MEDICAL DEVICE ESTABLISHMENT LICENCING

In August 2016, the Registrar of the Medicines Control Council, Dr J C Gouws, issued guidelines for A Licence to Manufacture, Import, Export or Distribute Medical Devices.

This in effect, is the first practical step towards Medical Device registration in South Africa, after the publication of amendments to the Medicines Act, brining into being the South Africa Health Products Regulatory Authority (SAHPRA), and extension of the remit of the MCC to regulate CAMS, Medical Devices and IVD’s

All companies involved in import, manufacture, distribution or export of Class B, Class C and Class D medical devices and IVD’s are required to apply for Licencing before 1 February 2017.

We provide the following project and advisory services to assist Medical Device Companies to comply with Medical Device Establish Licence Requirements and submitting Licence Applications:

  • Classification of Medical Devices according to the MCC guideline;
  • Guidance on document requirements from international suppliers;
  • Compilation of Site Master File and CTD;
  • Implementation of a Basic Quality Management System;
  • Skills transfer and training;
  • Completion of Licence Application.MBAC

For more information on how we can help your company, contact Mark Banfield on 0834072222 or via email.