PMDA Provides Guidance and Consultation Services for SaMD Approval

The "Act on Securing Quality, Efficacy and Safety of Products Including Pharmaceuticals and Medical Devices" (PMD Act) took effect on 25 November 2014, bringing software intended to diagnose or treat diseases under medical device regulation in Japan. Since then, many SaMD products have been developed and have obtained marketing approval. To promote early practical use of innovative SaMD products, PMDA offers a consolidated website with information related to SaMD approval reviews, which is updated as new information becomes available. Information on medical device certification is provided on a separate Japanese‑language site. Under the PMD Act, software is subject to medical device regulation when its intended use carries a significant potential risk to a patient’s (or user’s) life or health if it does not function as intended. Low‑risk software is excluded. Specific principles are detailed in a related notification. The Consultation on Qualification of Software as a Medical Device is managed by the Compliance and Narcotics Division, Pharmaceutical Safety Bureau, Ministry of Health, Labour and Welfare (MHLW). Developers can follow the instructions on the PMDA website to apply for this comprehensive SaMD qualification consultation and may also refer to the SaMD Case Study Database provided by MHLW. PMDA also provides the "Essentials of Medical Software Development" guide, produced under FY2021 and FY2022‑2023 research projects, which explains the applicability of software as a medical device and includes quizzes to practice decision‑making on sample cases. When marketing authorization holders apply, PMDA offers guidance and advice on SaMD clinical trials and re‑evaluation studies. The agency reviews whether proposed trials meet approval requirements, considering ethics, scientific validity, reliability, and subject safety. These clinical trial consultations are provided for a fee. Before seeking fee‑based clinical trial consultation, applicants are encouraged to consider a General Consultation, Pre‑Consultation Meeting, or Regulatory Development Consultation (the latter includes a free General Consultation and Comprehensive Consultation, while Pre‑Consultation Meetings are charged). There is no limit to the number of consultations, and applicants may choose the category that best fits their needs. In addition to Regulatory Development Consultation, the Comprehensive Consultation for SaMD includes categories such as Qualification of Software as a Medical Device and Medical Insurance Consultation. Multiple categories can be applied for simultaneously, allowing several consultation procedures to be handled in a single application. Regulatory Development Consultation is primarily intended for first‑time interactions with PMDA regarding a product under development, though it may be used in other situations. Clinical trial consultations help applicants determine the necessity of conducting clinical studies for their SaMD products.