Module 19: Regulation of In Vitro Diagnostic Medical Devices

20/04/2023

The big regulated Markets -Canada  Products regulated by Health Canada under Medical Devices Regulation SOR/98-282  Classification using GHTF 4 level system  CE essential requirements  Class II and above must be licensed before sale.  Manufacturers must have MDSAP certificate and Class III and IV submissions to use IMDRF MA TOC  English/French required  Takes 15-90 days  $500 to $20K depending on class.

The Organisation for Professionals in Regulatory Affairs

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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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