中国医疗器械杂志
中國醫療器械雜誌
중국의료기계잡지
CHINESE JOURNAL OF MEDICAL INSTRUMENTATION
2014年
4期
287-289
,共3页
医疗器械%风险管理%生产和生产后
醫療器械%風險管理%生產和生產後
의료기계%풍험관리%생산화생산후
medical device%risk management%production and after-production
该文通过对我国医疗器械上市后风险管理法规及现状分析，阐述了生产和生产后信息问题清单及风险分析流程，同时对我国医疗器械上市后风险管理方面给出几点建议，希望对生产企业和监管人员能起到一定指导作用。
該文通過對我國醫療器械上市後風險管理法規及現狀分析，闡述瞭生產和生產後信息問題清單及風險分析流程，同時對我國醫療器械上市後風險管理方麵給齣幾點建議，希望對生產企業和鑑管人員能起到一定指導作用。
해문통과대아국의료기계상시후풍험관리법규급현상분석，천술료생산화생산후신식문제청단급풍험분석류정，동시대아국의료기계상시후풍험관리방면급출궤점건의，희망대생산기업화감관인원능기도일정지도작용。
By analysis on the risk management regulations and the situation of medical device after the product on the market, information list of problems and risk analysis process of the production and after-production were described, simultaneously, the suggestions were put forward to risk management after the product on the market, with the aim of providing reference for manufacturers and administrators.
