About us

Medical device registration is the process by which the regulatory authorities of the food and drug administration department evaluate the safety and effectiveness of a medical device that is proposed for marketing by the applicant, and determine whether to approve the application based on a statutory procedure.

The Innovative Medical Device Registration Research and Clinical Transformation Service Center is a specialized organization dedicated to supporting the registration and clinical translation of innovative medical devices in China. It was established in November 2020 and has a focus on the clinical transformation of the biopharmaceutical industry.

The center operates on a "production, learning, research, medical, management and use" model, which integrates "research and transformation". It covers the full lifecycle management of pharmaceutical and medical device product development, clinical trials, and registration. The center has extensive experience in research and development and has established long-term collaborations with well-known scientific research institutions, third-party testing organizations, and medical device associations at all levels.

The center aims to provide professional, engineering, and industrial technology development services that are sound in mechanism, compliant in process, rigorous, efficient, and innovative, in order to support the translation of innovative medical devices. The center has successfully completed the first case of a 3D-printed medical device registration under the medical device registration system for research institutions, and has participated in the formulation of multiple 3D-printed medical device standards in China.