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.
Recent Regulatory Updates
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Updated inspection procedures for pharmaceutical data.
New drug-agnostic CDx framework for EGFR testing.
New standardized AER terminology with codes.
Sources Tracked by Qalico
Qalico continuously monitors 10 references across guidelines, regulations, and standards for Japan.
Guidelines
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.