Medicines and Related Substances Control Act, 1965 (Act No. 101 of 1965)RegulationsRegulations relating to Medical Devices and In Vitro Diagnostic Medical Devices (IVDs)8. Application for registration of a medical device or IVD |
| (1) | A person residing and doing business in the Republic may apply for the registration of a medical device or IVD. |
| (2) | An application for the registration of a medical device or IVD must include the particulars of the authorised representative in South Africa who is responsible for communication with the Council. |
| (3) | An application for the registration of a medical device or IVD must be made on the appropriate form obtainable from the Registrar and must be accompanied by— |
| (a) | the completed application form; |
| (b) | a proposed label for use on the medical device or IVD, if applicable; |
| (c) | the instructions for use of the medical device or IVD; |
| (d) | where applicable, |
| (i) | a copy of the manufacturer licence or distributor licence together with a conformity assessment certificate of a Quality Management System for the local medical device establishment, as determined by the Council; and |
| (ii) | a certified copy of the conformity assessment certificate to a quality standard, as determined by the Council, for the medical device or IVD to be registered, and which is issued by a Conformity Assessment Body; |
| (e) | any other information as the Council may determine; and |
| (f) | the application fee. |
| (4) | The information referred to in subregulation (3) must, at least, be in English. |
| (5) | The application form referred to in subregulation (3)(a) must contain at least the following information: |
| (a) | Particulars of the prospective holder of the certificate of registration: |
| (i) | Name; |
| (ii) | Business Address; |
| (iii) | Postal Address; |
| (iv) | Telephone Number; |
| (v) | Fax Number, where available; |
| (vi) | e-mail address; and |
| (vii) | contact details of the authorised representative referred to in subregulation (2). |
| (b) | Particulars of the medical device or IVD: |
| (i) | The name and group or family name, make and model, where applicable; |
| (ii) | intended purpose or use; |
| (iii) | classification and registration status in recognised authorities outside the Republic, as determined by the Council, and proposed classification in the Republic; |
| (iv) | nomenclature system code; |
| (v) | in the case of a combination device, the name and quantity of the scheduled substances or biological substances; |
| (vi) | the name and physical address of the original manufacturer; and |
| (vii) | the name and physical address of the clinical investigation sites, where applicable. |
| (6) | A medical device or IVD, in respect of which an application for registration is made, must comply with the Essential Principles for Safety and Performance of Medical Devices which include requirements for quality, safety and performance, as determined by the Council. |
| (7) | An application for registration of a medical device or IVD must be accompanied by a declaration of conformity by the authorised representative as determined by the Council. |
| (8) | An application must be made in respect of each individual medical device or IVD, or medical device or IVD group or family or modification thereof, as determined by the Council. |
| (9) | In an instance where a medical device or IVD in respect of which an application is made, is registered with a regulatory body outside the Republic, the following information in respect of the medical device or IVD must accompany the application: |
| (a) | A certified copy of the certificate of registration or premarket approval, where applicable; |
| (b) | instructions for use, where applicable; |
| (c) | conditions of registration; and |
| (d) | any other information determined by the Council. |