基层医疗器械智慧监管新模式探索

Exploring New Models of Smart Supervision of Medical Devices at Grassroots Level

近年来,随着营商环境的优化和医疗器械产业的飞速发展,成都高新区医疗器械流通行业表现出强劲的发展势头,市场主体年均复合增长率达10%,但与之相对的行业监管力量却未得到明显提升,传统的监管模式已不适应“大市场、大监管”的发展形势,如何通过信息化、网络化构建科学、高效、智慧的监管体系,是基层监管部门亟需解决的新命题。本文以成都高新区探索试行医疗器械流通环节智慧监管为例,浅析基层在探索监管科学、创新监管方式、提升监管效能方面取得的经验做法及监管成效。

In recent years,with the improvement in business environment and rapid development of medical device industry,medical device distribution in the Chengdu High-tech Zone has gained strong momentum.Relevant market entities achieved an annual compound growth rate of 10%,but supervision failed to catch up with the market development.The traditional supervisory pattern for medical devices has fallen behind the new trend of“comprehensive regulation over an all-rounded market”.Supervisory departments at the grassroots level face the challenge of establishing a scientific,efficient and smart supervision system using the information network.Taking the smart supervision system for medical devices of Chengdu High-tech Zone as an example,this article analyzes the experience and results achieved in exploring scientific,innovative and effective supervision models at the grassroots levels.