The "Act on Securing Quality, Efficacy and Safety of Products Including Pharmaceuticals and Medical Devices" (PMD Act) enforced on 25 November 2014, regulated medical device software intended to diagnose and treat diseases as medical devices in line with global harmonization efforts. Since then, many SaMD products have been developed and have obtained marketing approval.
To promote early practical use of innovative SaMD products, PMDA provides a consolidated set of information related to the approval review of SaMD products in this website. This website is planned to be updated as latest information is announced. For information on medical device certification, please see the website for third-party certified medical devices (in Japanese).
Determination Whether Software Qualifies as a Medical Device
Under the PMD Act, software subject to medical device regulation is software (software function) that has an intended use as a medical device and has significant potential risk to the patient's (or user's) life and health when not functioning as intended. (Excluding those with little potential risk to human life and health (corresponding to a general medical device).)
For specific principles, please see the following notification.
Consultation on Qualification of Software as a Medical Device is integrated at Compliance and Narcotics Division, Pharmaceutical Safety Bureau, Ministry of Health, Labour and Welfare (MHLW). If you would like to confirm whether your software scheduled for or under development qualifies as a medical device, please follow the instruction in the below website and apply for the Consultation on Qualification of Software as a Medical Device in Comprehensive Consultation for SaMD.
Please also refer to the SaMD Case Study Database provided in the MHLW website.
- Software as a Medical Device (MHLW)(in Japanese)
In addition, "Essentials of Medical Software Development - Understanding the basics of the Guideline on Qualification of Software as a Medical Device (医療のプログラム開発のきほんープログラムの医療機器該当性に関するガイドラインの基本がよくわかるサイト; Provisional translation by PMDA)" is available as part of Health and Labour Sciences Research Grants FY2021 "Research to Identify Issues to Determine Whether Software Qualifies as a Medical Device Based on Global Harmonization Efforts (21CA2022) (国際整合性を踏まえたプログラムの医療機器該当性に係る論点抽出のための研究（21CA2022）; Provisional translation by PMDA) and FY2022-2023 "Research to Revise the Guideline on Qualification of Software as a Medical Device (プログラムの医療機器該当性に関するガイドライン改定に向けた研究（22KC1006）: Provisional translation by PMDA)" (Chief Researcher: Takashi Suzuki, Japan Association for the Advancement of Medical Equipment). The website provides clear explanations about applicability of software as a medical device, as well as quizzes to practice the decision-making process on sample cases.
PMDA Consultation on SaMD
Upon application from marketing authorization holders (MAH), PMDA provides guidance and advice on clinical trials for SaMD as well as clinical studies for their re-evaluation and re-examination. In clinical trial consultations, guidance and advice is provided to improve the quality of the clinical trial. PMDA checks whether the proposed clinical trial complies with the requirements for approval submission, considering the ethics, scientific validity and reliability of the clinical trial, as well as safety of trial subjects. Guidance and advice can also be provided for quality and non-clinical studies.
Since clinical trial consultations are provided for a fee, please first consider applying for a General Consultation, Pre-Consultation Meeting, or Regulatory Development Consultation in Comprehensive Consultation for SaMD (hereinafter referred to as "Regulatory Development Consultation"). These consultations aim to facilitate the clinical trial consultation process by structuring the agenda in advance, as well as specifying and clarifying the points of discussion. Pre-Consultation Meetings are charged, while General Consultation and Comprehensive Consultation for SaMD are without charge. There is no limit to the number of consultations, and there is no significant difference in the content of the consultations. The applicant may select their convenient consultation category from General Consultation, Pre-Consultation Meeting or Regulatory Development Consultation.
- General Consultation, Simultaneous Application Consultation, Follow-up Meetings for Medical Devices (in Japanese)
- Centralized Consultation Desk for SaMD (Comprehensive Consultation for SaMD) (in Japanese)
- Pre-Consultation Meeting (in Japanese)
Clinical trial consultations are required to seek advice from the PMDA on the necessity of clinical studies or the sufficiency of evaluations required for approval application. Since the clinical trial consultation fee differ by the consultation category, please confirm the consultation category at the General Consultation. Also, please see the PMDA website for the application procedure of clinical trial consultations.
