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 China, Emergo can help you obtain China Food and Drug Administration (CFDA) approval for your medical device or IVD. Our specialists 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.
Let Emergo help you with China medical device regulatory issues:
- Determine device classification.
- Determine if clinical trials will be needed for your device.
- Ascertain the best route to CFDA approval in China.
- Development of a Product Registration Standard.
- Prepare final submissions.
- Handle incident reporting, CFDA inspections and device registration renewals.