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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

The responsible manufacturing manager (製造管理者 — seizō kanrisha) must meet specific qualification requirements, typically including formal education in engineering or life sciences and documented experience in medical device manufacturing or quality management. Proof of qualifications must be submitted with the licensing application.