🇯🇵Japan Medical Device Regulations

Latest PMD Act Amendments and Updates

Latest amendments and regulatory updates to the PMD Act. Includes revisions to approval pathways, QMS requirements, and SaMD regulations.

QMS Ministerial Ordinance (MHLW MO169)

QMS requirements for medical devices under MHLW MO169, aligned with ISO 13485:2016. PMDA conducts QMS inspections for manufacturing sites. MDSAP reports accepted.

Pharmaceutical and Medical Device Act (Act No. 145 of 1960) - English Translation

Official English translation of the PMD Act (formerly Pharmaceutical Affairs Act). Primary legislation governing medical devices, including classification, approval, and manufacturing requirements.

Medical Device Regulations and Approval/Certification

Comprehensive guide to Shonin (MHLW approval) for Class III/IV devices. Covers all approval pathways, MAH requirements, and classification-based procedures.

Third-Party Certification (Ninsho) - RCB Assessments

PMDA assessments of Registered Certification Bodies (RCBs). Ninsho certification pathway for Class II/III devices with certification standards. RCBs must comply with ISO/IEC 17065.

Medical Device Standards for Class I Notification

Medical device standards for Todokede (notification) pathway. Class I devices require pre-market notification. Standards for safety and performance requirements.

Medical Devices Regulatory Information Portal

PMDA medical devices regulatory portal. Japan uses 4-class risk-based classification: Class I (general), Class II (controlled), Class III (highly controlled), Class IV (specially controlled).

Accreditation of Foreign Manufacturers

Foreign manufacturer accreditation requirements. Foreign manufacturers must appoint a Japanese Marketing Authorization Holder (MAH) to register and market medical devices in Japan.

Pharmaceuticals and Medical Devices Agency - Official Portal

PMDA is the regulatory agency responsible for medical device approval, safety surveillance, and relief services. Operates under Ministry of Health, Labour and Welfare (MHLW).