Registration in Japan
Access to the Japanese market
To register a medical device in Japan, manufacturers must obtain approval from the Pharmaceuticals and Medical Devices Agency (PMDA) and follow a structured process that includes:
Device classification
Appointment of a Marketing Authorization Holder (MAH)
Submission of compliance documentation
Implementation of a Quality Management System (QMS)
Device evaluation is categorized as New Medical Devices, Improved Medical Devices, or Me-too Devices, depending on whether similar devices are already approved in Japan.
The MAH submits the application to the PMDA (or to a Recognized Certification Body – RCB, depending on the device class and type). The PMDA or RCB will review the application and, if necessary, conduct a QMS audit, unless the manufacturer holds a valid MDSAP certificate covering Japan.
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