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.
ObjectiveTo review the registration and technical data for breast implants. MethodsRecent literature concerning registration for breast implants was reviewed and analyzed. ResultsThe aspects on registration for breast implants are complicated. The major aspects include providing technical data, establishing develop standard, progress type test, and developing the registration specification. ConclusionThe manufacturers need to be well aware of the risk of this kind of product and have the full ability to conduct the researching and developing. Only the strict risk controlling can ensure the safety and effectiveness of the product.