The regulatory process for medical devices in Japan involves several key steps:
1) Classifying the device and appointing a Marketing Authorization Holder who will manage the registration process.
2) Implementing a Quality Management System that complies with relevant regulations.
3) Submitting an application to either the Pharmaceuticals and Medical Devices Agency or a Registered Certification Body, depending on the device class.
4) Undergoing an audit and receiving the appropriate certificate before marketing the device in Japan. Device registrations do not expire but must be renewed periodically.