PMDA & MHLW โ Japan's Medical Device Regulatory System
Medical devices in Japan are regulated under the Act on Securing Quality, Efficacy and Safety of Products Including Pharmaceuticals and Medical Devices (PMD Act, ่ฌๆฉๆณ). The Pharmaceuticals and Medical Devices Agency (PMDA) conducts technical review, while the Ministry of Health, Labour and Welfare (MHLW) issues final marketing approvals (shonin) or certifications (ninsho).
Japan's system requires a Marketing Authorization Holder (MAH) โ a Japan-licensed entity that holds the approval and bears full regulatory responsibility. Foreign manufacturers must either establish a Japan subsidiary or appoint a Designated MAH (DMAH) โ a licensed Japanese entity authorized to hold approvals on the manufacturer's behalf. JNPMEDI APAC coordinates DMAH appointment and manages the full approval lifecycle.
Class III and IV devices require shonin (MHLW approval) with full PMDA review. Class II devices undergo ninsho (third-party certification) through a Registered Certification Body (RCB). Class I devices require only notification (todokede). Japan also offers SAKIGAKE designation โ a fast-track pathway for innovative devices addressing unmet medical needs with priority review.
- Japan-licensed MAH or DMAH required โ foreign manufacturers cannot hold approvals directly
- GQP (quality agreement) and GVP (vigilance system) compliance mandatory for all MAH/DMAH holders
- PMDA review for Class IIIโIV; RCB certification for Class II; todokede notification for Class I
- NHI (National Health Insurance) drug/device pricing approval required for reimbursement
- SAKIGAKE fast-track available for innovative devices โ priority review in 6โ9 months
PMDA Review Timelines by Device Class
Target review times from submission โ GQP/GVP setup and NHI pricing listed separately.
Integrated Services for Japan PMDA Registration
PMDA Device Registration
Shonin and ninsho application management for Class IIโIV devices โ technical dossier preparation (eCTD format), PMDA consultation coordination, deficiency response, and approval tracking. SAKIGAKE designation assessment included.
DMAH Coordination & MAH
JNPMEDI APAC coordinates appointment of a Japan-licensed DMAH and manages the full GQP/GVP compliance infrastructure โ quality agreements, vigilance systems, and deviation management โ required for all Japan MAH/DMAH holders.
NHI Listing & Reimbursement
Post-approval NHI pricing application and reimbursement strategy โ the essential step for commercial access in Japan's universal health insurance system. Covers NHI code application, pricing negotiation support, and annual repricing management.
Why JNPMEDI APAC for Japan PMDA Registration
JNPMEDI APAC's parent organization (JNPMEDI, Korea) has deep MFDS expertise. Japan's PMDA and Korea's MFDS share significant alignment in dossier structure and clinical evidence requirements. Our team leverages MFDS-approved technical files to reduce Japan dossier preparation cost and time โ a unique advantage for Korean device manufacturers entering Japan.
Japan's GQP (quality) and GVP (vigilance) obligations are ongoing, not just approval requirements. JNPMEDI APAC coordinates the full GQP/GVP compliance infrastructure via our DMAH network โ including quality agreements, change control, periodic safety reporting, and MHLW incident reporting.
Japan is the world's third-largest medical device market at $4.21T GDP and ~10.7% healthcare spend. Despite high regulatory complexity, approval here commands premium NHI pricing and signals global product quality. JNPMEDI APAC builds Japan registration programs designed for long-term market presence, not just initial approval.
Japan PMDA Registration โ FAQ
A Designated Marketing Authorization Holder (DMAH) is a Japan-licensed entity authorized to hold PMDA/MHLW approvals on behalf of a foreign manufacturer. Foreign companies cannot hold Japan medical device approvals directly โ they must either establish a Japan subsidiary or appoint a licensed DMAH. JNPMEDI APAC coordinates DMAH appointment through our Japan partner network and manages all GQP/GVP obligations on your behalf.
Shonin (ๆฟ่ช) is a full PMDA technical review leading to MHLW marketing approval โ required for Class III and IV (higher-risk) medical devices. Ninsho (่ช่จผ) is certification through a Registered Certification Body (RCB) โ applicable to Class II devices that conform to standards. Ninsho is generally faster (6โ9 months) versus shonin (12โ24+ months). Class I devices require only todokede (ๅฑๅบ) notification.
SAKIGAKE (ๅ ้ง็ๅป่ฌๅ็ญๆๅฎๅถๅบฆ) is Japan's priority review designation for innovative medical devices, drugs, and diagnostics that address unmet medical needs and are likely to be developed primarily in Japan. Designated devices receive priority consultation, accelerated PMDA review (targeting 6-month total review from application), and rolling submission. Eligibility requires demonstrated innovation, serious disease indication, and development commitment in Japan.
Yes, for reimbursed commercial access. PMDA/MHLW approval allows legal market placement, but actual hospital adoption in Japan requires NHI (National Health Insurance) listing and pricing approval โ a separate process handled by the Central Social Insurance Medical Council (Chuikyo). NHI listing typically adds 3โ6 months post-approval and determines the reimbursement price that drives commercial viability in Japan's hospital procurement system.