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Domestic Manufacturing Licence (Seizou Gyosha)

JP-unique

Any entity manufacturing medical devices in Japan must hold a manufacturing business licence (製造業許可) or registration (製造業登録) issued by the prefectural government (or MHLW for certain higher-risk categories). This domestic licensing requirement is separate from the MAH licence.

Types of manufacturing licence​

Full manufacturing licence (製造業許可 — seizō gyō kyoka) Required for manufacturing facilities that:

  • Perform final assembly of the finished device
  • Conduct final sterilisation
  • Perform final packaging and labelling
  • Manufacture Class III or IV devices

Manufacturing registration (製造業登録 — seizō gyō tōroku) A lighter registration (rather than full licence) for facilities conducting:

  • Processing activities that are not final assembly (e.g. subcomponent manufacturing)
  • Certain lower-risk manufacturing activities for Class I and II devices

The specific requirement (licence vs registration) depends on the device class and the manufacturing activities performed.

Application requirements​

A manufacturing licence application to the prefectural government requires:

  • Application form (prescribed format)
  • Description of the manufacturing facility and equipment
  • Description of manufacturing activities to be conducted
  • Evidence that the facility is suitable (floor plans, clean room certification where applicable)
  • Identification of the responsible manufacturing manager (製造管理者 — seizō kanrisha) — a qualified individual responsible for QMS compliance at the site

Licence renewal — 5-year cycle​

Domestic manufacturing licences expire every 5 years and must be renewed. The renewal requires demonstrating continued compliance with MO 169. A PMDA or prefectural government inspection may be conducted as part of the renewal process.

Change notifications​

The following changes require notification to (or authorisation from) the licensing authority:

  • Change in the responsible manufacturing manager
  • Change in the types of manufacturing activities performed
  • Major facility changes affecting manufacturing capability
  • Change in address or facility location