Substantial Equivalence (同品种临床评价)
In China, the equivalent to a US 510(k) predicate comparison or an EU MDR equivalence claim is the same-kind clinical evaluation (同品种临床评价). This pathway allows an applicant to leverage clinical data from one or more already-registered predicate devices instead of conducting a new clinical trial.
Equivalence criteria
Equivalence must be demonstrated across three dimensions:
| Dimension | What must be shown |
|---|---|
| Technical characteristics | Same or equivalent materials, dimensions, energy output, surface coatings, sterility status, and manufacturing methods |
| Biological characteristics | Same or equivalent biological contact (duration, tissue type), biocompatibility profile |
| Clinical characteristics | Same intended use, same indication, same target patient population, same anatomical site of use |
All three dimensions must be satisfied. Equivalence in one or two dimensions is insufficient.
Data access requirements
NMPA requires that the applicant either:
- Owns the clinical data from the predicate device (i.e. the applicant is also the registrant of the predicate, or has a contractual right to the data), or
- Relies on published peer-reviewed literature covering the predicate's clinical performance
Unlike the FDA, NMPA does not have a system for applicants to cross-reference a competitor's registration file without data access. If data cannot be accessed, a clinical trial may be the only option.
Predicate selection
The predicate device must be:
- Currently registered with NMPA (valid registration certificate)
- In the same NMDCC product category
- Used clinically in China (not solely a foreign device)
Multiple predicates may be used if no single device satisfies all equivalence criteria, but this increases the complexity of the evaluation.
Content on this site is written with AI assistance and is intended as a navigation aid only. Always verify against official NMPA sources before making regulatory decisions. Not affiliated with NMPA or any Chinese Government body. Not legal or regulatory advice.