Foreign Manufacturers
Foreign manufacturers supplying medical devices to Japan cannot hold a Japanese manufacturing licence, but they must complete Foreign Manufacturer Registration (FMR) with MHLW.
What FMR is
Foreign Manufacturer Registration (外国製造業者認定 — gaikoku seizō gyōsha ninte) is a registration (not a licence) that allows an overseas manufacturing facility to supply finished devices to Japan via a Japan-based MAH. Without FMR, the manufacturing site cannot be named in a Japanese approval or certification.
FMR is applied for by the Japan-based MAH on behalf of the overseas manufacturer. The overseas manufacturer does not apply directly.
What FMR does not authorise
FMR does not allow the foreign manufacturer to:
- Hold a Shonin or Ninsho in their own name
- Deal directly with MHLW on approval matters
- Bypass the MAH requirement
All regulatory communications with MHLW remain the responsibility of the MAH.
QMS inspection obligations
Foreign manufacturing sites registered under FMR are subject to QMS inspections conducted by PMDA. These inspections assess compliance with MO 169. PMDA may inspect overseas sites either on-site or, in some circumstances, through document review. The frequency of inspection depends on the device class and the outcome of previous inspections.
See PMDA and Prefectural QMS Inspections for more detail.
Practical approach
Most overseas manufacturers entering Japan:
- Appoint a Japan-based MAH (subsidiary or third-party service company)
- Apply for FMR through the MAH as part of the Shonin/Ninsho application process
- Prepare their QMS documentation to demonstrate MO 169 compliance, drawing on their existing ISO 13485 system
- Cooperate with PMDA inspections as directed by the MAH