Medicines and Related Substances Control Act, 1965 (Act No. 101 of 1965)RegulationsRegulations relating to Medical Devices and In Vitro Diagnostic Medical Devices (IVDs)18. Investigation |
| (1) | The Council may conduct an investigation with regard to a medical device or IVD, its manufacturer, distributor or wholesaler if— |
| (a) | the medical device or IVD is recalled in South Africa or any other country; |
| (b) | a medical device or IVD adverse event is reported in South Africa or any other country; |
| (c) | the medical device or IVD is suspected or found not to comply with the requirements of the Act; |
| (d) | there is an international alert with regard to the medical device, IVD or the manufacturer of the medical device or IVD; or |
| (e) | for any other reason, the Council considers it necessary to conduct an investigation on the medical device or IVD. |