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 and answering CFDA follow up questions. They can provide insight on how to navigate the evolving regulatory landscape in China and guide you through the CFDA regulatory process.