Similar logic, different comparator rules

NMPA’s same-variety clinical evaluation is structurally closer to FDA’s predicate logic than to the MDR approach. Both compare the subject device with another device, not with the whole device field. Manufacturers therefore ask whether the substantial equivalence work done for FDA can go straight into an NMPA submission.

A 510(k) compares the technical characteristics and intended use of the subject device with a predicate device legally marketed in the US. FDA clears the device once it finds the two substantially equivalent. The predicate only needs to be legally marketed in the US. It does not need any regulatory status in China.

Why the FDA predicate may not qualify

NMPA’s same-variety route requires a comparator that meets Chinese regulatory requirements and is already legally marketed in China. If the FDA predicate was never registered or marketed in China, it cannot serve directly as the comparator in an NMPA same-variety evaluation.

This has nothing to do with the quality of the clinical data. The comparator simply has no regulatory status in China. The manufacturer then needs another clinical evaluation route, or another same-variety comparator that is registered in China.

What the FDA data can still do

The clinical data generated during the FDA submission keep their value. Clinical trial data and other relevant clinical evidence can be used in an NMPA clinical evaluation under the Technical Guideline for Accepting Overseas Clinical Trial Data for Medical Devices.

The assessment checks whether the data are authentic, scientific, complete and sufficient. It also checks whether differences in study population, disease characteristics, medical practice and review requirements affect how the data apply to China.

Overseas clinical trial data do not have to form a separate route. Depending on the product and the evaluation strategy, they can also support the evaluation of differences found in a same-variety comparison.

Plan the role of the data early

The decision to plan early is how the FDA data enter the NMPA submission. They can support a same-variety comparison, be used directly as overseas clinical trial data, or do both. The question is not whether FDA-accepted data can be carried over. The question is what role the data should play within the NMPA clinical evaluation framework.