Module 19: Regulation of In Vitro Diagnostic Medical Devices

13/04/2023

Other Regulators

 Not a regulator, but WHO Prequalification is becoming a requirement for many previously unregulated markets  Focus on key products and diseases such as HIV/Malaria/STD  RCP holds but talk to them first  Require site audit and established QMS  Changes must be communicated and agreed  Assessment and maintenance can be large amount of work  Approval (WHO Pre-qualification) is becoming a requirement in many previously unregulated markets

The Organisation for Professionals in Regulatory Affairs

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What about the rest of the world?

 For the final session we will focus on requirements in other regulated markets

The Organisation for Professionals in Regulatory Affairs

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