【CODEX】医疗器械生产监督管理办法（5-7）-EN
第五章 监督管理
Chapter V Supervision and Administration
第五十条 食品药品监督管理部门依照风险管理原则，对医疗器械生产实施分类分级管理。
Article 50.The food and drug regulatory authorities shall conduct classified and graded administration on medical device manufacturing in accordance with principles of risk management.
第五十一条 省、自治区、直辖市食品药品监督管理部门应当编制本行政区域的医疗器械生产企业监督检查计划，确定医疗器械监管的重点、检查频次和覆盖率，并监督实施。
Article 51.The food and drug regulatory authorities of provinces, autonomous regions or municipalities directly under the Central Government shall prepare a plan for supervision and inspection on medical device manufacturers within its administrative region and determine key points, frequency of inspection as well as coverage rate of medical device supervision, and supervise the implementation.
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