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.