| Notice of the Department of General Administration of the National Medical Products Administration on Implementing the Reform Measures for “Separating Permits from Business Licenses” and Further Advancing Reform of Medical Devices Evaluation and Approval System | | 国家药监局综合司关于贯彻落实“证照分离”改革措施进一步推进医疗器械审评审批制度改革的通知 |
| (No. 43 [2018] of the Department of General Administration of the National Medical Products Administration) | | （药监综械注〔2018〕43号） |
| The food and drug administrations (medical products administration) of all provinces, autonomous regions and municipalities directly under the Central Government: | | 各省、自治区、直辖市食品药品监督管理局（药品监督管理局）： |
| As required by the Notice of the State Council on Promoting the Reform of “Separating Permits from Business Licenses” Nationwide (No. 35 [2018], State Council, hereinafter referred to as the “Notice”), for the purposes of further deepening the reform of “simplification of administrative procedures, decentralization of powers, combination of decentralization and regulation, and optimization of services” and the optimization of access services, comprehensively deepening the reform of the medical device evaluation and approval system, furthering innovation in medical device technology, promoting the high-quality development of medical devices, and meeting the clinical needs of the general public, the relevant matters are hereby notified as follows: | | 根据《国务院关于在全国推开“证照分离”改革的通知》（国发〔2018〕35号，以下简称《通知》）要求，为进一步深化“放管服”改革优化准入服务，全面深化医疗器械审评审批制度改革，促进医疗器械技术创新，推动医疗器械高质量发展，满足公众临床需求，现将有关事项通知如下： |
| I. General requirements | | 一、总体要求 |
| All drug regulatory authorities of all provinces, autonomous regions, and municipalities directly under the Central Government shall attach great importance, fully understand the significance of the reform of “separating permits from business licenses,” and conscientiously implement the specific reform issues as specified in the Notice. | | 各省、自治区、直辖市药品监督管理部门要高度重视，充分认识“证照分离”改革工作的重大意义，对照《通知》中明确的改革具体事项认真贯彻执行。 |
| As required by the Notice, by reference to the published regulations and documents related to medical devices, in light of the characteristics of local industry development and the evaluation and approval in real world, a work plan shall be developed, working measures shall be refined and implemented, and the work shall be advanced in strict accordance with the Notice and respective work plans. | | 要按照《通知》要求，参照已发布的医疗器械相关规章和文件，结合本地产业发展特点和审评审批实践情况，制定工作方案，细化落实工作措施，严格按照《通知》和各自的工作方案推进工作。 |
II. Implementing the specific measures for the reform of “separating permits from business licenses”
．．．．．． | | 二、贯彻落实“证照分离”改革的具体措施
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