- List of Consultation Categories (in Japanese)
- Clinical Trial Consultation (in Japanese)
Regulatory Science (RS) Strategy Consultation is a consultation system to provide guidance and advice for universities, research institutes, and venture companies, covering the formulation of necessary studies and clinical trial protocols in the final stage of selecting product development candidates to the initial stage of clinical development (Proof of Concept (POC) studies (corresponding to early phase II studies)). To promote practical use of innovative medical devices originating in Japan, universities, research institutes, and venture companies meeting certain requirements can apply for the RS Strategy Consultation at a low fee.
If you meet the requirements for a low fee etc. and you are considering applying for a RS Strategy Consultation, please apply for a Pre-Consultation Meeting (RS Strategy Consultation) to facilitate the process by structuring the agenda in advance, as well as specifying and clarifying the points of discussion.
The earliest available schedule for fee-based consultation (except for Simple Consultation) by the Office of Software as a Medical Device is as below (updated on 13 January). If you request for a preliminary advice, it will be issued at the schedule below, and the consultation meeting will take place 2 weeks after its issue. Please be aware of this schedule if you are considering applying for a consultation in the future. The earliest available schedule for consultation is updated approximately every two weeks.
- Arrangeable schedule for consultation: After April 2026
If you have already conducted a General Consultation etc. in preparation for a consultation and have any questions on the schedule arrangement, please contact the lead consultant from the completed consultation. Also, if you are planning to apply for a consultation but have not yet conducted a General Consultation etc., please apply for a General Consultation etc. before submitting a Schedule Arrangement Request Form for the consultation.
Frequently asked questions from previous General Consultations, etc., are compiled in "Guide to Regulatory Development and Approval Application of SaMD". Please refer to this guide for future product development. Please be sure to check the most recent version of this guide, since the guide will be updated as new notifications are issued.
(Attachment 1) Template to Organize Pre-Development Consultation [20.6KB] (in Japanese)Approval review
Marketing Approval Review
Please see here for information on the definition of a medical device, medical device classification, marketing procedure, approval application category and investigation related to approval review (in Japanese). Please also see here for information on the approval application procedure and points to consider when using online submissions (in Japanese), and here for information on topics related to PMDA approval review (in Japanese).
GLP / GCP / GPSP Compliance Assessment
Please see here for information on document-based compliance assessments for nonclinical and clinical studies, as well as compliance assessment procedures and points to consider for on-site GCP compliance assessment for clinical studies (See here for Japanese Page)
QMS Inspection
Please see here for information on procedures and points to consider for Quality Management System (QMS) inspections for medical device MAH and registered manufacturers (See here for Japanese Page). Please also see here for notifications regarding QMS (in Japanese).
Notifications related to SaMD
Guidance for the Evaluation of SaMD
Guidance for the Evaluation of Emerging Technology Medical Devices
Please see the National Institute of Health Sciences website for notifications issued as the Guidance for the Evaluation of Emerging Technology Medical Devices/ Cellular and Tissue-based Products. (Note: English version of the guidance is partly available in the website.)
Science Board
PMDA established the Science Board on 14 May 2012, as a high-level consultative body which discusses scientific aspects of pharmaceuticals, medical devices and regenerative medical products review. The Science Board have discussed matters related to SaMD and provided summary reports of the discussion.
Please see the Science Board website for materials submitted to the Science Board and summary reports of the discussion.
| No. | Available Summary Report of the Discussion |
|---|---|
| 1 | Regulatory Science on AI-based Medical Devices and Systems ／ Japanese Version [1.27MB] |
| 2 | Report of the Subcommittee on Computer Simulation [1.64MB] (in Japanese) |
| 3 | Report on AI-based Software as a Medical Device (SaMD) [1.29MB] ／ Japanese Version [1.61MB] |
Review Points for SaMD
On 7 June 2022, the Cabinet adopted the "Regulatory Reform Implementation Plan", including <Medical Care/ Nursing Care / Infection Measures>
Information on review points for SaMD products approved after 2014 will be compiled and provided accordingly.
