ANSWERED ON THIS PAGE:
- How are medical devices classified in China?
- Does China 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 regulatory process.
Medical device and IVD registration in China
Medical devices are regulated by the National Medical Product Administration (NMPA), formerly the China Food and Drug Administration or CFDA. Manufacturers must register their devices with the NMPA before selling or distributing in China. The NMPA reviews all device applications, and has strict requirements for submission documentation, testing, and clinical data.
China medical device registration submissions and device classification
Your device classification determines the documentation required for your NMPA submission. Classification is based on NMPA Order 15 and the NMPA 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 NMPA 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 NMPA on a daily basis, coordinating the submission of regulatory documents and answering NMPA follow-up questions.
- Determine device classification.
- Determine if clinical trials will be needed for your device.
- Ascertain the best route to NMPA approval in China.
- Compile the registration application and Technical Requirement document.
- Coordinate product testing in China.
- Prepare final submissions.
- Handle Supplementary Notice requests (additional information inquiries from the DVDA) and device registration renewals.
- For manufacturers, Emergo by UL can act as your China Agent representative.
China is a challenging market, but our colleagues in China have the regulatory experience to help you succeed.
Common questions regarding China's medical device registration and approval
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 NMPA 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 NMPA approval. Most manufacturers appoint a distributor.
Do we need to include proof of home-country approval with our NMPA 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 NMPA 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 NMPA requests for additional information or testing to minimize your registration time.