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.
January 4, 2026
Approximately 5 minutes
Handling of the Data of Clinical Studies for Medical Devices Conducted in Foreign Countries in Japan
Handling of the Data of Clinical Studies for Medical Devices Conducted in Foreign Countries in Japan
1) What the notification covers
Japan’s Ministry of Health and Welfare (now MHLW) issued YAKUHATSU No. 479 (March 31, 1997) on the Handling of the data of clinical studies for medical devices conducted in foreign countries. It explains when foreign clinical study data can be accepted as application materials for review of approval of manufacture (or import) of medical devices.
Reference: YAKUHATSU No. 479 (PMDA-hosted PDF).
PMDA also lists this notification under its English Regulatory Information (Medical Devices) page in the “Clinical Trials in Foreign Countries” section, alongside later related notices (e.g., a 2006 notification and Q&A).
Reference: PMDA Regulatory Information (Medical Devices) – Clinical Trials in Foreign Countries.
2) Core rule: foreign clinical study data may be accepted if all requirements are met
The notification states that foreign clinical study data shall be accepted as application materials if they meet all requirements in the attached table.
Reference: YAKUHATSU No. 479.
It also notes that domestic clinical study data previously required as supplemental data for certain implantable devices affecting biocompatibility are, in principle, not required, except where the device has a new structure and is used for a new treatment not yet established in Japan.
Reference: YAKUHATSU No. 479.
3) The four acceptance requirements (with practical submission expectations)
Requirement 1 — Applicability to Japanese standards and medical practice
Requirement: The clinical study methods and clinical evaluation meet Japanese standards/guidelines, or are applicable to Japanese medical practices.
If not: Applicants should clarify characteristics of medical practices in the country where the study was conducted so that applicability to Japan can be evaluated.
Reference: YAKUHATSU No. 479 – Attached table.
Requirement 2 — Reliable institutions and qualified researchers
Requirement: Studies were conducted at reliable medical institutions (e.g., public institutions or university hospitals) by researchers with appropriate experience and ability.
Submission expectations: Attach materials showing (a) researcher capability (academic background, qualifications, presentations, society memberships, etc.) and (b) institution reliability.
Reference: YAKUHATSU No. 479 – Attached table.
Requirement 3 — Proper procedures and methods (ethics + GCP-equivalent)
Requirement: Studies were conducted with proper procedures/methods, including adherence to the World Medical Association Declaration of Helsinki and compliance with Japanese GCP principles for medical devices or foreign standards equivalent to or better than them.
Submission expectations: Provide materials demonstrating proper conduct (including the clinical trial protocol).
Reference: YAKUHATSU No. 479 – Attached table.
Requirement 4 — Raw data available for inspection (data integrity)
Requirement: Raw data (individual case records and statistical analysis records) that underpin the clinical study data should be available for inspection as needed.
Regulatory implication: Reliability may be examined via on-site inspection and/or submission of raw data; therefore, data needed for examination should be properly organized and managed. The clinical study data should include a signature by the person(s) who conducted the study; if signature is impossible for unavoidable reasons (e.g., death), attach a document explaining the reason.
Reference: YAKUHATSU No. 479 – Attached table.
4) Japanese translation requirement (often overlooked in planning)
Materials regarding foreign clinical study data should be accompanied by complete and accurate Japanese translation, and the qualifications/professional career of the translator(s) should be provided.
Reference: YAKUHATSU No. 479 – “Others” in attached table.
5) Effective date and related revisions
The notification applies to applications made on or after March 31, 1997.
Reference: YAKUHATSU No. 479.
It also revises the earlier 1985 notification framework by deleting the section “Regarding medical devices” from the 1985 notice and adjusting wording in the acceptance requirements table referenced there.
Reference: YAKUHATSU No. 479.
6) Practical checklist for applicants using foreign clinical data
- Japan-applicability rationale: Map study endpoints, clinical pathways, operator skills/training, and standard-of-care differences to Japanese practice; document why results translate (or what controls are needed).
- Institution/researcher credibility pack: Prepare investigator CV evidence and institutional reliability evidence as explicit attachments.
- Ethics/GCP evidence bundle: Keep protocol(s), ethics documentation, and proof of GCP-equivalent conduct ready for review.
- Audit readiness: Ensure raw data, case records, and analysis traceability are inspection-ready; plan for potential on-site inspection.
- Translation governance: Use qualified translators, preserve consistency across documents, and disclose translator credentials.
7) How PMDA frames this today (context)
PMDA’s English FAQ confirms that PMDA accepts foreign clinical data for medical device marketing approval in Japan and points applicants to the relevant notifications (including this 1997 notice).
Reference: PMDA FAQ – Q2-6.
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