Module 19: Regulation of In Vitro Diagnostic Medical Devices

20/04/2023

The big regulated Markets -China

 Registration license is valid for 5 years  Class I: Registration –> Put on regulator’s Record, Permanently. Simplest process  Class II and III require a submission to the authorities  “Product technical requirement” -- Class III IVD should present the requirement on main raw material, production technology and semi-finished product. Review time extended for Class III products  Renew -> continue registration, license number will not change  Class 2 approx. 30K Euro, Class 3 approx. 40K Euro plus 5K Euro renewal

The Organisation for Professionals in Regulatory Affairs

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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

The Organisation for Professionals in Regulatory Affairs

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