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.