Globally, Japan is renowned for its technological innovations and stands as one of the largest markets for healthcare and medical devices. The Japanese medical device market is stringently regulated, with enforced regulations ensuring the safety and effectiveness of medical devices while also promoting innovation within the industry. This whitepaper provides a comprehensive overview of the medical device industry landscape in Japan, detailing the classification system and various regulatory pathways for device registration. Additionally, the whitepaper addresses Quality Management Systems (QMS), Foreign Manufacturing Registration (FMR), and Marketing Authorization Holder (MAH/DMAH) requirements for medical devices.
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