CFDA: CFDA Releases the 2015 Annual Report for Medical Device Registration

31. May 2016

Recently the CFDA released the “2015 Annual Report for Medical Device Registration”, which includes the overview of medical device registration for 2015. Overall in 2015, the CFDA has approved 7,530 registrations, with 1,297 applications being rejected. The report also includes a listing of the top device categories with medical optical instruments and endoscopic equipment being the largest category, followed by implantable materials and artificial organs, and then dental care equipment.

The report shows the origin of the registrations, with more foreign devices being registered than domestic. The conclusion could be that China to some extent, still relies on foreign supply of high-end medical devices.

The report indicates that the US, Germany, Japan, UK and Korea were among the top 5 countries which registered the highest amount of medical devices. Generally, it can be said that the 5 mentioned countries are strong players in the global medical device market.

The Chinese medical devices market has been gaining worldwide attention with an impressive annual growth rate of nearly 20% in the last decade. This growth makes the market attractive for foreign companies.

With such a large number of rejected applications, it is obvious that professional consultation is indispensable in the process of the CFDA application. MPR China Certification GmbH/China Certification Corporation can assist you with your CFDA product certification.

Please do not hesitate to call (UK: +44 2071931135, Rest of Europe: +49 69 2713769150, US: +1 773 654-2673) or e-mail and we will be happy to answer questions.