Medicines and Related Substances Control Act, 1965 (Act No. 101 of 1965)RegulationsRegulations relating to Medical Devices and In Vitro Diagnostic Medical Devices (IVDs)3. Importation of medical devices and IVDs into the Republic |
| (1) | A person may not import a medical device or IVD into the Republic except through one of the following ports of entry: |
| (a) | Cape Town International Airport or harbour; |
| (b) | Port Elizabeth Airport or harbour; |
| (c) | King Shaka International Airport or Durban harbour; or |
| (d) | OR Tambo International Airport. |
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| (2) | Despite subregulation 3(1), used medical devices or IVDs may be imported by a manufacturer for purposes of service, repair, refurbishing or maintenance. |
| (3) | A person may only import a medical device or IVD if that person— |
| (a) | is licensed in terms of section 22C(1)(b) of the Act to import medical devices or IVDs; and |
| (b) | in the case of unregistered medical devices or IVDs, is authorised by the Council to import the unregistered medical devices or IVDs. |