Each medical device establishment license requires a unique/different authorized representative
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- Does South Africa recognizes certification of medical devices approved in Australia?
- There is a local arm of a multinational that wants to know if their European principal’s QMS covers them or if they would need their own QMS as a subsidiary of the multinational. I enquired if they are subject to the principal’s QMS and they indicated that they are not as they are only the importer and do not manufacture locally but the international principal holds the ISAO13485 accreditation across its entire range of products (which makes sense because the company is ISO accredited and not the products themselves). Does the local subsidiary need to be listed on the international principal’s ISO accreditation or have its own?
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- Who must I contact at SAHPRA to report poor quality or counterfeit medical devices?
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