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Foreign Manufacturer Registration (FMR)

note

See also Foreign Manufacturer Registration in the Quality Management section for QMS inspection obligations for registered sites.

Overview​

Foreign Manufacturer Registration (FMR) is the MHLW registration that allows a foreign manufacturing site to supply medical devices to Japan through a Japan-based MAH. Without FMR, a manufacturing site cannot be named in a Japanese approval or certification.

How FMR relates to the MAH​

The MAH applies for FMR on behalf of the overseas manufacturer. The FMR certificate names both the manufacturing site and the MAH that applied for it. If the MAH changes, the FMR must be retransferred to the new MAH.

Key steps in obtaining FMR​

  1. MAH assembles the FMR application package — site name, address, manufacturing scope
  2. MAH submits to MHLW (national level)
  3. MHLW issues FMR certificate with FMR number (typically within 3 months)
  4. FMR number is referenced in all subsequent Shonin/Ninsho applications for products from that site

Annual confirmation​

FMR registrations must be confirmed annually by the MAH. The MAH files an annual confirmation with MHLW confirming the site's continued registration. Failure to file annual confirmation risks lapsing the FMR.