Medical Device Regulation in Japan
Japan regulates medical devices under the PMD Act (Pharmaceuticals and Medical Devices Act). PMDA and MHLW share responsibilities. A local Marketing Authorisation Holder (MAH) is mandatory. Japan has two premarket pathways โ Shonin (approval) and Ninsho (certification) โ and often requires Japan-specific clinical data for novel devices.
Device Classification
Class I (General Medical Devices): low risk, self-certification notification. Class II (Controlled): moderate risk, certification by Registered Certification Bodies (RCBs). Class III (Specially Controlled โ lower tier): high risk, MHLW/PMDA approval. Class IV (Specially Controlled โ higher tier): highest risk (e.g., cardiac pacemakers), strictest approval with extensive clinical data required.
Official classification guidance โStandards & Key Principles
Applicable Standards
Key Principles
- Marketing Authorisation Holder (MAH) must be established in Japan
- Shonin (ๆฟ่ช) approval for Class III and IV via PMDA/MHLW
- Ninsho (่ช่จผ) certification by Registered Certification Bodies for Class II and some III
- Notification (ๅฑๅบ) self-certification for Class I
- QMS Ordinance inspection by PMDA prior to approval
- Re-examination period post-approval (typically 3 years)
Pre-Market Requirements
Full review by PMDA/MHLW: technical documentation, clinical data, QMS inspection. Target: 12 months (standard), 9 months (priority).
Certification by Registered Certification Bodies (RCBs) against MHLW certification standards. Faster than Shonin; no PMDA review for certified product standards.
Self-certification notification to local prefectural government. No pre-market technical review.
PMDA conducts on-site QMS inspection of manufacturing sites prior to Shonin approval. Foreign sites via MDSAP or PMDA inspection.
Post-Market Requirements
Post-approval monitoring period (3โ5 years). MAH collects safety/effectiveness data and submits Re-examination application to PMDA.
Deaths/serious injuries reported to PMDA within 15 days; other adverse events within 30 days.
Ongoing PMS required; Good Vigilance Practice (GVP) Ordinance governs the vigilance system.
International Recognition & Reliance
PMDA participates in MDSAP; audit reports shared with FDA, Health Canada, TGA, ANVISA.
FDA/CE clinical data accepted as supporting evidence, but PMDA often requires Japan-specific bridging data for novel devices.