China CFDA (SFDA) Approval for Medical Devices

See all regulatory consulting services and medical device registration services.

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

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

• Determine device classification.
• Ascertain the best route to CFDA 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, CFDA inspections and device registration renewals.

Please contact us for more information on obtaining CFDA SFDA approval for your medical device in China.