Referring to Regulation 5, after 5 years, medical device establishments will have to reapply for their medical device establishment licenses (which could be as early as 2022). SAHPRA accepted quality management systems that were not certified by independent auditors as a transitional measure when the regulations were first introduced. Since then they have indicated that the industry has 5 years to get certification to the standard ISO13485. They have no issued any formal notifications to this end and as such SAMED has asked for clarification and an extension.
Related Knowledge Base Posts
- 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?
- Are IVDs regulated in Mozambique?
- Who must I contact at SAHPRA if I have port health issues?
- Who must I contact at SAHPRA to report an adverse event?
- Who must I contact at SAHPRA to report poor quality or counterfeit medical devices?
- Who must I contact at SAHPRA regarding new licence applications
- Does SAHPRA allow re-sterilisation of a medical device?
- Is registration for medical devices required in Cameroon and what it would entail for registering of a medical device in this country?
