Medicines and Related Substances Control Act, 1965 (Act No. 101 of 1965)RegulationsRegulations relating to Medical Devices and In Vitro Diagnostic Medical Devices (IVDs)10. Amendment to medical device and IVD register |
| (1) | A holder of a certificate of registration may submit to the Registrar an application on a form, as determined by the Council, to amend an entry made in the medical devices or IVDs register with regard to a particular medical device or IVD. |
| (2) | The application referred to in subregulation (1) must be accompanied by the prescribed fee, and must contain the following information: |
| (a) | The registration number of the medical device or IVD; |
| (b) | the name and business address of the holder of a certificate of registration and the authorised representative; |
| (c) | a declaration by the authorised representative that the information furnished is complete and accurate; |
| (d) | the details of the amendment applied for; |
| (e) | the manufacturer licence number of the manufacturer or the distributor licence number of the distributor; and |
| (f) | any other information determined by the Council. |