The fees and costs for registration of medical devices in Japan can vary depending on several factors, including the classification of the device, the type of application, and the services required. Some of the key fees and costs associated with medical device registration in Japan include:
1. Registration Fee: This fee is required for the review and processing of the registration application. The amount varies depending on the classification of the device and the type of application.
2. Quality Management System (QMS) Audit Fee: If a QMS audit is required as part of the registration process, there may be additional fees for the audit.
3. Consultation Meeting Fee: If manufacturers request consultation meetings with the PMDA before submitting the application, there may be fees associated with these meetings.
4. Translation Costs: If documents need to be translated into Japanese, there will be costs associated with translation services.
5. Local Representative Fee: If a local representative is required, there may be fees associated with their services.
6. Post-Market Surveillance Fees: After approval, manufacturers are required to conduct post-market surveillance, which may involve additional costs.
7. Renewal Fees: The marketing approval must be renewed periodically, typically every five years, and there are fees associated with the renewal process.
It's important for manufacturers to budget for these fees and costs when planning to register a medical device in Japan. The exact fees and costs can vary, so it's advisable to consult with regulatory experts or local representatives for more specific information.
Please note that these fees are subject to change based on the TFDA’s announcements and the exchange rate. For more detailed information, you may want to visit the official website of the Pharmaceuticals and Medical Devices Agency (PMDA) or speak with Artixio Expert.
