Column & Insights
医療機器の薬事申請・PMDA対応に関する実務情報や業界動向をお届けします。
Japan is the world's third-largest medical device market. This guide provides foreign manufacturers with a clear overview of Japan's regulatory approval process under the Pharmaceutical and Medical Device Act (PMD Act).
A Clinical Evaluation Report (CER) is a cornerstone document for medical device approval in Japan. This article explains the key requirements and best practices for creating an effective CER under Japan's Pharmaceutical and Medical Device Act.
Japan's PMDA offers a pre-consultation system that allows medical device manufacturers to discuss regulatory strategy before submission. Learn how to leverage this system to minimize review queries and accelerate approval.