日前，海南省药品监督管理局、海南省卫生健康委员会、海口海关联合印发关于《进一步优化监管服务支持海南博鳌乐城国际医疗旅游先行区高质量发展若干措施》的通知（以下简称《若干措施》，全文附后）。《若干措施》意在进一步优化海南博鳌乐城国际医疗旅游先行区营商环境，简化临床急需进口药品医疗器械审批流程，优化审批模式，提升监管服务效能，便利公众及时使用临床急需进口药品医疗器械，助力乐城先行区高质量发展。

Recently, Hainan Provincial Drug Administration, Hainan Provincial Health Commission and Haikou Customs jointly issued a notice on the "Several Measures to Further Optimization of Regulatory Services to Support the High-Quality Development of Hainan Boao Lecheng Pilot Zone of International Medical Tourism" (hereinafter referred to as "Several Measures", the full text is attached). "Several Measures" is intended to further optimize the business environment in Hainan Boao Lecheng pilot zone of international medical tourism, simplify the approval process of imported drugs and medical devices in urgent clinical need, optimize the approval mode, improve the effectiveness of regulatory services, facilitate the public to timely use imported drugs and medical devices in urgent clinical need, and help the high-quality development of Lecheng pilot zone.

文件原文如下

The document reads as follows

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为进一步优化海南博鳌乐城国际医疗旅游先行区营商环境，简化临床急需进口药品医疗器械审批流程，优化审批模式，提升监管服务效能，便利公众及时使用临床急需进口药品医疗器械，助力乐城先行区高质量发展。经研究，制定如下措施：

To further optimize the business environment in Hainan Boao Lecheng pilot zone of international medical tourism, simplify the approval process of imported drugs and medical devices in urgent clinical need, optimize the approval mode, improve the effectiveness of regulatory services, facilitate the public to timely use imported drugs and medical devices in urgent clinical need, and help the high-quality development of Lecheng pilot zone, after research, the following measures are developed:

一、海南省卫生健康行政管理部门负责对申请使用临床急需进口药品医疗器械的医疗机构进行资格评估审核，支持医疗机构根据自身科室能力情况分科室申请评估。拟从事使用临床急需进口药品医疗器械业务的医疗机构，应当向海南省卫生健康行政管理部门提出申请，并具备以下条件：

I. The health administration department of Hainan Province is responsible for the qualification assessment and review of medical institutions that apply for the use of imported drugs and medical devices in urgent clinical need, and support medical institutions to apply for assessment in accordance with their own departmental capacity by department. Medical institutions that intend to engage in the business of using imported drugs and medical devices in urgent clinical need should apply to the health administration department of Hainan Province, and have the following conditions:

（一）依法取得医疗机构执业许可，具备与所申请临床急需进口药品医疗器械相适应的专业科室（含远程诊疗医疗团队）；

(I). Obtain a license to practice as medical institution in accordance with the law, with a professional department (including telemedicine medical team) appropriate to the imported drugs and medical devices in urgent clinical need applied for;

（二）具有符合临床急需进口药品医疗器械特性和说明书要求的，在其流通、运输、储存及保管方面的保障条件和管理制度；

(II). Has developed guarantee conditions and management systems in their circulation, transportation, storage and custody if it meets the requirements of characteristics and instructions of the imported drugs and medical devices in urgent clinical need;

（三）设置药品医疗器械不良反应监测机构，配备专职人员并已接受专业培训，能够正确履行不良反应监测职责；

(III). Set up drug and medical device adverse reaction monitoring institutions, equipped with full-time personnel who have received professional training, to be able to properly perform the monitoring of adverse reactions;

（四）具有使用临床急需进口药品医疗器械可能发生严重不良反应的应急预案和处置能力。

(IV). If serious adverse reactions may occur due to the use of imported drugs and medical devices in urgent clinical need, the ability to develop emergency plans and disposal.

