Drug Evaluation Committee Medical Device Program (SaMD) Development Overview ~Organizing the Development Process and Development Promotion System~.
Clinical Evaluation Subcommittee
The development and utilization of digital health products, such as medical device programs (SaMD) and digital biomarkers, are becoming increasingly active in the healthcare field. The pharmaceutical industry is now considering and developing SaMD as a part of healthcare services centered on pharmaceuticals, or as a new treatment modality that can replace pharmaceuticals.
Task Force 1 of the Clinical Evaluation Subcommittee for FY2023 prepared the "Overview of SaMD Development: Development Process and Systems to Promote Development" to Explanation the SaMD development process and summarize the current status and points to note regarding the relevant systems to promote SaMD development. We hope that this document will be of some help when considering and developing SaMD.
Drug Evaluation Committee, Japan Pharmaceutical Manufacturers Association
Clinical Evaluation Subcommittee 2023 Task Force 1