Medical Device Registration in Japan

The medical device market is about $25 billion in Japan. The regulator of medical devices and pharmaceuticals in Japan is the Pharmaceuticals and Medical Devices Agency (PMDA), which handles medical device and pharmaceutical registration. Other Japanese medical issues, such as hospitals, health insurance, and medical product registration policy, are handled by the Ministry of Health, Labor and Welfare (MHLW).

High-risk medical devices must be approved by the PMDA (Shonin approval), while lower-risk medical devices may apply to Notified Bodies rather than the PMDA (Ninsho approval). In addition, foreign manufacturers will need accreditation from the PMDA. To get high-risk medical devices approved, medical device companies will also need to have a quality management system (QMS) audit. Japanese regulators are very cautious in approving high-risk foreign medical device products, so the process can be lengthy.

The Japanese regulatory environment for medical devices has changed significantly since the enactment of the Pharmaceutical Affairs Law (PAL), which was implemented on April 1, 2005. The New PAL takes a step towards global harmonization, including GMP requirements based on ISO 13485 standards and Summary Technical Documentation (STED) requirements for applications for high-risk devices. One of the main changes includes replacing the In-Country Caretaker (ICC) system with a new Marketing Authorization Holder (MAH) system.

PBM can act as your designed Marketing Authorization Holder, or D-MAH.

For more information on medical device registration in Japan, please see the following PBM publications and/or contact us to discuss your specific needs.

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