China SFDA Approval for Medical Devices

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Entering the Chinese market offers tremendous opportunity for medical device companies, but it is not without risk. Having a partner who understands the opportunity and competitive environment of the Chinese marketplace is absolutely essential and can be the difference between success and failure.

Through our office in Beijing, Emergo Group can help you obtain State Food & Drug Administration (SFDA) approval for your medical device or IVD. Our specialists in Beijing work directly with the SFDA on a daily basis, coordinating the submission of regulatory documents, answering SFDA follow up questions and providing insight on how to navigate the evolving regulatory landscape in China.

Let Emergo Group help you with these China medical device regulatory issues:

Determine device classification.
Ascertain the best route to SFDA approval in China.
Development of a Product Registration Standard.
Develop clinical protocols and coordinate clinical trials, if required.
Translate documents and labeling.
Obtain the CCC Mark, if required.
Prepare final submissions and act as official Legal Agent and After Sales Agent in China.
Handle incident reporting, SFDA inspections and device registration renewals.