The registration process for a medical device in Japan, according to PMDA regulations, typically involves the following steps:
1. Preparation of Documentation: Prepare technical documentation, including information on the device's design, manufacturing process, materials, performance, and safety.
2. Appointment of a Marketing Authorization Holder (MAH): A MAH must be appointed if the manufacturer is based outside of Japan.
3. Application Submission: Submit the application for approval to the PMDA, including the technical documentation and information on the MAH.
4. Review by PMDA: The PMDA will review the application, including the technical documentation, to ensure compliance with Japanese regulations.
5. Quality Management System (QMS) Audit: If required, the PMDA may conduct an audit of the manufacturer's QMS to ensure it meets Japanese standards.
6. Clinical Trials: Depending on the device's classification and risk level, clinical trials may be required to demonstrate safety and efficacy.
7. Approval: If the application is approved, the PMDA will issue a marketing approval for the device.
8. Post-Market Surveillance: After approval, the device must comply with post-market surveillance requirements, including reporting of adverse events.
9. Renewal: The marketing approval must be renewed periodically, typically every five years, by submitting updated information to the PMDA.
It's important to note that the specific requirements and steps may vary depending on the classification of the device and the regulatory changes implemented by the PMDA.
