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April 26, 2024
Approximately 5 minutes
Predicate Device Identification in China: Navigating the 'Same-Type' Requirement for NMPA Approval
Predicate Device Identification in China (Same-Type Devices)
In China, Predicate Device Identification, locally referred to as 'Same-Type' devices, is a critical regulatory strategy for Class II and Class III medical device manufacturers. Successfully identifying and comparing a device to an already-approved predicate can often exempt the product from costly and time-consuming local clinical trials.
🔍 The Role of Predicate Devices
The core function of identifying a predicate device is to demonstrate the applicant's product is substantially equivalent in terms of safety and efficacy to a device already legally marketed in China.
- Clinical Trial Avoidance: If equivalence can be proven, manufacturers can submit a Clinical Evaluation Report (CER) in lieu of a full clinical trial.
- Narrow Definition: The NMPA maintains a very narrow definition of a "Same-Type Device." Products must share similar technology, the same indications for use, and sometimes even the same raw materials (e.g., a drug-eluting stent must use the same drug in similar quantities as its predicate).
📝 The Clinical Evaluation Report (CER)
The CER is the required document used to support a "Same-Type" device claim. It must include:
- Thorough Comparison: A detailed comparison of the applicant device against the identified predicate device(s) across critical performance, structural, and intended use parameters.
- Clinical Evidence: A summary of clinical and non-clinical data, coupled with a systematic literature review, to prove that the device is safe and effective in the intended clinical setting.
❓ Clarifying NMPA Expectations
Historically, manufacturers faced uncertainty regarding whether their product would be considered "Same-Type" until the formal review began. To improve transparency, the NMPA established a mechanism for pre-submission inquiries:
- Formal Inquiry Process: Manufacturers can seek feedback from the NMPA on the specific performance parameters and data the agency will expect for a Same-Type Device application. This process is designed to reduce the previous turnaround time from approximately six months to about two months, providing essential clarity for regulatory planning.
📜 Clinical Trial Exemption List
While the predicate pathway is a key alternative, the NMPA also maintains an Exemption List for certain product types whose technology is considered mature and has a proven history of safety. Products on this list are automatically exempt from clinical trials but still require the submission of a CER.
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