Local Regulatory Experts
Connect with regulatory affairs consultancies specializing in this region.
Qualtech Consulting Corporation
Taiwan, China, Japan, Singapore, Hong Kong, Malaysia, Philippines, Vietnam, Australia, Germany, Korea, Thailand, USA
A specialized medical device consulting firm offering a one-stop solution for complex global regulatory challenges. We offer real-time regulatory and clinical support, local representation, and QMS services across 13 markets, ensuring efficient market entry and compliance.
Cobridge Co., Ltd.
Tokyo, Japan
We assist medical device companies with the medical device registration and approval in Japan. Regulatory consulting services and DMAH services for foreign manufacturers to enter Japanese market.
MDREX, Medical Device, Digital Health Consulting Group
Seoul, Republic of Korea (HQ), Japan Office
We offer total solutions for market entry in South Korea and global expansion (e.g., Japan, USA, Europe). Key areas include product approval, reimbursement listings (HIRA), and Quality System certification (KGMP). They are particularly strong in innovative products like SaMD, medical wearables, and 3D printing for medical use, and provide in-depth expertise in cybersecurity and clinical trial planning.
CMIC Holdings Co., Ltd.
Tokyo, Japan (HQ), Osaka, Japan, Beijing, China, Seoul, South Korea, Taipei, Taiwan, Singapore, New York, USA, London, UK, Frankfurt, Germany, Sydney, Australia
We operate globally, specializing in accelerating the development, manufacturing, and commercialization of drugs and medical devices. Their expertise spans Phase I to IV clinical trials, regulatory affairs, quality assurance, and manufacturing, with a strong focus on the Japanese and Asian markets. Key services include clinical operations (CRO), manufacturing (CDMO/CMO), site management (SMO), and comprehensive health analysis and solutions.
December 21, 2025
Approximately 5 minutes
PMDA in Japan: What It Does, What It Doesn’t, and How to Work with It
PMDA in Japan: what it is and how it works (practical overview)
What is PMDA?
PMDA (the Pharmaceuticals and Medical Devices Agency) is Japan’s regulatory agency that scientifically reviews the quality, safety, and efficacy of medical products to be marketed in Japan.1 PMDA works together with Japan’s Ministry of Health, Labour and Welfare (MHLW) and describes its obligation as protecting public health by assuring the safety, efficacy, and quality of pharmaceuticals and medical devices.2
PMDA’s core responsibilities: a “safety triangle”
PMDA explains that it delivers comprehensive risk management through three major functions (often described as a “safety triangle”):2
- Reviews (pre-market)
Scientific reviews of marketing authorization applications and related services such as consultations, and inspections/assessments supporting regulatory submissions.2 - Post-marketing safety measures (post-market)
Collecting and organizing safety information, conducting scientific research/analysis, and providing safety information related to medical products.2 - Relief services for adverse health effects
Providing relief compensation for people who suffer health damage such as adverse drug reactions and infections associated with pharmaceuticals or biological products.2
What PMDA does not do (common misconceptions)
The PMDA FAQ is explicit about several boundaries that are important for international teams:1
- No business matchmaking: PMDA does not introduce or intermediate companies/organizations in Japan.1
- No disclosure of products under review: PMDA does not provide information about products already submitted for marketing approval or currently under review.1
- No list of Marketing Authorization Holders (MAHs): PMDA does not provide a list of MAHs.1
- No non-Japanese submissions: PMDA does not accept marketing applications in languages other than Japanese; forms related to the marketing application must be submitted in Japanese.1
These boundaries shape how you should plan your Japan strategy: you typically need appropriate Japan-based regulatory roles (e.g., MAH) and a plan for Japanese-language documentation and interactions.
Where PMDA directs you instead
In the same FAQ, PMDA frequently points users to the right channel depending on the question:1
- Product classification / administrative decisions: MHLW is the authority PMDA points to for classification questions under Japan’s PMD Act processes.1
- Regulatory pathways and services: PMDA points to its official pages for “Outline of Reviews and Related Services” and “Consultations” for structured guidance.1
How to engage PMDA effectively (practical tips)
- Define the question as a regulatory decision problem
Frame what you need PMDA to evaluate (quality/safety/efficacy evidence), aligned with the review purpose described by PMDA.1 - Bring a clear evidence map
Summarize what data exists, what is planned, and what the key uncertainties are. - Use PMDA consultations when you need formal input
PMDA states it provides various consultation services for R&D and regulatory submission planning.1 - Plan for Japanese-language requirements early
Because submissions must be in Japanese, you need translation strategy, document control, and Japan-ready templates from the start.1
Q&A (for global teams)
Q1: In one sentence, what does PMDA do?
PMDA scientifically reviews the quality, safety, and efficacy of medical products marketed in Japan and supports lifecycle safety and relief functions.12
Q2: Can PMDA help us find a Japanese partner, distributor, or MAH?
No. PMDA states it does not introduce/intermediate companies and it does not provide a list of MAHs.1
Q3: Can we submit our marketing application in English?
No. PMDA states it does not accept applications in other languages and requires marketing-application forms to be submitted in Japanese.1
Q4: Can PMDA tell us what products are currently under review?
No. PMDA states it does not provide information on products whose applications are already submitted or under review.1
Q5: If we need PMDA’s opinion on our development plan, what should we do?
Use PMDA’s consultation services—PMDA states various types of consultations are available for R&D and regulatory submissions.1
Q6: Who decides if our product is a “medical device” or how it’s classified?
PMDA points users to MHLW and local authorities for classification-related processes, and emphasizes that procedures depend on the specific product and Japanese regulatory framework.1
References
Footnotes
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PMDA, “Frequently Asked Questions (FAQ)” (About PMDA). https://www.pmda.go.jp/english/about-pmda/0004.html ↩ ↩2 ↩3 ↩4 ↩5 ↩6 ↩7 ↩8 ↩9 ↩10 ↩11 ↩12 ↩13 ↩14 ↩15 ↩16 ↩17 ↩18
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PMDA, “Outline of PMDA” (Who We Are; core services and responsibilities). https://www.pmda.go.jp/english/about-pmda/outline/0005.html ↩ ↩2 ↩3 ↩4 ↩5 ↩6
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Japan Medical Device Registration: Pathways and Requirements
The medical device registration process in Japan is overseen by the PMDA and varies significantly based on device classification (Class I to IV). Key pathways include Pre-Market Submission (PMS), Pre-Market Certification (PMC), and Pre-Market Approval (PMA).
Approximately 5 minutes
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Approximately 5 minutes
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Japan Specialty Fulfillment for Medical Devices: Low Volume, High Value Sales
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Regulatory Science in Japan: PMDA’s Evidence-Based Approach to Innovation and Public Health
This article explains what “regulatory science” means in Japan and how the PMDA advances it through organizational structures, expert deliberation, collaborations, and research dissemination. A practical Q&A is included for industry and academia.