What are the ISO 13485 and conformity assessment bodies criteria for licence renewal?

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.

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