新《标准化法》语境下卫生健康强制性标准的思考

摘要：

2017年，我国《标准化法》实施30年后进行了首次重大修订，此次修订摒弃了原《标准化法》中诸多带有计划经济彩色的标准管理措施，建立了许多体现市场经济和现代国家治理要求的标准化管理制度。针对强制性标准进行的制度调整是此次修法的重要内容，这既是对近年来我国强制性标准改革成果的固化，也是对未来我国强制性标准发展的制度谋划。本文拟针对新《标准化法》关于强制性标准的制度调整，分析对卫生健康强制性标准工作带来的影响和挑战，同时提出相应对策建议。

Abstract:

In 2017, the Standardization Law of China was significantly revised for the first time 30 years after its implementation. This revision abandoned many standard management measures with the characteristics of planned economy and established many standardized management systems reflecting the requirements of market economy and modern national governance. The institutional adjustment of mandatory standards is an important part of this revision, which is not only the solidification of the achievements of China’s mandatory standards reform in recent years, but also the institutional planning for the development of China’s mandatory standards in the future. Aimed at the institutional adjustment of mandatory standards in the revised Standardization Law of China, this paper analyzes the impact and challenges on the mandatory standards for health, and puts forward relevant strategies and suggestions.

基金项目：本文系国家卫生健康委法规司年度重点课题“强制性国家标准实施情况统计分析制度研究”阶段性成果。

作者简介：程雪莲，西南政法大学博士研究生，研究方向为民商法学、医事法学。