Snapshot

The IVD Registration (Japan) pathway has been developed by the of Japan.

This pathway can be used where Under Japan's Pharmaceutical and Medical Devices Act (PMDA/PAL Article 2-14), in vitro diagnostics (IVDs) are defined as drugs or medical devices used exclusively for disease diagnosis that are not applied directly to the body, as well as companion diagnostics indispensable for enhancing the safety or efficacy of specific drugs (excluding general diagnostic products). Japan classifies IVDs into three risk tiers—Class I (simple self-checks using standard reference materials), Class II (general test reagents/devices not falling under Class I or III), and Class III (high-risk diagnostics linked to life support or novel measurement parameters)—each requiring distinct submission dossiers: Class I requires a simple notification, Class II demands proof of conformity to certification standards and essential requirements, and Class III necessitates comprehensive technical documentation including clinical study results, stability, manufacturing methods, and risk analysis. To navigate this pathway, the Pharmaceuticals and Medical Devices Agency (PMDA) offers formal two-hour, face-to-face consultations (covering pre-development, quality, clinical evaluation, and application procedures for a fee of 1,594,700 JPY, booked roughly two months in advance via request form) alongside pilot pre-evaluation reviews. Requirements for labeling: must be indicated on immediate container or wrapper of a IVD. Name and address of a licensed marketing approval holder Name of medical device Production number or code For a medical device designated by the Minister, the contents, including weight, volume or number etc. For a medical device for which the Standards are specified to be indicated on the immediate container or wrapper For a medical device designated by the Minister, its expiry date Any other items specified by the MHLW.

This pathway accelerates the regulatory review process.

It is an abridged review (a reliance pathway).

Target time assessment is Class III (Review by the authorities): 6 months Class II (Investigation by the third bodies): depend on third-party certification bodies No registration Validity end and renewal fee for registered (obtained marketing approval/certification/notification) products is none..