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Strategic Healthcare Solutions

News Posts

  • Sep 5, 2016
Version 1.1 of the licensing application forms:

6.21 Licence application to manufacture, import, distribute or export a medical device and 6.22 Licence application to import, distribute or export medical devices is now available at mccza.com

  • Aug 30, 2016
Medical Devices & IVDs Licensing

The MCC has published the guideline for Licensing to import, manufacture, distribute and export Medical Devices and IVDs. There are two application forms – the choice of which depends on the activities which take place in South Africa. Review of the definition of “manufacturing” is particularly important when making this decision.

The guidelines for the “8.02 Essential Principles of Safety and Performance of Medical Devices and IVDs” and the “8.05 Classification of Medical Devices and IVDs” are also available on the MCC website.