The medical and IVD device registration process for all device classifications (1, 2a, 2b and 3) must be supported by clinical and performance test reports generated by locally authorized entities (e.g., test laboratories, clinical sites, etc.).
The clinical evidence requirement may be fulfilled through a clinical trial on human subjects, or by a locally generated Clinical Evaluation Report depending on the existence of a registered predicate on the Russian market. For all IVD devices clinical trials on human samples (blood, urine etc.) is a mandatory requirement.
It is important to work with reliable, experienced consultants in Russia to efficiently manage local clinical and performance testing. Asia Actual offer a comprehensive solution to medical device registration in Russia that includes the generation of all required local clinical evidence.
Contact Asia Actual to see if our Russia Clinical and Performance Testing service is right for your business.