Statistics Act, 1999
R 385
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. |
