Module 19 2021

01/06/2021

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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