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PMDA vs MHLW — Who Does What?

JP-unique

Japan's split between PMDA (scientific review agency) and MHLW (regulatory authority that issues approval decisions) is unique among major medical device markets. In most other markets, a single authority conducts both the review and issues the approval decision.

Ministry of Health, Labour and Welfare (MHLW)​

MHLW (厚生労働省 — Kōsei Rōdōshō) is a cabinet-level ministry of the Japanese government. Its responsibilities relevant to medical devices include:

  • Issuing formal approvals (Shonin) — the legal approval decision is an MHLW ministerial decision, not a PMDA decision
  • Setting policy and legislation — MHLW drafts amendments to the PMD Act, issues Ministerial Ordinances, and publishes administrative notifications
  • Designating recognised standards — the list of standards eligible for use in Ninsho applications is maintained by MHLW
  • Recall authority — MHLW has legal authority to order recalls and enforcement actions
  • Licensing authority — for certain MAH and manufacturing licences, particularly for higher-risk devices, MHLW (rather than the prefectural government) is the licensing authority

MHLW does not conduct day-to-day scientific review of applications. That work is delegated to PMDA.

Pharmaceuticals and Medical Devices Agency (PMDA)​

PMDA (独立行政法人 医薬品医療機器総合機構 — Pharmaceuticals and Medical Devices Agency) is an independent administrative agency established in 2004. Its responsibilities include:

  • Scientific review of Shonin applications — PMDA's review team assesses the safety, efficacy, and quality data submitted in approval applications and produces a review report
  • Pre-submission consultations — manufacturers can meet with PMDA to discuss their development plans, data packages, and application strategy before submitting
  • QMS inspections — PMDA conducts quality management system inspections of manufacturing sites for higher-risk devices, including foreign sites
  • Post-market safety surveillance — PMDA collects and analyses adverse event reports and issues safety communications
  • Relief service — PMDA administers Japan's adverse reaction relief fund, which compensates patients harmed by approved medical products

PMDA's review report is submitted to MHLW, which then makes the final approval decision. In practice, MHLW rarely overturns a PMDA recommendation, but the formal legal decision remains with MHLW.

Prefectural governments​

Prefectural governments (都道府県 — todōfuken) play a significant role in medical device regulation that has no parallel in EU or US systems:

  • MAH licence issuance — most MAH licences are issued by the prefectural government of the prefecture where the MAH's principal office is located (Tokyo Metropolitan Government for most pharmaceutical/device companies)
  • Manufacturer licence issuance — domestic manufacturing licences are typically issued by the prefectural government of the prefecture where the facility is located
  • Class I notification filing — Todokede notifications for Class I devices are filed with the prefectural government
  • Prefectural inspection authority — prefectural governments can inspect licensed MAHs and manufacturers within their jurisdiction

How the bodies work together — Shonin workflow​

Manufacturer/MAH → Submits application dossier → PMDA
                                                      ↓
                                              PMDA scientific review
                                              (queries ↔ applicant)
                                                      ↓
                                              PMDA review report
                                                      ↓
                                         MHLW Pharmaceutical Affairs
                                         and Food Sanitation Council
                                                      ↓
                                              MHLW approval decision
                                                      ↓
                                         MAH receives Shonin number

For Ninsho (certification), PMDA is not involved — the application goes directly to the Registered Certification Body (RCB) chosen by the MAH.

For QMS inspections related to Shonin applications, PMDA directly inspects the manufacturing sites and reports findings to MHLW as part of the approval process.