[Ideas about registration for sodium hyaluronate facial derma fillers].
OBJECTIVE
To review the registration and technical data for sodium hyaluronate facial derma fillers.


METHODS
Recent literature concerning registration for sodium hyaluronate facial derma fillers was reviewed and analyzed.


RESULTS
The 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.


CONCLUSIONS
The 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.
Center for Medical Device Evaluation, State Food and Drug Administration, Beijing 100044, PR China.
Peng
P
Zhao
Xinli
X
Shi
Wenbo
W
Liu
Hong
H
Lu
D001672:Biocompatible Materials / Q000592:standards*; D003357:Cosmetic Techniques; D005145:Face; D006801:Humans; D006820:Hyaluronic Acid / Q000008:administration & dosage* / Q000592:standards*; D007267:Injections; D011786:Quality Control; D012042:Registries; D012449:Safety
D001672:Biocompatible Materials; D006820:Hyaluronic Acid