Module 19: Regulation of In Vitro Diagnostic Medical Devices

13/04/2023

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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The big 5 regulated Markets -Japan  Dossier Structure (for attachment of Class II and III) ● 1 Origin, development process, status overseas ● 2 Shape, structure, principle , assay procedures ● 3 Name, amount (concentration) and TS/QS of the components which are involved in the reaction. (Antibody, Conjugate) ● 4 Specification of the final product (Quality control criteria) ● 5 Measurement range(Quantitative), detection limit (Qualitative) ● 6 Standard substance (Calibration) ● 7 Stability ● 8 Compliance to essential requirements ● 9 Linearity and spike test (Quantitative) ● 10 Study to determine assay procedures ● 11 Information on the sample ● 12 Correlation with 2 registered products (predicates) in Japan ● 13 Performance on seroconversion panel ● 14 Risk analysis ● 15 Manufacturing process ● 16 Clinical evaluation (new IVD item) ● 17 Package insert (Draft)

 Bold documents are essential in all cases. Other information will be attached according to the sub-level in Class III.

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