日本醫療器材註冊：途徑與要求

In Japan, regulatory approval and reimbursement are separate hurdles. Most devices fall into A1 or A2 (covered under existing procedure fees). However, if your device is a breakthrough technology, you may apply for a C1 (New Function) or C2 (New Category) listing. This is a complex negotiation with the MHLW that happens after approval. The price is determined based on a "Cost Calculation Method" or "Comparison with Similar Devices." We advise starting the reimbursement strategy during the PMDA review phase to minimize the "lag time" between approval and the first sale.

Under the PMD Act, the Marketing Authorization Holder (MAH) or DMAH is the legal owner of the registration. If your distributor acts as the MAH, they control your "market access." By appointing an independent DMAH (like a third-party service), you retain control of the license. The DMAH acts as your regulatory anchor in Japan, allowing you to appoint and manage multiple "Sellers" (distributors) without needing to re-register the product if you terminate a sales partnership.

Japan has become more flexible via the "Global Clinical Trial" framework, but the PMDA still evaluates "Ethnic Factors" (as per ICH E5 guidelines). For high-risk devices (Class IV), the PMDA will look at whether the Japanese population's physical dimensions or metabolism could lead to different safety outcomes. In many cases, if you can provide a scientific justification that the "ethnic factors" are negligible, you can avoid a domestic trial. We highly recommend a PMDA Pre-submission Consultation to confirm if your US/EU data is sufficient before you file.

Yes, SaMD has been regulated as a medical device in Japan since 2014. The pathway depends on "JMDN" (Japanese Medical Device Nomenclature) codes. If a "Third-Party Certification" (Ninsho) standard exists for your specific software type (Class II), the process is faster (approx. 4–6 months). However, for innovative AI diagnostic tools that don't fit existing codes, you must go through the "PMDA Approval" (Shonin) route (Class III), which requires a more rigorous review of your clinical algorithm and potentially a consultation meeting with the PMDA to agree on the evaluation criteria.