Module 19: Regulation of In Vitro Diagnostic Medical Devices

20/04/2023

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.

The Organisation for Professionals in Regulatory Affairs

11

The big regulated Markets -Japan

CDx

•

– Companion Diagnostics (CDx) are governed under the Drug Law in Japan (PMDA)

– Class III, require Ministerial Approval route

– Need external clinical studies (need Japanese specimen data; data from clinical study conducted in foreign countries is acceptable)

– In general, CDx test are given priority review by PMDA for co-development of Rx/CDx (9-12 months)

– According to MHLW Notification on July 2013, simultaneous approval of CDx and the Drug is required.

– For simultaneous approval, the CDx dossier shall be submitted at the same time or if not possible, within 1 month of the NDA in principle. Clinical Performance Data;

– CDx submission; CDx (or Final Prototype CDx) should be used as Clinical Trial Assay (CTA) for the patient selection in Drug Clinical Trial and the diagnostics data and the clinical outcome from the clinical trial can only be used for CDx registration.

Other issues

•

–

Stability must be real time at approval

The Organisation for Professionals in Regulatory Affairs

12

6