Financial Sector Regulation Act, 2017
R 385.00
Medicines and Related Substances Control Act, 1965 (Act No. 101 of 1965)RegulationsRegulations relating to Medical Devices and In Vitro Diagnostic Medical Devices (IVDs)13. Parts and components |
| (1) | A person who sells an article intended specifically to replace an identical or similar integral part or component of a medical device or IVD, that is defective or worn, in order to maintain or reestablish the function of the medical device or IVD without significantly changing its performance or safety characteristics, must— |
| (a) | ensure that the article does not adversely affect the safety and performance of the medical device or IVD; and |
| (b) | keep substantiating evidence and on request, make the evidence available to the Council. |
| (2) | An article that is intended specifically to replace a part or component of a medical device or IVD and that significantly changes the performance or safety characteristics of the medical device or IVD is considered to be a medical device or IVD. |
