[Guidelines on medical devices vigilance system of European Commission & its enlightenment to China].
This paper introduces the guidelines on medical devices vigilance system of European Commission and the duty of parties involved. It provides reference for establishing medical devices vigilance system and strengthening regulation of medical devices in our country.
Tang
Han
H
School of Business and Administration, Shenyang Pharmaceutical University, Shenyang, 110006. tanghan_1986@163.com
Linghu
Chang-li
CL
Yang
Yue
Y
D002681:China; D004869:Equipment Safety / Q000379:methods* / Q000592:standards; D005062:European Union; D017408:Guidelines as Topic; D011358:Product Surveillance, Postmarketing / Q000592:standards*