海南省卫生健康行政管理部门受理申请后，应当在十个工作日内作出是否准予医疗机构相关科室使用临床急需进口药品医疗器械业务的决定。获得使用临床急需进口药品医疗器械资格的医疗机构称为指定医疗机构。

After receiving the application, the health administration department of Hainan Province shall make a decision within ten working days whether to allow the relevant departments of medical institutions to use the imported drugs and medical devices in urgent clinical need. Medical institutions qualified to use imported drugs and medical devices in urgent clinical need are called designated medical institutions.

二、指定医疗机构根据目标适应症，提出申请使用临床急需进口药品医疗器械的品种、数量，按照申报要求，在特许药械追溯管理平台线上递交申请，并承诺申请资料合法、真实、准确、可溯源，临床急需进口药品医疗器械在本医疗机构使用。申报指南另行制定。

II. Designated medical institutions should, according to the target indications, specify the type and quantity of imported drugs and medical devices in urgent clinical need to be applied for use, submit applications online in the licensed drugs and devices traceability management platform in accordance with the declaration requirements, and undertake that the application information is legal, true, accurate and traceable, and that the imported drugs and medical devices in urgent clinical need are used in this medical institution. Declaration guidelines are developed separately.

三、海南省卫生健康行政管理部门、药品监督管理部门依职责对指定医疗机构申请使用的临床急需进口药品医疗器械进行评估审核。

III. The health administration department and drug administration of Hainan Province shall, in accordance with their duties, evaluate and review the imported drugs and medical devices in urgent clinical need that are applied for use by designated medical institutions.

在受理指定医疗机构提出使用临床急需进口药品医疗器械的申请后，海南省卫生健康行政管理部门应当在三个工作日内完成审核，海南省药品监督管理部门应当在七个工作日内作出是否准予进口的行政决定。

After receiving the application from designated medical institutions to use the imported drugs and medical devices in urgent clinical need, the health administration department of Hainan Province shall complete the review within three working days, and the drug administration of Hainan Province shall make an administrative decision within seven working days whether to grant the import.

临床急需进口药品医疗器械在乐城先行区首次获批使用后，后续申请均视为非首次，审批由乐城医药监管部门负责实施。

After the imported drugs and medical devices in urgent clinical need is approved for the first time for use in the Lecheng pilot zone, all subsequent applications are considered non-first time, and the approval is implemented by the Lecheng Pharmaceutical Regulatory Department.

四、对于境内外管理属性不一致的临床急需进口药品医疗器械，按境外批准的属性管理。

IV. For imported drugs and medical devices in urgent clinical need with inconsistent management properties inside and outside the country, it is managed according to the properties approved outside the country.

五、指定医疗机构应当委托药品或者医疗器械经营企业采购、进口和配送临床急需进口药品医疗器械。

V. Designated medical institutions should entrust pharmaceutical or medical device enterprises to purchase, import and distribute the imported drugs and medical devices in urgent clinical need.

受委托药品或者医疗器械经营企业（以下简称“受委托经营企业”）应当持有《药品经营许可证》或者《医疗器械经营许可证》。

Entrusted pharmaceutical or medical device enterprises (hereinafter referred to as "Entrusted Enterprises") shall hold a "drug business license" or "medical device business license".

六、海南省药品监督管理部门和海口海关按规定对临床急需进口药品医疗器械办理通关手续，支持临床急需进口药品医疗器械电子化通关。指定医疗机构及受委托经营企业不得进口翻新医疗器械或者从国外医疗机构转让在用医疗器械。禁止进口过期、失效、淘汰和已使用过的医疗器械。

VI. Hainan Provincial Drug Administration and Haikou Customs shall handle clearance procedures for imported drugs and medical devices in urgent clinical need in accordance with the provisions and support electronic customs clearance of imported drugs and medical devices in urgent clinical need. Designated medical institutions and entrusted enterprises shall not import refurbished medical devices or transfer medical devices in use from foreign medical institutions. It is forbidden to import expired, invalid, obsolete and used medical devices.

