Entering the Chinese market offers tremendous opportunity for medical device companies, but it is not without challenges. Having a partner with experience and expertise in the Chinese marketplace is essential. It can be the difference between success and failure.
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.
- Compile the registration application and Technical Requirement document.
- Coordinate product testing in China.
- Prepare final submissions.
- Handle CFDA Supplementary Notice requests (additional information inquiries from the DVDA) and device registration renewals.
Please contact us for more information on obtaining CFDA approval for your medical device in China.