PMDA

The Pharmaceuticals and Medical Devices Agency (PMDA) is Japan's regulatory agency responsible for reviewing pharmaceuticals and medical devices to ensure their safety, efficacy, and quality. It operates under the Ministry of Health, Labour and Welfare (MHLW).

PMDA responsibilities:
- Review and approval of medical device applications
- Consultation services for manufacturers
- Post-market safety monitoring
- Relief services for adverse health effects
- Standards development

Medical device classification in Japan:
- Class I - General medical devices (notification)
- Class II - Controlled medical devices (third-party certification)
- Class III - Specially controlled devices (PMDA approval)
- Class IV - Highly controlled devices (PMDA approval)

Approval pathways:
1. Shonin (承認) - Full PMDA approval for Class III/IV
2. Ninsho (認証) - Certification by Registered Certification Body (Class II)
3. Todokede (届出) - Notification for Class I

Registration requirements:
- Marketing Authorization Holder (MAH) must be Japanese entity
- Japanese Product Master File (J-PMF) or technical documentation
- Clinical data often required (may accept foreign data)
- Japanese language labeling
- QMS compliance (MHLW Ordinance No. 169)

Key features:
- Pre-submission consultations available
- SAKIGAKE designation for breakthrough devices
- Fast track for devices with foreign approvals
- Mutual recognition agreements with some countries

Timeline: 10-14 months for Shonin, 3-6 months for Ninsho, depending on device class and consultation history.