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China CFDA Medical Device Registration and Approval

ANSWERED ON THIS PAGE:

  • How are medical devices classified in China?
  • Does the China Food and Drug Administration require medical device testing?
  • Do foreign medical device companies need in-country representation in China?

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. Our experienced consultants can provide insight on how to navigate the evolving regulatory landscape in China and guide you through the CFDA regulatory process.

Medical device and IVD registration in China

Medical devices are regulated by the China Food and Drug Administration (CFDA). Manufacturers must register their devices with the CFDA before selling or distributing in China. The CFDA reviews all device applications, and has strict requirements for submission documentation, testing, and clinical data.

CFDA medical device registration submissions and device classification

Your device classification determines the documentation required for your CFDA submission. Classification is based on CFDA Order 15 and the CFDA classification database. Device classification and their registration requirements are as follows:

  • Class I – registration dossier – no testing reports
  • Class II – full registration dossier and technical review
  • Class III – full registration dossier and technical review

Manufacturers must submit a technical dossier that includes detailed technical information, clinical data, and quality documentation. China requires in-country testing for all Class II and III devices, although the CFDA may accept some of your existing testing reports. Testing requirements vary depending on your device type.

Let Emergo help you with China medical device regulatory issues

Emergo can help you obtain regulatory approval for your medical device or IVD in China. Our specialists work directly with the CFDA on a daily basis, coordinating the submission of regulatory documents and answering CFDA follow-up questions.

  • 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.

China is a challenging market, but our colleagues in China have the regulatory experience to help you succeed.

 

Common questions

Is in-country representation required for foreign manufacturers selling in China?

Yes. In fact, foreign manufacturers without an office in China need to appoint two in-country representatives. The first is known simply as an Agent. They will manage your registration and communicate with the CFDA before and after registration, and during vigilance reporting. Even though your Agent’s name appears on your registration certificate, you will own the registration. You’ll also need to appoint an After Sales Service Provider responsible for your device after CFDA approval. Most manufacturers appoint a distributor.

Do we need to include proof of home-country approval with our CFDA device submission?

Yes. You are required to show proof of home country approval with a Certificate of Free Sale or Certificate to Foreign Government.

How long does the CFDA registration process take?

It varies by device and classification, but we have a useful chart on our website that shows the timelines and explains the entire process. Responding quickly to CFDA requests for additional information or testing to minimize your registration time.