New fee structure announced for medical devices in Japan
The Pharmaceuticals and Medical Devices Agency (PMDA), Japan’s regulatory body, has announced an increase in the fees payable for registration of medical devices from 1 April 2019. Three guidance documents* talk through the key changes:
- Explanation of the Japanese Ministry of Health, Labour & Welfare’s order authorising new PMDA registration fees, with related comparison tables
- Notice to Japanese regional authorities regarding implementation of revised PMDA fee structures
- Explanation of how PMDA will manage acceptance of registrations under previous versus new fee structures
The breakdown of the new fee structure is also available here*.
*Note: these documents only available in Japanese.
Find out more from Emergo’s article on the news.
