Risk Points and Regulatory Countermeasures for Software as a Medical Device in Chongqing
Objective To provide a reference for the regulatory of the software as a medical device(SaMD)in Chongqing.Methods A total of 66 medical device software manufacturers(including SaMD and software components)in Chongqing that have applied for and completed at least one software(including software components)product registration in the past four years(from 2020 to 2023)were selected as research objects.The Questionnaire survey method,literature search method,field visit method and special discussion method were conducted to analyzed the risk points of SaMD,and regulatory countermeasures were put forward.Results As of October 2023,there were 19 SaMD manufacturers and 23 SaMD products in Chongqing,and their main risks cover five aspects:network security risks,enterprise risks,system risks,hospital risks,and post-regulatory risks.The main risks of enterprise were concentrated in four parts:institutions and personnel(15％),document management(30％),design and development(25％)and production management(25％),and the other risks accounted for 5％.Conclusion It is recommended that regulatory authorities should strengthen technical supervision,carry out risk publicity,improve the legal system,and learn from foreign experience;the registrant should strengthen the system,report and reevaluate;the medical institutions should strengthen the reporting mechanism of adverse events,consciously use software medical devices as required,and actively accept the supervision of relevant departments;Social co-governance should be strengthened to actively respond to the National Medical Device Safety Publicity Week,and the competent authorities should strengthen science popularization publicity and strengthen the self-discipline guidance of the industry.
Chongqingsoftware as a medical devicerisk pointsdrug regulatory
万方数据
维普
