As noted in our June Pacific Bridge Medical Newsletter, Japan is planning to implement a two-step registration process for SaMD products in early 2024. If a SaMD product shows strong safety and efficacy, it will get initial approval. Later, if the SaMD shows safety and efficacy in clinical use or during a post-market study, a second approval will be granted.
To facilitate this process, the PMDA will enlarge its existing SaMD review staff. In addition, a brand-new subscription-type service will be established to allow SaMD manufacturers access to multiple consultation sessions in a fixed time frame with the SaMD review staff. New guidelines will outline SaMD priority review options and ways to accommodate partial changes to the SaMD products in a timely manner. These changes are part of what the PMDA calls its “Dash for SaMD2” program. This program is geared towards helping Japan catch up with the Western countries with respect to SaMD registration and use.
Written by: Ames Gross – President and Founder, Pacific Bridge Medical (PBM)
Mr. Gross founded PBM in 1988 and has helped hundreds of medical companies with regulatory and business development issues in Asia. He is recognized nationally and internationally as a leader in the Asian medical markets. Mr. Gross has a BA degree, Phi Beta Kappa, from the University of Pennsylvania and an MBA from Columbia University.
Source used in the article: https://www.trade.gov/market-intelligence/japan-software-medical-device-samd