ANSWERED ON THIS PAGE:
Medical device testing and clinical data play a big role in the China medical device registration process. The National Medical Products Administration (NMPA) - formerly the China Food and Drug Administration or CFDA - requires in-country testing and extensive clinical data for most medical devices. Understanding those requirements is challenging even for an experienced QA/RA professional. Emergo can provide a detailed assessment of the NMPA requirements for testing and clinical trials for your device and assist with registration.
All Class II and III medical devices distributed in China require in-country testing that meets the Technical Requirement for that device. Class II and III devices also require clinical data, unless your device is on the Clinical Trial Exemption list. To confirm your device's exemption status, it must exactly match the Exemption List product code and intended use.
It's important to understand if your existing clinical data will be accepted before beginning registration. If your product is not exempt, you must provide a Clinical Evaluation Report (CER) or clinical trial data. In some cases, you may need to conduct a clinical investigation in China to meet the CFDA's clinical data requirements. Identifying your route to conformity up front will save you time, resources, and frustration during the NMPA registration process. There are two clinical conformity routes:
The CER must compare your product to an equivalent device on the Chinese market, proving substantial equivalence with detailed legal and technical information that is not public (i.e. actual manufacturing process for the predicate device, exact material specifics, etc.). In reality, it is very difficult to meet this requirement unless your company owns the predicate device.
If you cannot supply the necessary predicate data, or identify an equivalent device on the Chinese market, you must submit clinical trial data for your device. The data can be from an existing trial conducted outside of China but your study must comply with China Good Clinical Practice (GCP) and must be applicable to the Chinese patient population, among other requirements. Otherwise, the NMPA may require new clinical trials in China.
Emergo is fully equipped to help you comply with Chinese testing and clinical conformity requirements for your device before you start the registration process. Here's how we can help:
Emergo and its partner in China have the expertise to ensure a successful registration with NMPA.