Singapore legislation
Regulation 17
Regulation 17
Substantiation of assertions of uniqueness and prominence in presentations
Subregulation 1
For the purposes of section 18(1) of the Act, where the presentation of a medical device includes any trade description containing 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 —
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
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.