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Drug & Medical Device Registration

According to the Provisions of Drug Registration (July 2020) and the Administrative Measures for the Registration and Filing of Medical Device (August 2021), Jidian provides agency services for the registration or filing of imported drugs or medical devices.
Services cover: assessment, screening, selection, translation, and sorting of drug research materials, as well as testing, data submission, data supplementation, follow-up and registration certificate of imported drugs/devices.

Drug Registration Experience

We have extensive experience in registration declaration of imported drugs with profound understanding of relevant regulations and policies regarding drug registration issued by FDA, EMA and CFDA and long-term follow-up for changes of drug registration regulations and guidelines enacted by CFDA;
We have rich experience in preparation, submission and supplementation of registration application documents of human drugs. With respect to the registration applications of drugs for multiple indications, we communicate with review experts in a timely manner and conduct feasible assessment and demonstration before putting forward a final proposal to clients;
We have successfully provided clients with registration application services for more than 40 imported drugs, including clinical trial applications for new drugs (IND or CTA) and new drug application (NDA).

Medical Device Registration Experience

We have completed the registration of imported Class Ⅰ devices, as well as more than 50 registration projects for Class II and III imported medical devices , with a success rate of nearly 100%.