基于政策工具的安徽省医疗器械政策文本分析OACSTPCD

Objective:To sort out medical device related policies in Anhui Province,to analyze the distribution of content in each policy text to provide reference for policy optimization in the later stage.Methods:The official websites of the People's Government of Anhui Province and the Anhui Provincial Drug Administration were searched by using the keywords of"medical devices","medical device enterprises",and"medical consumables"to search for medical device related policy documents released from January 2011 to December 2022.The 21 medical device-related policy documents retrieved shall be coded using the content analysis method in the sequence of"policy code-chapter number-unit number-sentence number".A two-dimensional analytical framework of"Basic Policy Instruments-Involved Subjects"was constructed to quantitatively analyze the medical device policy text from the two dimensions of policy instruments-involved subjects.Results:A total of 338 items were codes,including 107 supply-based policy tools(accounting for 31.66%),40 demand-based policy tools(accounting for 11.83%),and 191 environmental policy tools(accounting for 56.51%).The 338 codes involved entities including 202 government departments(accounting for 59.76%),62 operating enterprises(accounting for 18.34%),59 production enterprises(accounting for 17.46%),9 medical institutions(accounting for 2.66%),and 6 industry associations(accounting for 1.78%).Conclusion:The medical device policy in Anhui Province is mainly based on environmental policy tools,and demand-based policy tools are rarely used.The rationality of the distribution of internal items and participating entities in policy tools needs to be improved.There are certain differences in the interaction between each entity and policy tools.Therefore,it is necessary to strengthen the balance of policy tool use,increase the participation of multiple entities,and optimize the synergy between entities and policy tools.