Statistics Act, 1999
R 385
Medicines and Related Substances Control Act, 1965 (Act No. 101 of 1965)RegulationsRegulations relating to Medical Devices and In Vitro Diagnostic Medical Devices (IVDs)21. Advertising of medical devices or IVDs |
| (1) | The following requirements apply to an advertisement of a medical device or IVD: |
| (a) | Only Class A and Class B medical devices and IVDs may be advertised to the public or a lay person. |
| (b) | despite subregulation (a), male or female condoms may be advertised to the public. |
| (c) | an advertisement for a medical device or IVD may not contain a statement which deviates from, is in conflict with or goes beyond, the evidence submitted in the application for registration of the medical device or IVD with regard to its safety, quality, or performance where the evidence has been— |
| (i) | accepted by the Council in respect of the medical device or IVD; and |
| (ii) | incorporated into the approved instructions for use of the medical device or IVD. |
| (d) | a written advertisement for a medical device or IVD must contain— |
| (i) | the name of the medical device or IVD; and |
| (ii) | in the case of a registered medical device or IVD, the registration number allocated to the medical device or IVD; |
(e)
| (i) | when a Class C or Class D medical device or IVD is advertised for the first time to a prospective user, written information, which must include at least the information referred to in regulation 23 or regulation 24 as the case may be, must simultaneously be given to the person to whom the oral, electronic or printed advertisement is directed; and |
| (ii) | when the medical device or IVD is advertised on subsequent occasions, the information must be available on request. |