When compiling review points for a product group with a small number of marketing approved products or MAH, draft of the review points will be publicly available for a certain period to solicit feedback. For details, please see the link "Under Consultation" in the below table.
- Review Point for Medical Devices (in Japanese)
Information on Approved SaMD Products
- List of Marketing Approved SaMD Products and Related Information(in Japanese)
- List of Approved Medical Devices
- Review Reports of New Medical Devices
Initiatives to Promote Practical Use of SaMD
DASH for SaMD
On 24 November 2020, MHLW announced the "DASH for SaMD (DX (Digital Transformation) Action Strategies in Healthcare for SaMD (Software as a Medical Device))"(in Japanese) and took actions to promote practical use of SaMD by establishing an approval review system and structure considering the characteristics of SaMD.
- DASH for SaMD[408KB](in Japanese)
In accordance with DASH for SaMD, PMDA strengthened its approval review system on 1 April 2021. PMDA will continue the discussion with stakeholders and commit to the early practical use of SaMD.
- Establishment of PMDA Office of Software as a Medical Device
The Office of Software as a Medical Device was established to specialize in reviewing categories classified as SaMD among the categories reviewed by the Office of Medical Devices I and Office of Medical Devices II.
- Establishment of Centralized Consultation Desk for SaMD
One-stop consultation desk was established integrating Consultation on Qualification of Software as a Medical Device, Regulatory Development Consultation and Medical Insurance Consultation.
DASH for SaMD 2
On 6 September 2023, MHLW and the Ministry of Economy, Trade and Industry announced the "DASH for SaMD 2 (DX (Digital Transformation) Action Strategies in Healthcare for SaMD (Software as a Medical Device) 2)" (in Japanese). Actions are taken to further promote practical use and international expansion of SaMD.
DASH for SaMD 2 included reorganization of PMDA's "Office of Software as a Medical Device" to strengthen its consultation and review system for SaMD. Taking this into account, PMDA reorganized the "Office of Software as a Medical Device" on 1 July 2024. Due to the increase in reviewers, the consultation and review system expanded from one to two teams, one for each review category.
| Team Name | Review Category |
|---|---|
| D1 | Ophthalmology and Otorhinolaryngology; Cardiopulmonary Circulation; Robotics, IoT, and other devices (not classified as other categories) (Category reviewed by the Office of Medical Devices I) |
| D2 | Brain and Circulatory Medicine, Respiratory Medicine, Neurology, and Psychiatry; Gastroenterology, Genitourinary, and Reproductive Medicine; Dentistry and Oral Medicine; Orthopedic and Plastic Surgery (Category reviewed by the Office of Medical Devices II) |
As part of the promotion of practical use of SaMD considering its characteristics, assumed case reports of two-step approved SaMD products are available in relevant industrial groups. Please see their websites below for your reference.
- Software for Diagnosis (The Japan Federation of Medical Devices Associations website) (in Japanese)
- Software for Treatment of Diseases (The Japan Digital Health Alliance website) (in Japanese)
Priority Review of SaMD
On 7 June 2022, the Cabinet adopted the "Grand Design and Action Plan for a New Form of Capitalism Follow-up", which states that "a system for designating and conducting approval reviews for the revolutionary Software as a Medical Device (SaMD) on a priority basis will be introduced on as a trial scheme during FY2022, in order to promote the practical utilization of SaMD." Taking this into account, products subject to Priority Review of SaMD were designated, and on a trial basis, prioritized in consultation and review and provided concierge services.
- "Trial Implementation of Priority Review of SaMD (No. 4)" (PSB/MDED Notification No. 0804-1, dated 4 August 2025)[194KB] (in Japanese)
List of products designated for Priority Review of SaMD is as follows.
Notifications on previous trial implementation of Priority Review of SaMD are as follows.
- "Trial Implementation of Priority Review of SaMD" (PSEHB/MDED Notification No. 0902-2, dated 2 September 2022) [170KB](in Japanese)
- "Trial Implementation of Priority Review of SaMD (No. 2)" (PSEHB/MDED Notification No. 0630-2, dated 30 June 2023) [168KB](in Japanese)
- "Trial Implementation of Priority Review of SaMD (No. 3)" (PSB/MDED Notification No. 0821-1, dated 23 August 2024) [488KB](in Japanese)
SAKIGAKE Designation System
On 17 June 2014, MHLW announced the "Strategy of SAKIGAKE" to promote practical use of innovative medical products. "Strategy of SAKIGAKE" aims to lead the world in practical use of the innovative medical products by promoting a package covering from basic research to clinical study/trials, approval review, insurance coverage and international expansion.
