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Foreign Manufacturer Registration (FMR)

JP-unique

Foreign Manufacturer Registration (FMR / 外国製造業者認定) is a registration system that allows overseas manufacturing sites to supply medical devices to Japan through a Japan-based MAH. FMR is mandatory for all overseas sites whose products are to be covered by a Japanese approval or certification.

What FMR covers​

FMR registration covers a specific manufacturing site at a specific address. A company with multiple manufacturing sites must register each site separately if each site manufactures products intended for the Japanese market.

The FMR registration specifies:

  • The manufacturing facility name and address
  • The types of manufacturing activities performed
  • The Japan-based MAH that applied for the FMR on behalf of the site

Application process via the MAH​

The overseas manufacturer does not apply for FMR directly. The Japan-based MAH submits the FMR application to MHLW on behalf of the overseas manufacturer.

Application steps:

  1. MAH compiles required information about the foreign manufacturing site
  2. MAH submits the FMR application to MHLW (national level, not prefectural)
  3. MHLW reviews the application — typically within 3 months
  4. MHLW issues the FMR certificate with an FMR number
  5. The FMR number is used in subsequent Shonin/Ninsho applications for products from that site

FMR and the pre-market application timeline​

FMR must be obtained before or simultaneously with the pre-market application. It is common practice to submit the FMR application together with the Shonin application, with PMDA holding the full review pending FMR issuance.

Maintaining FMR — annual confirmation and changes​

FMR registrations must be confirmed annually by the MAH. If the manufacturing activities, site address, or responsible person changes, the MAH must notify MHLW.

If the MAH changes, the FMR must be retransferred to the new MAH's name.

QMS inspections for FMR sites​

Foreign sites registered under FMR are subject to PMDA QMS inspections. These inspections assess compliance with MO 169. PMDA may inspect on-site (typically combined with a scheduled pre-approval inspection) or may conduct document-based reviews for lower-risk devices or well-established sites.