一周法规汇总（2023.04.08-2023.04.14）
4月11日市场监管总局发布2023年度重点立法任务，加强市场监管法治建设。其中，重点立法任务包括持续推进市场准入准营退出便利化，不断优化营商环境，切实提升平台经济常态化监管水平，严格落实“三品一特”安全责任，进一步强化市场监管领域安全保障制修订《药品、医疗器械、保健食品、特殊医学用途配方食品广告审查管理暂行办法》、《行业标准管理办法》、《药品经营和使用质量监督管理办法》和《医疗器械不良事件监测和再评价管理办法》等规章；积极推动《药品管理法实施条例》《中药品种保护条例》等行政法规的修订。
2023年度药械重点立法任务
市场监管总局部署2023年度重点立法任务
医疗器械标准及标准化
国家药监局关于废止YY/T 0708《医用电气设备 第1-4部分：安全通用要求 并列标准：可编程医用电气系统》等6项医疗器械行业标准的公告（2023年第37号）Announcement of the National Medical Products Administration on the Abolishment of YY/T 0708 Medical Electrical Equipment - Part 1-4: General Requirements for Safety - Collateral Standard: Programmable Electrical Medical Systems and Other Six Industry Standards for Medical Devices (No. 37 of 2023) 为进一步优化医疗器械标准体系，国家药品监督管理局决定废止YY/T 0708《医用电气设备 第1-4部分：安全通用要求 并列标准：可编程医用电气系统》等6项医疗器械行业标准，现予以公布（见附件）。In order to further optimize the standard system of medical devices, the National Medical Products Administration has decided to abolish YY/T 0708 Medical Electrical Equipment - Part 1-4: General Requirements for Safety - Collateral Standard: Programmable Electrical Medical Systems and other six industry standards for medical devices, and is hereby published (see Attachment).Attachment: List of Information on Abolishment of Industry Standards for Medical Devices
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| | 医用电气设备第1-4部分：安全通用要求并列标准：可编程医用电气系统Medical Electrical Equipment - Part 1-4: General Requirements for Safety - Collateral Standard: Programmable Electrical Medical Systems | Abolished from May 1, 2023 |
| | 医疗器械生物学评价风险管理过程中生物学评价的实施指南Biological Evaluation of Medical Devices - Guidance on the Conduct of Biological Evaluation within a Risk Management Process | Abolished from May 1, 2023 |
| | Medical Devices - Quality Management Systems - Requirements for Regulatory Purposes | Abolished from November 1, 2023 |
| | 医用电气设备呼吸气体监护仪的基本安全和主要性能专用要求Medical Electrical Equipment - Particular Requirements for Basic Safety and Main Performances of Respiratory Gas Monitors | Abolished from January 1, 2026 |
| | General Specification for Medical Oxygen Generator with Molecular Sieve | It shall be abolished as of the date of issuance of the announcement |
| | Medical Devices - Quality Management - Medical Device Nomenclature Data Structure | It shall be abolished as of the date of issuance of the announcement |
（原文链接：https://www.nmpa.gov.cn/xxgk/ggtg/qtggtg/20230410161251138.html?type=pc&m=）
医疗器械上市后监管
国家医疗器械不良事件监测年度报告（2022年）
检验检测相关
4月7日，市场监管总局发布《检验检测机构能力验证管理办法》，该办法自发布之日起施行，《实验室能力验证实施办法》（国家认证认可监督管理委员会2006年第9号公告）同时废止。
人工智能相关
