Medicines and Related Substances Control Act, 1965 (Act No. 101 of 1965)RegulationsRegulations relating to Medical Devices and In Vitro Diagnostic Medical Devices (IVDs)20. Compliance with requirements |
| (1) | A medical device or IVD must conform to the standards and specifications which were furnished to the Council on the form referred to in regulation 8 and which form has been accepted by Council in respect of the medical device or IVD. |
| (2) | A medical device or IVD must conform to the Essential Principles furnished to the Council with a declaration of conformity referred to in regulation 8(7). |
| (3) | A proposed deviation from accepted standards and specifications referred to in subregulations (1) and (2), must be submitted to the Council for prior approval. |