south african medical technology industry association
advancing innovation responsibility
GO

News

---------------------------------
 
Archived News
2018 / 2017 / 2016 / 2015
04 October 2016
Medicine Control Council calls for licencing of Medical Devices and IVDs

Medical device and IVD manufacturers, importers and distributors are now required to licence their company with the MCC from 1 Aug 2016 - 28 Feb 2017. Please see below links for your information:

Please Click Here to view the following Guidelines (please go to the Medical Device and IVD section):

 16.03-Guideline for a Licence to Manufacture, Import, Export or Distribute Medical Devices and IVDs
 8.02- Medical Devices and IVDs Essential Principles of Safety & Performance showing changes
 8.05- Classification of Medical Devices and IVDs
 9.79- Medical Device Establishments: Licence Requirements (which indicates the email address that all licences must be sent to)

Please Click Here to view the Guidelines for Preparation of Site Master File for pharmaceuticals (please go to the Good Manufacturing Practices’ section)

Please Click Here and go to page two, to download the application forms for:

 6.21- Licence Application to Manufacture, Import, Distribute or Export Medical Devices
 6.22- Licence Application to Import, Distribute or Export Medical Devices

Please note we are still awaiting feedback for the wholesaler application and guidelines.