Last month, we reported that the Japanese MHLW has outlined a new accelerated pilot system for SaMD products. In late October, the MHLW working group for SaMD products met with 3 groups – 1. the Japan Digital Health Alliance, 2. the Japan Medical Venture Association, and 3. the Japan Federation of Medical Devices. Discussions centered around systems to accelerate approval and reimbursement for SaMD products. Items proposed included allowing provisional approval where real-world data show good safety and efficacy or if SaMD products are used in clinical settings successfully. Also, a proposal was made to provide temporary reimbursement following provisional approval. Other suggestions included the reduction of SaMD advertising regulations.
