NMPA Clinical Requirements: Clinical Evaluation Reports and Trial Alternatives in China

China NMPA Clinical Trial Requirements and Management

For most Class II and Class III medical devices entering the Chinese market, satisfying the National Medical Products Administration (NMPA) clinical requirements is the most time-consuming and expensive step. Foreign manufacturers must strategically choose their clinical pathway.

📜 Clinical Trial Exemption List

The NMPA maintains a Clinical Trial Exemption List for product types considered technologically mature with proven safety and effectiveness, or where clinical trials are deemed not feasible.

• Benefit: Devices on this list are exempt from full local clinical trials, saving considerable time and cost.
• Requirement: Even with an exemption, manufacturers must still submit a robust Clinical Evaluation Report (CER) to support the device's registration.

🔍 Alternatives to Full Local Clinical Trials

For devices not on the exemption list, manufacturers must choose one of the following primary alternatives to support their application:

1. Conduct a Local Clinical Trial: The most direct but often the most expensive and time-consuming option, requiring compliance with China's GCP standards.
2. Use Overseas Clinical Data: Manufacturers may submit clinical evidence gathered from trials outside of China. However, this data must strictly meet NMPA's local expectations and often faces challenges regarding comparability to the Chinese patient population and clinical environment.
3. Predicate Device Comparison (CER Pathway): This involves identifying at least 3 "Same Type Devices" (predicate devices) already approved in China. The manufacturer must then conduct a thorough comparison of their device to the predicates to demonstrate equivalent safety and efficacy, backed by a comprehensive Clinical Evaluation Report (CER).

📝 The Clinical Evaluation Report (CER)

The CER is a core regulatory document required by the NMPA, whether the device is exempt from trials or relies on the predicate device pathway. A complete CER generally comprises two sections:

• Device-Specific Clinical Evidence: Data collected directly by the manufacturer (e.g., non-clinical studies, usability data, clinical data).
• Literature Review: A systematic review of public information and scientific literature to provide third-party evidence that the device's underlying technology and intended uses are safe and effective.