Module 19: Regulation of In Vitro Diagnostic Medical Devices

20/04/2023

The big 5 regulated Markets -Japan

 Pharmaceutical and Medical Device Act (PMD Act) ● Pharmaceuticals Affairs Law was revised to PMD Act on 2014/11/25. – The major changing points were;

– - To strengthen the regulation from the perspective on safety – - To designate software for medical treatment as medical device – - To set the regulation for regenerative medicine  Ministerial ordinance of PMD, Quality Management System(QMS), Good Quality Practice （ GQP), Good Vigilance Practice （ GVP) ● Must comply with QMS, GQP and GVP for all IVD and MD.  There are many guidelines, notification under these ordinance

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The big 5 regulated Markets -Japan  Japan has three product classifications:  Class III: Approval by MHLW / PMDA ● Products with high risk and a significant effect on human life ● Infectious diseases, Tumor markers, Blood typing/Cell typing, Nucleic acid of pathogen, ● New markers ● Markers beyond the approval criteria

● (These products are examined by the specialists' committee) ● HIV, HCV, HDV, HTLV, NAT, Human genetic test, New markers

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