Meng Yun, Dong Qian, Rong Shankui, Shao Shushu, Xu Huiwen
National Institutes for Food and Drug Control(Center for Medical Device Standardization Administration, NMPA), Beijing, 102629.
Zhongguo Yi Liao Qi Xie Za Zhi. 2023 Jul 30;47(4):433-436. doi: 10.3969/j.issn.1671-7104.2023.04.015.
Standard drafting is an important part in the process of standard formulation and revision. By analyzing the status of the medical device industry standards drafting, thoughts and suggestions were proposed to further promote all relevant parties to actively participate in the standard drafting, effectively improve the quality of the standards, strengthen the technical support and promote the high-quality development of the industry. The statistical data of the participation of social organizations in the drafting and as the first unit drafting medical devices standards from 2017 to 2021 was researched, and the problems in the drafting of standards at this stage were analyzed. Based on the research and analyses, some thoughts and suggestions were proposed to strengthen the management of standard drafting units and promote the participation of all relevant parties in standard drafting. It is necessary to expand and enhance social participation in standard drafting further by innovating incentives, refining and strengthening normative requirements, and creating a positive social atmosphere.
标准起草是标准制定和修订过程中的重要环节。通过分析医疗器械行业标准起草的现状，提出了思路和建议，以进一步推动各方积极参与标准起草，有效提高标准质量，加强技术支撑，促进产业高质量发展。研究了2017年至2021年社会组织参与医疗器械标准起草及作为第一起草单位的统计数据，并分析了现阶段标准起草中存在的问题。基于研究与分析，提出了加强标准起草单位管理、推动各方参与标准起草的一些思路和建议。有必要通过创新激励机制、细化和强化规范性要求、营造积极的社会氛围，进一步扩大和增强社会对标准起草的参与度。
