PMDA Japan Medical Device Registration & Approval

Japan's medical device system separates scientific review from the legal approval decision. The Pharmaceuticals and Medical Devices Agency (PMDA) performs scientific reviews, consultations, inspections, and post-market safety work, while the Ministry of Health, Labour and Welfare (MHLW) makes approval decisions. Some designated devices are certified by Registered Certification Bodies instead of receiving an MHLW approval. PMDA describes these routes in its official medical device review guidance.

Japan classification and authorization routes

Devices are classified as Class I, II, III, or IV according to risk and assigned a Japanese Medical Device Nomenclature (JMDN) code. Class I devices generally follow a notification route. Many designated Class II and some Class III devices can use third-party certification when an applicable certification standard exists. Other Class II and III devices, and Class IV devices, generally require MHLW approval following PMDA review.

The route therefore cannot be selected from class alone. The JMDN code, general or specified control category, certification standard, novelty, intended use, and claims all matter. Foreign classifications and approvals can support the evidence package but do not replace the Japan-specific route analysis.

MAH and DMAH requirements

A product must be placed on the Japanese market through a licensed Marketing Authorization Holder (MAH). A foreign manufacturer without its own Japanese MAH structure may appoint a Designated Marketing Authorization Holder (DMAH). Generic handler titles are not the correct regulatory role; use MAH or DMAH as applicable.

The MAH or DMAH holds significant quality, safety, vigilance, and authority-communication responsibilities. Agreements should cover dossier access, consultation strategy, change control, renewal or maintenance, complaints, adverse-event reporting, recalls, and transfer planning.

Evidence, QMS, and lifecycle

A submission typically includes the intended use and JMDN basis, device description, risk management, verification and validation, clinical evidence where needed, manufacturing-site information, quality-system evidence, and Japanese labeling. QMS conformity is assessed as part of the authorization framework, with scope and inspection needs depending on the product and sites.

PMDA consultation can reduce uncertainty for novel technology, software, clinical evidence, and nonstandard routes. After authorization, the MAH must maintain quality and post-marketing safety systems, evaluate complaints and adverse events, manage recalls and field actions, and assess changes before implementation. Approved scope, sites, labels, and certificates must remain aligned throughout the product lifecycle.