Module 19 2021

01/06/2021

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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