Module 19: Regulation of In Vitro Diagnostic Medical Devices

13/04/2023

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

The Organisation for Professionals in Regulatory Affairs

27

• Class II: Certification by Certification (Notified) Body

• Products with relatively small risk and a smaller effect on human life than Class III products • Autoimmune, Hormone, Biochemistry, etc. • If the product doesn't meet the certification criteria, it should be submitted PMDA for approval by MHLW. • Consumer tests (glucose, total protein and hCG) are classified as Class II. They could be certified as OTC. • Class I: Notification (Self-certification) • Products with small risk and a smaller effect on human life than Class II products • In addition, the product should be calibrated with national or international standards which designated by MHLW. • HbA1c, Cholesterol, Electrolyte, etc.

The Organisation for Professionals in Regulatory Affairs

28