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PMDA and Prefectural QMS Inspections

JP-unique

QMS inspections of manufacturing sites in Japan are conducted by two separate bodies — PMDA (for higher-risk devices and foreign sites) and prefectural governments (for domestic manufacturing sites). This split is unique to Japan.

PMDA inspection scope and authority​

PMDA conducts QMS inspections for:

  • Manufacturing sites involved in the production of Class III and IV devices — pre-approval inspection required as part of the Shonin process
  • Foreign manufacturing sites registered under FMR, regardless of device class (though frequency and depth vary)
  • Sites where safety concerns have been identified (for-cause inspections)

PMDA inspections assess compliance with MO 169. Inspectors are PMDA staff with expertise in the relevant device categories and QMS standards.

Prefectural government inspection scope​

Prefectural governments inspect:

  • Domestic manufacturing sites for Class I and Class II devices
  • Domestic MAH offices — the prefectural government that issued the MAH licence can inspect the MAH's quality oversight activities

Prefectural inspection depth is typically less intensive than PMDA inspections, but non-compliance findings are reported to MHLW and can trigger further action.

Pre-approval inspections​

For most Shonin applications, PMDA conducts a pre-approval QMS inspection of all manufacturing sites listed in the application. The inspection:

  • Is typically scheduled by PMDA during the application review process
  • Covers the QMS as it applies to the specific device being reviewed
  • Results in an inspection report submitted to MHLW as part of the approval decision

If significant findings are identified at the pre-approval inspection, the approval will not be issued until the findings are resolved.

Routine and for-cause inspections​

After approval, manufacturing sites are subject to periodic routine inspections on a risk-based schedule. Sites with history of good compliance are inspected less frequently.

For-cause inspections are triggered by:

  • Adverse event reports suggesting a manufacturing quality problem
  • Recall or FSCA actions
  • Complaints about QMS compliance

Foreign site inspection — process for overseas manufacturers​

For a PMDA on-site inspection of a foreign manufacturing site:

  1. PMDA notifies the MAH of the inspection date (typically 2–3 months' notice for a routine inspection)
  2. The MAH coordinates with the overseas manufacturer to confirm availability and arrange logistics
  3. PMDA inspectors travel to the site (typically 2–3 inspectors for 2–3 days)
  4. An interpreter (usually arranged by the MAH) facilitates communication
  5. Inspection findings are communicated to the MAH in writing after the inspection
  6. The MAH coordinates the site's response to findings