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 5, 2026
Approximately 5 minutes
Handling of Application for Marketing Certification of Medical Device Software in Japan
Handling of Application for Marketing Certification of Medical Device Software in Japan
1. Overview
The Handling of Application for Marketing Certification of Medical Device Software (PFSB/MDRMPE Notification No. 1125-6, November 25, 2014) provides specific guidance for applicants seeking marketing certification for to-be-certified medical device software or storage media containing such software under the Pharmaceuticals and Medical Devices Act (PMD Act). It clarifies requirements related to application content, accessory functions, essential standards, and transitional provisions. (pmda.go.jp)
2. Application Requirements
For marketing certification of medical device software or storage media containing it (hereinafter “to-be-certified medical device software”):
- Submissions should follow the general Medical Device Marketing Certification Application procedures and the Points to Consider for Application documents referenced in the notification. (pmda.go.jp)
- Applicants must explain substantial equivalency with existing approved or certified products that include equivalent medical device software (“Existing Products”). (pmda.go.jp)
- Conformity to Japanese Industrial Standards (JIS) or International Electrotechnical Commission (IEC) standards included in the certification standards may not need to be presented if they are not applicable to the software concerned. (pmda.go.jp)
3. Accessory Functions
Accessory functions of the software are acceptable only if they are accessory features of the to-be-certified medical device software, similar to Existing Products. In the application form, accessory functions must fall within the descriptions of the relevant product functions in the existing product’s certification form. The intended use must be appropriately described based on generic name definitions, and functions not yet subject to certification should not be described. (pmda.go.jp)
4. Conformity with Standards for Essential Requirements
The conformity status of the to-be-certified medical device software with the Standards for Essential Requirements is assessed using a conformity checklist derived from medical device software checklists and the relevant Ministerial Notification concerning Standards for Essential Requirements. The checklist ensures that the software meets essential safety and performance requirements for medical devices. (pmda.go.jp)
5. Scope of Certified Certification Body Activities
Activities related to conformity certification reviews of to-be-certified medical device software are categorized in relevant notifications covering third-party certification bodies. The categories of activities should be those of medical devices whose software functions are comparable to those in question. (pmda.go.jp)
6. Transitional Measures
Parties marketing to-be-certified medical device software at the time of enforcement of the Amending Act are required to submit marketing certification applications within three (3) months of the effective date. They may continue to market/distribute the products until certification status is determined. This transitional treatment ensures continuity of distribution while applications are under review. (pmda.go.jp)
7. Conclusion
This notification details regulatory expectations for marketing certification applications specific to medical device software. It clarifies how to demonstrate equivalency with existing products, handle accessory functions, conform to essential safety standards, and apply transitional measures to products already on the market. (pmda.go.jp)
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