[Ideas about registration for breast implants].
OBJECTIVE
To review the registration and technical data for breast implants.


METHODS
Recent literature concerning registration for breast implants was reviewed and analyzed.


RESULTS
The 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.


CONCLUSIONS
The 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.
Center for Medical Device Evaluation, State Food and Drug Administration, Beijing 100044, PR China.
Peng
P
Zhao
Xinli
X
Shi
Wenbo
W
Liu
D018427:Breast Implants / Q000592:standards* / Q000706:statistics & numerical data*; D018795:Device Approval / Q000592:standards; D005260:Female; D006801:Humans; D011474:Prosthesis Design; D011786:Quality Control; D012042:Registries; D015203:Reproducibility of Results; D012449:Safety; D020034:Silicone Gels; D012841:Simethicone
D020034:Silicone Gels; D012841:Simethicone