The Medicines Control Council (MCC) is the authority responsible for medical device vigilance and quality control and controls all manufacturing, importation and distribution of medical devices and IVDs based on the amended Medicines and Related Substances Act 101 of 1965. The South African medical device classification system depends on the risk of the device and is based on the GHTF-system where devices are classified from Class A to Class D where Class A is low risk and Class D is high risk device. Class A devices are exempt from registration, when manufacturing or importing a Class B, C or D device or IVD, the manufacturer should possess at least one pre-market approval from the following authorities: Australian, Brazilian, Canadian, European, Japanese, or American.
The license to manufacture, import, export or distribute will be valid for a period of five years.
Local license holder
Companies without an establishment in South Africa are required to appoint a local authorized representative with the knowledge and responsibility to ensure that the correct procedures are followed. This authorized representative, a natural person residing in South Africa, needs to have a written mandate from the foreign manufacturer to be able to act on their behalf.
The language of the submission files shall be in English, if originals are in another language a translation should be added. Minimum information should be in English like for example product description and intended use.