Module 19: Regulation of In Vitro Diagnostic Medical Devices

20/04/2023

• 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.

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The big 5 regulated Markets-Japan

 File requirements for IVDs

 1 Product name and generic name

 2 Indication (sample type, parameter, and quantitative/qualitative)

 3 Shape, structure and principle

 4 Name and amount (range of concentration) of the ingredients which are involved in the reaction (rare reagents like antibody)

 5 Specification of the final products (Quality control criteria,

 including Information of primary standard or QC materials)

 6 Usage (Specimens, reagent preparation, assay procedures)

 7 Manufacturing process and name of manufacturing site

 8 Storage conditions and shelf life

 9 Registered information of design owner (only Class II and III), manufacturing site and marketing approval holder

 10 Information of QMS compliance for design owner and manufacturing site (only Class II and III)

 Above information is registered. Items underlined may Japanese special requirements.

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