Japan’s PMDA FY 2024 Plan Expedites SaMD Review

At a March 13 PMDA meeting, the priority review time for SaMD products was set at 6 months. SaMD products with strong effectiveness will enjoy SaMD priority review if the SaMD product is submitted first in Japan or simultaneously with other global markets. This PMDA meeting recommendation was a result of its success during the previous pilot program.

The SaMD system was introduced on a pilot basis in September 2022. The title of this pilot program was — “Trial Implementation of Priority Review for Program Medical Devices”. In Japanese, program medical devices are the same as SaMD.

Program medical devices or SaMD products that could apply had to meet the following requirements.

(1) Requirement 1: Innovative treatment, diagnostic or preventive method

Basically, the principle of a SaMD program medical device should be clearly different from that of existing medical devices.

(2) Requirement 2: Medical usefulness for the target disease. Must fall under any of the following: there is no existing therapeutic, prophylactic, or diagnostic method, or the efficacy or safety is expected to be significantly higher than that of the existing therapeutic, prophylactic, or diagnostic methods in clinical trials, etc.

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.pmda.go.jp/files/000250261.pdf