Inspection Triggers and Timelines

Pre-approval inspections — when required

A PMDA pre-approval QMS inspection is typically required for all Shonin applications covering Class III and IV devices, and for Class II devices with novel or complex manufacturing. The inspection is coordinated with the application review timeline.

Timeline: PMDA usually schedules the pre-approval inspection approximately 6–9 months after application submission, timed to allow the review team to identify any QMS-relevant questions before the inspection.

Periodic routine inspections

After approval, manufacturing sites are periodically re-inspected. The frequency is based on:

• Device class (Class IV sites inspected more frequently)
• Inspection history (sites with past findings inspected more frequently)
• Time since last inspection

Typical routine inspection frequency:

• Class IV / high-risk Class III: every 3–4 years
• Class II / lower Class III: every 4–6 years
• Sites with outstanding findings or recent adverse events: more frequently

For-cause inspections

PMDA may initiate an unannounced or short-notice inspection at any time in response to:

• A reported serious adverse event with a potential manufacturing cause
• A recall or FSCA involving a manufacturing defect
• Information from overseas regulatory authorities about QMS failures at the site
• Intelligence from market surveillance suggesting compliance issues

What to expect — inspection duration

Inspection type	Typical duration
Pre-approval inspection (foreign site)	2–3 days on-site
Routine inspection (foreign site)	1–2 days on-site
Document-based review	2–4 weeks (PMDA reviews documentation sent remotely)
Prefectural inspection (domestic site)	0.5–1 day