关于发布海南博鳌乐城国际医疗旅游先行区医疗器械临床真实世界数据应用试点品种沟通交流程序(试行)的通告(2022年第16号)
2022-04-22 14:00
为有序推进海南博鳌乐城国际医疗旅游先行区医疗器械临床真实世界数据应用试点工作,促进海南博鳌乐城国际医疗旅游先行区更快更好发展,加强对医疗器械试点品种的早期介入和全程指导,进一步提高医疗器械试点品种沟通交流的质量和效率,国家药品监督管理局医疗器械技术审评中心会同海南省药品监督管理局联合制定《海南博鳌乐城国际医疗旅游先行区医疗器械临床真实世界数据应用试点品种沟通交流程序(试行)》,现予发布。
特此通告。
附件:海南博鳌乐城国际医疗旅游先行区医疗器械临床真实世界数据应用试点品种沟通交流程序(试行)(下载)
附表:海南博鳌乐城国际医疗旅游先行区医疗器械临床真实世界研究试点品种沟通交流申请、答复和审核记录单(下载)
医疗器械技术审评中心
2022年4月18日
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