Regenerative Medical Products Approval and Review Process
PMDA regulatory framework for approval and post-market review of regenerative medical products. Includes list of approved products and review reports for regenerative medicine applications.
Manufacturers and sponsors placing medical devices on the Japan market should review their current compliance documentation against this change. Assess whether your device class, labelling, registration status, or technical documentation is affected. Where gaps are identified, update your files and notify your local representative or importer. Refer to the official source below for the full regulatory text and any transitional arrangements.
View official source ↗