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Domestic Manufacturers

Any entity that manufactures medical devices in Japan must hold a manufacturing business licence (製造業許可 — seizō gyō kyoka) issued by the prefectural government of the prefecture in which the facility is located.

Manufacturing licence types​

There are two main categories of manufacturing business licence under the PMD Act:

General manufacturing licence — required for facilities that manufacture the final finished device, perform sterilisation, or conduct final packaging/labelling. This is the most common licence type.

Manufacturing registration (製造業登録 — seizō gyō tōroku) — a lighter-touch registration (rather than full licence) introduced for certain lower-risk manufacturing activities.

The type of licence required depends on the device class and the specific manufacturing activities performed at the facility.

Relationship with the MAH​

A domestic manufacturer is distinct from the MAH unless both roles are held by the same company. The domestic manufacturer:

  • Must maintain a QMS that complies with MO 169
  • Is subject to inspection by the prefectural government and, for higher-risk devices, by PMDA
  • Must contract with the MAH to define each party's responsibilities
  • Supplies the MAH with manufacturing information and quality records needed for the approval application and re-examination

QMS obligations under MO 169​

All licensed domestic manufacturers must maintain a quality management system that complies with Ministerial Ordinance 169 (QMS Ordinance). See QMS Ordinance Overview for full requirements.

Licence renewal​

Manufacturing business licences must be renewed every 5 years. The renewal requires demonstrating continued QMS compliance and facility capability.