Launching new products in Chinese market offers tremendous opportunity for overseas medical device manufacturer, But China’s regulatory system is quite complex and there are many aspects are quite different with EU and US. Since 2014, the new regulation took effects; the threshold for market approval has been raised by high approval cost and long reviewing time. Having a partner who understands the opportunity, competitive environment of the Chinese medical device marketplace and regulatory environment is absolutely essential and can be the difference between success and failure.
With headquarter in Beijing, as a trustworthy medical devices regulatory consultant, with professional team, good and stable cooperative relationship and real-time update success cases, Xinran are here to help you obtain China Food and Drug Administration (CFDA) (formerly State Food & Drug Administration or SFDA) approval for your medical device or IVD and provide insight on how to navigate the evolving regulatory landscape in China.
Service in details
Identify device classifications in China.
Investigate and evaluate the best route to CFDA approval.
Development of the Product Technical Requirements
Follow Up Testing Procedures.
Develop clinical protocols and coordinate clinical trials, if required.
Translate documents and labeling.
Obtain CCC Mark or MOH mark, if required.
Prepare final submissions and act as official Legal Agent (LA) in China.
Device registration renewals
Class I Medical Device Filing
Class II/III Medical Device Initial Registration
Class II/III Medical Device Registration Change
Class II/III Medical Device renewal Registration
Clinical Evaluation Documents Writing
Caretaker for all your registration information and documentation