Regulation 19

if the medical device is intended for direct delivery to the general public or for direct use by the general public, the advertisement shall not contain any statement concerning the intended use and efficacy of the medical device, unless —

such statement has been verified by objective evidence; and (ii)where the medical device is a registered medical device, the objective evidence mentioned in sub‑paragraph (i) has been furnished to the Authority at the time the application to register the medical device was made; and

an advertisement of a medical device —

may, in the case of a registered medical device, include —

a statement to the effect that the medical device is registered under the Act; and

the registration number assigned to the medical device by the Authority; but(ii)shall not contain any statement which expressly or implicitly suggests that the use of the medical device is promoted or endorsed by the Authority.