpose of medical treatment, information on the outcome of that use or administration of the medical device.

Subregulation 3

Any facts or evidence referred to in paragraph (2)(a) must be indicated on the face of the advertisement.

Read in full context — Health Products (Medical Devices) Regulations 2010 →