2018年是改革开放40周年,也是海南建省和兴办经济特区30周年。2018年4月,习近平总书记考察海南经济特区,宣布中央批准海南省成为中国第12个自由贸易试验区(“自贸区”)。根据中共中央、国务院中发〔2018〕12号文《关于支持海南全面深化改革开放的指导意见》的部署,要推动海南在2020年取得自贸区建设的重要进展,2025年初步建立自由贸易港,并且要全面落实完善博鳌乐城国际医疗旅游先行区(“先行区”)政策,鼓励医疗新技术、新装备、新药品的研发应用,制定支持境外患者到先行区诊疗的便利化政策。
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by Huang Jianwen 

With multiple authoritative statements drawing wide attention, Hainan’s pharmaceutical and healthcare industry is seeking comprehensive development

The year of 2018 is a remarkable year in Hainan’s pharmaceutical and healthcare industry. The mission of medial development is noted conspicuously in President Xi Jinping’s remarks celebrating the 30th anniversary of the founding of the Hainan Province and the Hainan Special Economic Zone, and the “Guiding Opinions of the CPC Central Committee and the State Council on Supporting Hainan in Comprehensively Deepening Reform and Opening-up” (“Guiding Opinions”). Furthermore, the “Decision of the State Council on Suspending the Implementation of the Regulations on the Supervision and Administration of Medical Devicesin the Boao Lecheng International Medical Tourism Pilot Zone, Hainan Province” (“Decision”), issued on April 2, has officially handed over to the Hainan Provincial Government the approval power associated with medical institutions’ using unregistered medical devices that are urgently needed for clinical use.
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作者:黄建雯   金杜律师事务所 商务合规部

  • 多项中央动态引发关注, 海南医药健康产业盼全面发展

2018年对于海南医药健康产业而言是意义非凡的一年。中共中央总书记习近平在庆祝海南建省办经济特区30周年大会上的讲话,以及《中共中央、国务院关于支持海南全面深化改革开放的指导意见》(“《指导意见》”)都对海南医药健康产业发展予以重点关注。不仅如此, 4月2日出台的《国务院关于在海南博鳌乐城国际医疗旅游先行区暂停实施<医疗器械监督管理条例>有关规定的决定》(“《决定》”)将医疗机构临床急需且在我国尚未注册的进口医疗器械事项上的审批权正式下放海南省政府。习总书记的讲话和《指导意见》中透露的顶层战略,以及《决定》所给予的分量十足的法律变通,都昭示着中央推进海南医药健康产业发展的决心和海南医药健康产业的巨大潜力。
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