ISO 13485 in South Africa: Requirements for Medical Device Companies
ISO 13485 has become an important part of the regulatory framework for medical device companies…
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Manufacturer, Distributor or Wholesaler? Choosing the Right SAHPRA Licence
Choosing the correct SAHPRA medical device establishment licence starts with one question: What activities will…
SAHPRA Authorised Representative: Requirements and Responsibilities
Every medical device establishment applying for a SAHPRA manufacturer, distributor or wholesaler licence needs to…
Built for International Manufacturers: How Verion Medical Supports Medical Device Market Entry into South Africa
Entering South Africa should not require an international medical device manufacturer to rebuild its regulatory…