Foreign Manufacturer Accreditation (FMA) — 5-Year Renewal Cycle
Key Date
2026-12-31 — Foreign Manufacturer Accreditation (FMA) — 5-Year Renewal Cycle
Foreign manufacturers must hold a valid Foreign Manufacturer Accreditation (FMA) issued by PMDA to export medical devices to Japan. FMA certificates are valid for 5 years from the date of issue, and renewal must be completed before expiry — there is no grace period, and an expired FMA invalidates the ability to export to Japan.
Key actions for FMA renewal:
- Identify your FMA expiry date from your current certificate.
- Initiate the renewal application with PMDA (via your Japan-based MAH) at least 6 months before expiry to allow for review time.
- Ensure your quality management system documentation (ISO 13485 or QMS Ordinance equivalent) is current and available for PMDA review.
- Confirm that your Japan MAH (Marketing Authorisation Holder) is prepared to submit the renewal on your behalf.
FMA renewal timelines can vary — do not rely on PMDA reminders. Set an internal alert based on your certificate expiry date.
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