医疗器械检验报告电子化改革研究

Research on the Electronic Reform of Medical Device Registration Reports

注册检验报告作为医疗器械注册审评审批的主要材料,如能实现注册检验报告电子化,将有助于提升医疗器械产品注册审评审批效率。广东省药品监督管理局已推行医疗器械首次注册用检验报告电子化改革。文章通过对首次注册用报告电子化改革的研究,分析报告电子化推送存在的问题,改善报告电子化推送模式。尝试推动检验报告电子化在其他方面的运用,通过信息化手段,实现注册检验报告全类型推送,电子检验报告真伪查询,政府部门检验报告共享等优化便民举措。

As the main material for the review and approval of medical device registration,the electronic registration inspection report will help improve the efficiency of medical device product registration review and approval.The Guangdong Provincial Drug Administration has implemented the electronic reform of inspection reports for the first registration of medical devices.Through research on the electronic reform of reports for the first registration,this article analyzes the problems in the electronic push of reports and improves the electronic push mode of reports.Attempt to promote the application of electronic inspection reports in other areas,and through information technology,optimize and facilitate measures such as promoting all types of registered inspection reports,querying the authenticity of electronic inspection reports,and sharing inspection reports among government departments.