Medicines and Related Substances Control Act, 1965 (Act No. 101 of 1965)RegulationsRegulations relating to Medical Devices and In Vitro Diagnostic Medical Devices (IVDs)28. Transitional arrangements regarding unregistered medical devices and IVDs |
| (1) | An unregistered medical device or IVD sold in the Republic at the time of the commencement of these Regulations is, subject to regulation 8, considered to be sold legally until such time as the call-up notice period referred to in subregulation (2), for the medical device or IVD, has expired. |
| (2) | The Council must, from time to time, issue a notice in the Gazette calling for the registration of medical devices and IVDs which notice must— |
| (a) | stipulate which classes of medical devices and IVDs must be registered; and |
| (b) | provide for the conditions and time periods for the application for registration. |
| (3) | Despite subregulation (1), the Council may require a medical device or IVD to comply with the requirements that the Council may determine in order to ensure that the medical device or IVD meets the Essential Principles of safety and performance, determined by the Council. |