Module 19: Regulation of In Vitro Diagnostic Medical Devices

13/04/2023

The big regulated Markets -China

 New Registration Process -Class II & III  Registration process ● Document collection & preparation ● Type test ● Clinical trial Submission ● Technical Review ● Inspection on manufacturer ● Administrative Review ● Approval ● Inspection on overseas manufacturer and charges for registration review

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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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