Japan has been slow to approve SaMDs but hopes to finalize its registration system for these products in 2024. On May 29, after a working group session that included the PMDA and Chuikyo (Japan’s reimbursement agency) to discuss SaMD registration, a guidance document was issued. In this guidance document, Japan’s Ministry said that if legal and risk requirements are met, SaMD products in Japan may be registered in a two-step process. First, if the SaMD product shows efficacy, it can get an initial approval. Second, as the SaMD product shows its safety and efficacy via its clinical use and via a post-marketing clinical study, the SaMD manufacturer can then submit another supplementary application to get a second approval. This two-step process would enable more SaMD products to get on the Japanese market more quickly to help patients.
In the guidance document, diagnostics, therapeutic, and preventative SaMD products have different registration requirements. For example, therapeutic SaMDs need to show that they can reduce patients’ symptoms via non-clinical studies, there is no treatment available for a specific disease, etc. This guidance document only represents the start of implementing the two-stage approval system for SaMD products. More PMDA and other relevant committee meetings will be necessary to finalize this SaMD program.