Module 19: Regulation of In Vitro Diagnostic Medical Devices

20/04/2023

The big regulated Markets -China

 China legislation is multi-level for IVDs ● Administrative Regulations – Supervision and Administration Regulation of Medical Device State Council Decree 650 – Major change from 1 st June 2014 ● Department Regulation – Provisions for Medical Device Registration CFDA Order 4 – Provisions for IVD Registration CFDA Order 5 ● Normative Documents – Announcement on requirement of registration document and format of approved certificate for medical device

The Organisation for Professionals in Regulatory Affairs

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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

The Organisation for Professionals in Regulatory Affairs

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