本课题紧紧围绕医疗器械流通市场的现状及变化趋势,试图对现有的监管方式和监管手段作出相应的调整,体现创新、发展、与时俱进的监管理念,是一项应用性课题研究。目的是,解决医疗器械经营企业“虚设仓库”、“地下仓库”和“仓库散、小、乱”的问题,引导其变“暗”为明,变“散乱”为集中,进一步完善医疗器械经营许可政策,提高监管的针对性和有效性。总体思路是,充分借鉴药品第三方物流的监管经验,在调研的基础上,论证制定医疗器械第三方物流监管政策的必要性与可行性,并提出相应的工作方案。
<<In this applied research project,the authors focused on current status and developing trend of the medical device market,trying to modify the existing control methods and monitoring tools to make corresponding adjustments to reflect the innovation,development,and advancing with the regulatory philosophy. The purpose is to resolve the management problems of medical device warehouse,including “dummy warehouse,” “underground storage” and “warehouses scattered,small and chaos”,to change “illegal” as “legal” and “scattered” as the “centralized”,and to further improve the policy of medical device warehouse to enhance the relevance and effectiveness of supervision. The general idea is to fully draw on third-party logistics supervision of pharmaceutical experience to investigate the need of medical devices for third-party logistics and feasibility of regulatory policies,and to propose the corresponding policy.
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