Module 19: Regulation of In Vitro Diagnostic Medical Devices

13/04/2023

The big regulated Markets -China  Clinical Trials of product  Clinical trial of instrument/test conducted in China is required ● *if not in exemption catalogue  Clinical trial should not be conducted until type test is passed  Qualification of clinical sites is required  Conduction of clinical trial should be reported to local Chinese FDA  Instrument Trials must comply with new device GCP, effective as of June 1, 2016. ● Specifying requirements in study procedure, documentation, management of study devices, etc. ● Data analysis should be conducted by the Statistical Department of sites or a third party

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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.

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