ZHAO Peng , SHI Xinli , LIU Wenbo , LU Hong.
  • Center for Medical Device Evaluation, State Food and Drug Administration, Beijing, 100044, P.R.China. Corresponding author: SHI Xinli, E-mail: shixl@cmde.org.cn;
Sodium hyaluronate; Facial derma filler; Registration; Technical data; Standard; Specification
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ObjectiveTo review the registration and technical data for sodium hyaluronate facial derma fillers. MethodsRecent literature concerning registration for sodium hyaluronate facial derma fillers was reviewed and analyzed. ResultsThe aspects on registration for sodium hyaluronate facial derma fillers include nominating the product, dividing registration unit, filling in a registration application form, preparing the technical data, developing the standard, and developing a registration specification. ConclusionThe main difficulty in registration is how to prepare the research data of that product, so the manufacturers need to enhance their basic research ability and work out a scientific technique routing which could ensure the safety and effectiveness of the product, also help to set up the supportive documents to medical device registration.

Citation： ZHAO Peng,SHI Xinli,LIU Wenbo,LU Hong.. IDEAS ABOUT REGISTRATION FOR SODIUM HYALURONATE FACIAL DERMA FILLERS. Chinese Journal of Reparative and Reconstructive Surgery, 2012, 26(9): 1134-1137. doi: Copy