Japan’s Import Notification Requirements for Medical Devices Changing in 2016

Japanese Import Notification requirements currently in place for foreign medical devices and drugs registered for sale in the country expired at the end of 2015, and have been replaced by a new importation system starting January 1, 2016.

Japan import notification rule changes for foreign medical device manufacturers and D-MAHAccording to an announcement by Japan’s Ministry of Health, Labour and Welfare (MHLW), medical device manufacturers’ Marketing Authorization Holders (MAH) or Designated Marketing Authorization Holders (D-MAH) will be required to submit copies of their MAH licenses to customs officials for clearance.

For devices already registered for sale in Japan, copies of premarket approvals, premarket certifications or premarket submissions must also be provided to customs officials. For unregistered devices under review by the Pharmaceuticals and Medical Devices Agency (PMDA) or a Registered Certification Body (RCB), MAHs and D-MAHs must also submit copies of premarket approval, certification or submission applications bearing receipt stamps from either the PMDA or RCB.

Foreign medical device manufacturers active in the Japanese market should verify that their D-MAH partners are aware of these import notification changes.

Additional Japanese regulatory information available from Emergo includes a whitepaper on the Pharmaceutical and Medical Devices Law and a process chart on the country’s device approval process.

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