Question 1

What is PMDA and what is its role in medical device regulation?

Accepted Answer

The Pharmaceuticals and Medical Devices Agency (PMDA) is Japan's independent administrative institution responsible for the technical review and safety evaluation of medical devices under the oversight of the Ministry of Health, Labour and Welfare (MHLW). PMDA conducts pre-market reviews (Shonin approval process), QMS compliance audits, post-market surveillance, and safety assessments. All medical devices marketed in Japan require PMDA/MHLW approval (Shonin), and foreign manufacturers must designate a Marketing Authorization Holder (MAH) with a qualified designated manager in Japan. Japan has a highly sophisticated regulatory system with rigorous technical review standards.

Question 2

What is the Shonin approval process and what are the different pathways?

Accepted Answer

Shonin (承認, approval) is the marketing authorization required from MHLW based on PMDA's technical review. Pathways by Device Class: Class I: Notification only (届出, todoke-de) - no pre-market approval, Class II: Certification (認証, ninsho) - third-party certification bodies (generally 3-6 months), Class III/IV: Approval (承認, shonin) - full PMDA review and MHLW approval (12-24+ months). Special Pathways: Sakigake (先駆け審査): Expedited review for innovative devices, Conditional Approval: For devices addressing urgent medical needs with limited data, Foreign Clinical Data Acceptance: International clinical studies increasingly accepted with bridge studies. Requirements: MAH designation in Japan, QMS certification (ISO 13485 + Japan-specific requirements or MDSAP), comprehensive technical documentation (CTD format for Class III/IV), clinical data (Japanese data often preferred, foreign data with ethnic factors consideration).

Question 3

What is the MAH system and what are the requirements?

Accepted Answer

The Marketing Authorization Holder (MAH) system in Japan requires that a legal entity domiciled in Japan hold the Shonin approval and take responsibility for device quality, safety, and regulatory compliance. MAH Options for Foreign Manufacturers: Japanese subsidiary of the foreign manufacturer, Japanese partner/distributor serving as MAH, regulatory consulting firm acting as MAH. Key Requirements: Legal entity registered in Japan, designated manager (管理者, kanri-sha) with required qualifications (medical device regulatory knowledge, often pharmacist license), appropriate facilities and systems for regulatory affairs and quality management, post-market surveillance and vigilance capabilities. Designated Manager Requirements: Must be qualified under Pharmaceutical Affairs Law (often pharmacist or engineer with training), physically present in Japan, responsible for device safety, quality, and compliance oversight. The MAH system ensures local accountability and expertise for Japanese market.

Question 4

What is Japan's QMS certification requirement?

Accepted Answer

Japan requires manufacturers to obtain QMS (Quality Management System) certification as part of the Shonin approval process. QMS Options: MDSAP (Medical Device Single Audit Program) including Japan component - most efficient for global manufacturers, ISO 13485 + Japan-specific requirements (PAL QMS), direct PMDA QMS audit. MDSAP Benefits: Single audit satisfies Japan (PMDA), USA (FDA), Canada, Australia, Brazil, internationally recognized and cost-effective, growing preference among global manufacturers. Timing: QMS certification must be obtained BEFORE Shonin approval, QMS audit includes document review and on-site inspection at manufacturing facility, approval process cannot complete without valid QMS certificate. Recommendations: Foreign manufacturers targeting Japan should pursue MDSAP to maximize efficiency, engage MDSAP auditing body with Japan experience, allocate 6-12 months for MDSAP process before Shonin application.

Question 5

How does Japan classify medical devices?

Accepted Answer

Japan uses a risk-based classification system: General Medical Devices (Class I): Low risk (e.g., surgical scissors, stethoscopes), notification only, no pre-market approval, Controlled Medical Devices (Class II): Medium risk (e.g., MRI, ultrasound, X-ray), certification by third-party bodies (faster than PMDA approval), Specially Controlled Medical Devices (Classes III and IV): High risk (e.g., pacemakers, stents, artificial hearts), full PMDA review and MHLW approval, most stringent clinical and technical requirements, Class IV: Highest risk, life-sustaining/implantable. Classification is based on: risk to patient, invasiveness, therapeutic nature, duration of use. Japan's classification has unique categories (e.g., 'controlled' vs. 'specially controlled') that don't directly map to EU/US systems - proper classification critical for determining regulatory pathway.

Question 6

What clinical data does PMDA require for device approval?

Accepted Answer

PMDA's clinical data requirements vary by device class and innovation level: Class I/II Devices: Generally no clinical data required, equivalence to existing approved devices, performance testing and literature may suffice. Class III/IV Devices: Clinical data often required, Japanese clinical data historically preferred (ethnic factors consideration), foreign clinical data increasingly accepted with appropriate justification. Foreign Data Acceptance: PMDA has been enhancing acceptance of international clinical studies, bridge studies may be required to demonstrate applicability to Japanese population, proper study design and GCP compliance essential. Sakigake Pathway: For innovative devices, expedited consultation with PMDA, can discuss clinical data requirements early. Trend: Japan moving toward greater acceptance of global clinical data, but culturally-sensitive approach and early PMDA consultation recommended, especially for novel high-risk devices.

Question 7

How often is Japan PMDA regulatory news updated and how can I stay informed?

Accepted Answer

PMDA and MHLW regularly publish notifications, guidance documents, and policy updates related to medical device approval, QMS requirements, and post-market obligations. Recent focus includes enhancing international harmonization (MDSAP, foreign clinical data acceptance), digital health and AI/ML device frameworks, and Sakigake expedited pathways. Our platform aggregates daily updates from 7 premium commercial sources including RAPS, Emergo by UL, Pacific Bridge Medical, and Citeline. We recommend checking this page regularly and consulting with experienced Japan regulatory advisors or MAH partners to navigate PMDA's complex requirements.

Question 8

What commercial sources does this platform use for Japan news?

Accepted Answer

We aggregate Japanese regulatory intelligence from 7 premium sources: RAPS (Regulatory Affairs Professionals Society), Emergo by UL, Citeline MedTech Insight, Pacific Bridge Medical, Asia Actual, Pure Global's proprietary research, and Qualtechs. These sources provide expert analysis, real-time updates, and strategic insights beyond basic PMDA announcements, helping you navigate Shonin approval pathways, MAH designation, QMS certification (MDSAP), clinical data requirements, and Japanese market entry strategies.

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