Japan’s Ministry of Health, Labor and Welfare (MHLW) recently published in English, a draft regulation on the requirements for marketing authorization approval for in vitro diagnostics (IVD). The MHLW will evaluate the purpose of use, principle, structure, shape, category specifications, usage, etc. of an IVD and grant approval based on one of four categories. These categories are as follows: (1) new product, where the applicant is detecting or measuring a new item; (2) approval criteria, for which approval criteria are already established and the application meets these criteria; (3) non-approval criteria, when no approval criteria have been established; and (4) non-conformity, in the case where the IVD does not meet the appropriate criteria for its category.
The application for marketing authorization approval must also include supporting documents that can ensure the scientific soundness, ethics and reliability of the IVD. The required documents vary by product category and will include some or all of the following information: (1) course of discovery and usage status overseas, (2) setting the specifications, (3) stability, (4) performance, (5) risk analysis, (6) manufacturing methodology, and (7) clinical studies. While the categories and requirements are only based on a draft regulation, it shows the direction the MHLW is taking with IVDs in Japan. To see the full draft regulation in English, please visit our website at www.pacificbridgemedical.com, then click on Publications and Japan.