Answer: It is not a mandatory requirement. NMPA offers multiple clinical evaluation pathways:

Catalogue of Devices Exempt from Clinical Evaluation: If your product is listed in the Catalogue of Medical Devices Exempt from Clinical Evaluation, you may submit comparative supporting documents.

Equivalent Product Comparison: Demonstrate safety and efficacy by comparing clinical data of already marketed equivalent medical devices.

Domestic Clinical Trials: Mandatory only when no equivalent product data is available, or if the product features major innovations or carries high risks. We will design the most cost-effective and time-efficient clinical strategy tailored to your product characteristics.