In response to the above strategy, PMDA collaborated with MHLW on "SAKIGAKE Designation System" on a trial basis since FY2015. In the revision of the PMD Act in 2019, "SAKIGAKE Designation System" was codified.
SAKIGAKE medical devices are designated by the Minister of MHLW, while seeking opinions from Pharmaceutical Affairs Council. According to the PMD Act, SAKIGAKE medical devices must meet the criteria such as innovativeness, severity of target disease, and extremely high efficacy on the target disease. This system aims to expedite the practical use of products designated as SAKIGAKE medical devices by prioritizing their consultation and review. In addition, sufficient measures will be taken according to the approval review schedule to ensure that the applicant can develop their manufacturing system and facilitate delivery of the product to the clinical practice upon its marketing approval. PMDA is collaborating with MHLW to implement this system.
For related notifications, please see the "SAKIGAKE Designation System" (See here for Japanese Page).
Also, please see the list of products subject to the SAKIGAKE Designation System in "List of SAKIGAKE Designated Products" (in Japanese).
Support Projects for Approval Application
PMDA implemented the national grant program "Support Project for Promoting Consultations/Applications for Innovative Medical Devices" aimed for small and medium-sized enterprises (SMEs) and venture companies that meet certain requirements. This program reimburses 50% of the consultation and approval application fee for the medical device, regenerative medical product or in vitro diagnostics (IVD) meeting the requirements after its full payment by the relevant company.
In addition, "Support Project for Promoting Applications for Pediatric Medical Devices” reimburses 90% of the approval application fee for the pediatric medical device after its full payment by the relevant company (however, certain conditions apply, and there is a cap on the reimbursement amount).
For details, please see "Support Project for Promoting Consultations/Applications for Innovative Medical Devices"(in Japanese) or"Support Project for Promoting Applications for Pediatric Medical Devices” (in Japanese).
Information on SaMD Seminars
Training materials on SaMD Seminars
Training materials on SaMD Seminars are publicly available.
Note: These materials were used at the SaMD Seminar held in FY2023 and are based on the information available at that time.
Video and Materials for SaMD Seminars
Video and materials used in the SaMD Seminars are publicly available. Agreement to the terms of use [227KB] (in Japanese) is required to view the seminar video.
- Video of SaMD Seminars
- Materials used in the SaMD Seminar
| No. | Theme | Released/ Updated |
|---|---|---|
| 1 | Regulation of SaMD under the PMD Act [1.58MB] (in Japanese) | 17 March 2025 |
| 2 | Process from Development to Approval Application for SaMD and PMDA Consultation [441KB] (in Japanese) | 17 March 2025 |
| 3 | Principles on Approval Review of SaMD [2.10MB] (in Japanese) | 17 March 2025 |
| 4 | Request to Applicants from the Office of Software as a Medical Device - Based on Actual Cases [1.32MB] (in Japanese) | 17 March 2025 |
| 5 | Preparation and Documents for GLP / GCP / GPSP Compliance Assessments and Issues Found in Past Assessments [1.01MB] (in Japanese) | 17 March 2025 |
| 6 | Documents for QMS Inspection Application and Issues Found in Past On-site Inspections [3.60MB] (in Japanese) | 17 March 2025 |
| 7 | Points to Consider in Preparation of Package Inserts [1.16MB] (in Japanese) | 17 March 2025 |
| 8 | Certification Standards of SaMD [1.05MB] (in Japanese) | 17 March 2025 |
For any questions on the video or slides, please email us at the following address.
(Inquiries)
Pharmaceuticals and Medical Devices Agency
Office of Software as a Medical Device
SaMD Seminar Office
Email: samd-koushuukai[at]pmda.go.jp
Note: For security purposes, @ in the email address is replaced with [at]. Please replace [at] with @ when you send an email.