Medical device product registration and importation in China requires a Medical Device Registration Certificate (MDRC) issued by the National Medical Products Administration (NMPA), previously the China Food and Drug Administration (CFDA). This document is technically owned by the foreign manufacturer, but is controlled by the Legal Agent listed on the certificate who is responsible for the registration application. Products must have home country approval prior to applying for registration in China.

Medical device registration in China is now valid for 5 years (previously it was valid for only 4 years). If a manufacturer wants to renew a device’s registration, a renewal application should be submitted 6 months prior to the expiration date and can now be submitted online through the new Electronic Regulated Product Submission (eRPS) system, along with all new applications.

MEDICAL DEVICE CLASSIFICATION

Low Risk Class I medical devices are subject to a filing process with applications submitted to the NMPA. Administrative review and MDRC issuance takes about 4 weeks from application submission.

Medium Risk Class II and High Risk Class III medical devices are subject to a registration process with applications and supporting documentation submitted to the NMPA. Product testing certificates issued from a (local) NMPA-certified laboratory are a required element of the application. Local clinical test data is also required for most Class II and III devices

“SAME TYPE DEVICE” AND CLINICAL REQUIREMENTS

In recent years, some foreign manufacturers have become frustrated with China’s regulatory requirements due to their inability to understand, and plan for, what will be needed during the application process. One of the primary uncertainties is whether a device will require local clinical trials. Previously, the NMPA (CFDA at the time) were more lenient with clinical requirements and would accept Clinical Evaluation Reports (CERs) in lieu of clinical trials, thus reducing the registration costs significantly. However, as the Chinese medical device industry continues to rapidly expand, the NMPA has sought more oversight. When combined with their very narrow definition of a predicate, or locally known as “same type device,” it can be difficult for foreign manufacturers to determine ahead of time how their product will be evaluated. 

In order to alleviate some of the uncertainty facing manufacturers of same type devices, the NMPA published a notification (link in Chinese) in the summer of 2019 outlining the formal process for seeking the performance parameters the NMPA would expect during the product’s application process. While there previously had been a mechanism for asking the CFDA about this issue, the new process is more transparent and is expected to cut the turnaround time from about 6 months to 2 months. Depending on the NMPA’s feedback, manufacturers can then compile a Clinical Evaluation Report (CER) in lieu of a Clinical Trial to support their same type device claim. 

DOCUMENT REQUIREMENTS

If a medical device company wants to register a device that is not manufactured in China, it is required that the company provide device samples to the NMPA for testing. 

In the case of registering Class II and Class III devices, manufacturers are obligated to submit the appropriate documents showing that the device has been approved in its country of origin (i.e. CE Mark, 510(k) letter, ISO 13485 certification, approved Premarket Approval Application). It may also be required to provide supportive clinical data along with the application. All product information on packaging and labeling must be translated to Simplified Chinese. 

Foreign manufacturers must also hire China-based agents that will represent their interests in China. The responsibilities of the designated agents include providing technical service and maintenance support for the device, assisting with device recall (if recall is required), overseeing the registration process, and providing support for the manufacturer in case adverse events occur due to device malfunction. 

License Transfer

It takes about 2 months to transfer a China Legal Agent. The annual service fee for a China Legal Agent transfer is USD 4,000 per/product/year. below is a document list, that will need to be signed and notarized. The client only needs to provide the scan copy of the NMPA registration certificate.

1. Application Table
2. Declaration of Standard Conformity
3. Declaration of Authenticity
4. Declaration of Conformity
5. Letter of Authorization for Legal Agent
6. Letter of Undertaking by Legal Agent
7. Copy of l registration certificate and its attachment, copy of previous change documents
8. Declaration of Change
9. Declaration of Legal Agent Change
10. Copy of Business License of Agent

Contact Asia Actual for a free consultation discussing the potential for your medical device or IVD in the Chinese market.  Asia Actual is available to help navigate the complex medical device registration requirements and regulatory pathway for medical device and IVD distribution in China.