Meeting with the CFDA on Registration Fees for Medical Devices

2015-04-17 | Beijing, Shanghai

A delegation of the HCE Working Group of the EUCCC visited the CFDA, represented by officers from the Finance Planning Dept., the Department of Medical Device Registration, the Center of Medical Device Evaluation and the Centre for Food and Drug Inspection.

Imposition of registration fees will be based on a law to be promulgated by the State Council. The decision on structure and amount of registration fees is jointly made by the NDRC, the MoF and CFDA. The registration fees are one element of the overall reform of the registration process that started in 2014.

Both sides exchanges opinions and suggestions on details of the planned registration fees.

The registration fees for imported medical devices will cover the expenses for factory audits outside of China. Regulations on the audit procedure outside of China shall be promulgated in 2015.