China CFDA clinical and testing requirements assessment

ANSWERED ON THIS PAGE:

• What are the medical device clinical data requirements in China?
• How do we determine the appropriate testing for our device?
• What if our device is considered novel or has no predicates in China?

Medical device testing and clinical data play a big role in the China medical device registration process. The China Food and Drug Administration (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 CFDA requirements for testing and clinical trials for your device and assist with registration.

Determining China's clinical conformity route for your medical device

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.

CFDA clinical data routes for medical devices

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 CFDA registration process. There are two clinical conformity routes:

Clinical Evaluation Report (CER)

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.

Clinical trial data

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 CFDA may require new clinical trials in China.

We can identify CFDA testing and clinical data requirements 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:

• Provide initial assessment to determine registration requirements (including testing requirements), and suggested clinical conformity route
• Assist with identifying qualified testing centers in China and establishing the product technical requirement
• Perform clinical literature review and prepare your CER, if needed
• Advise you regarding clinical data requirements if you must perform clinical trials in China
• Prepare registration submission documentation and submit to CFDA
• For novel devices, we can assist with preparing for the CFDA Expert Panel Review meeting

Emergo and its partner in China have the expertise to ensure a successful registration with CFDA.