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 2, 2026
Approximately 5 minutes
PMDA’s Activities Leading to Medical Device Innovation in Japan
PMDA’s Activities Leading to Medical Device Innovation in Japan
1. Introduction
The PMDA’s Activities Leading to Medical Device Innovation brochure highlights Japan’s regulatory environment and support mechanisms aimed at promoting medical device innovation. The PMDA (Pharmaceuticals and Medical Devices Agency) helps developers navigate regulatory science, strategy planning, and international harmonization to enable timely introduction of innovative devices into clinical use. (pmda.go.jp)
2. Strategy Consultations and Regulatory Science Support
PMDA provides strategy consultations and Regulatory Science (RS) consultations on R&D strategy to support developers from early stages of product planning through clinical and regulatory pathways. These services help establish reliable roadmaps, enhance clinical study quality, and align development plans with Japanese regulatory expectations. The RS consultations may involve expert technical discussions and guidance tailored to innovative device development. (pmda.go.jp)
3. Predictability of Review Processes
PMDA aims to ensure a predictable review process for new medical devices by working toward target review times (e.g., 14 months for standard new device applications and 10 months for priority review applications). This predictability helps developers plan timelines and manage regulatory risks more effectively. Review teams engage external experts to ensure scientific and technical rigor in evaluations. (pmda.go.jp)
4. Support Programs and Innovation Bridges
To bridge promising research seeds and commercial products, PMDA supports programs that provide guidance to venture companies, academic institutions, and industry stakeholders. For example, the MEDISO (Medical Innovation Support Office) offers free consultations and connects developers with regulatory and commercialization expertise. Clinical Research Core Hospitals (CRCHs) also play a role in facilitating high-standard research and development. (pmda.go.jp)
5. International Harmonization and Outreach
PMDA participates actively in international harmonization frameworks, such as the International Medical Device Regulators Forum (IMDRF), and promotes cooperation with overseas regulatory authorities. These efforts help align Japan’s regulatory standards with global practices and facilitate cross-border development and acceptance of innovative medical devices. PMDA also disseminates information internationally through newsletters, translated review reports, and overseas offices. (pmda.go.jp)
6. Contribution to Early Patient Access
By combining consultations, predictable reviews, international cooperation, and developer support, PMDA’s activities aim to shorten development cycles and support earlier patient access to innovative medical devices. Outreach to start-ups and support for rare-disease device development are part of this broader mission. (pmda.go.jp)
References
- PMDA: PMDA’s Activities Leading to Medical Device Innovation (brochure, Dec 2025) (pmda.go.jp)
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