Why Choose Us
By choosing MRC, you are choosing to partner a dedicated professional team who is committed to provide customized professional consulting services of regulatory affairs to your operations.
Beijing MRC Medical Consulting Co., Ltd. has over 10 years experience on medical device regulatory consulting service in China. We help over 300 medical device companies access Chinese medical device market. Our consultants can offer holistic solutions to optimize the registration strategy.
Highest levels of expertise
As we only dedicate to Chinese medical device regulatory affairs, we have sufficient knowledge and understanding on it. Our experienced consultants can comprehensively assist you to fully understand CFDA medical device regulations, corresponding guidance and procedures.
Good management system, one on one tailored service can make you easily control your project status and access to Chinese market quickly.
China CFDA Now Charges MD and Drug Registration
Starting from May 27, 2015, the China CFDA now charges the registration of medical devices and drug (CFDA Announcement No. 53 in 2015).
This says, many foreign enterprises that are aiming at Chinese market are facing higher budget pressure for regulatory affairs, since there is no cost for administration at all.
We see clearly a cost difference between the imported and domestic medical device, which is due to the cost for travelling, accommodation and meals of CFDA auditors in/outside China.
This indicates that the CFDA is developing an oversea auditing strategy for better control of quality management system as the US FDA does.
However, it would still take some time for the industry to find out how the CFDA audit will be performed, given that the strict overseas travel regulation of Chinese administrators and the language requirement of the CFDA auditors.