临床急需进口药品无需进口检验。医疗器械和列入《特殊物品海关商品编号和检验检疫名称对应表》的物品，按照海关相关规定办理行政许可。

Imported drugs in urgent clinical need are not subject to import inspection. Medical devices and items included in the "Correspondence Table of Customs Commodity Codes and Inspection and Quarantine Names for Special Items" shall be subject to administrative licensing in accordance with relevant customs regulations.

七、获批使用的临床急需进口药品医疗器械视同已在乐城先行区批准进口注册的品种，允许接受慈善捐赠，且按临床急需进口药品医疗器械进行管理。

VII. The imported drugs and medical devices in urgent clinical need approved for use is treated as a variety that has been approved for import registration in Lecheng pilot zone and is allowed to receive charitable donations and is managed according to the imported drugs and medical devices in urgent clinical need.

八、指定医疗机构根据患者病情及安全情况，确认患者将临床急需进口药品医疗器械带离乐城先行区使用的必要性，制定带离方案及应急预案，在特许药械追溯管理平台上备案后，患者可将仅供自用、合理量的临床急需进口药品医疗器械带离乐城先行区使用。临床急需进口药品医疗器械带离乐城先行区使用管理办法由海南省药品监督管理部门另行制定。

VIII. Designated medical institutions shall, according to the patient's condition and safety, confirm the necessity of the patient to take imported drugs and medical devices in urgent clinical need out of Lecheng pilot zone for use, develop a take-away plan and an emergency plan. And after filing on the licensed drugs and devices traceability management platform, the patient may take a reasonable amount of imported drugs and medical devices in urgent clinical need out of Lecheng pilot zone only for his own use. The management method of taking imported drugs and medical devices in urgent clinical need out of Lecheng pilot zone for use shall be separately developed by Hainan Provincial Drug Administration.

九、海南省药品监督管理部门会同乐城先行区管理部门建立特许药械追溯管理平台，实现临床急需进口药品医疗器械的申请、采购、进口、配送、使用和不良反应监测等全过程追溯管理。

IX. Hainan Provincial Drug Administration in conjunction with the Lecheng pilot zone management department to establish a licensed drugs and devices traceability management platform to achieve the application, procurement, import, distribution, use, adverse reaction monitoring and other whole-process traceability management of the imported drugs and medical devices in urgent clinical need.

指定医疗机构、受委托经营企业、乐城先行区保税仓应使用特许药械追溯管理平台对临床急需进口药品医疗器械进行管理，落实产品全程可追溯主体责任。

Designated medical institutions, entrusted enterprises and Lecheng pilot zone bonded warehouses should use the licensed drugs and devices traceability management platform for the management of imported drugs and medical devices in urgent clinical need, and the implementation of the main responsibility of whole-proces traceability of the product.

十、指定医疗机构不再具备使用临床急需进口药品医疗器械的能力和条件的，海南省卫生健康行政管理部门对其相关科室使用临床急需进口药品医疗器械资格予以取消。

X. For designated medical institutions no longer have the ability and conditions to use imported drugs and medical devices in urgent clinical need, the health administration department and drug administration of Hainan Province shall disqualify its relevant departments to use imported drugs and medical devices in urgent clinical need.

十一、指定医疗机构应当开展临床急需进口药品医疗器械使用安全性和有效性评价，每年向海南省卫生健康行政管理部门和药品监督管理部门报告上一年度临床急需进口药品医疗器械使用情况的评估报告。

XI. Designated medical institutions shall carry out the safety and effectiveness evaluation of the use of imported drugs and medical devices in urgent clinical need, and report annually to the health administration department and drug administration of Hainan Province on the evaluation report of the use of imported drugs and medical devices in urgent clinical need in the previous year.

十二、临床急需进口药品医疗器械在国内获批上市后，如存在未获批适应症的，该产品可作为临床急需进口药品医疗器械申请使用，仅限用于未获批适应症。

XII. After the imported drugs and medical devices in urgent clinical need is approved for marketing in China, if there are unapproved indications, the product can be applied for use as imported drugs and medical devices in urgent clinical need only for unapproved indications.

十三、鼓励指定医疗机构引入保险机制，购买医疗商业保险。使用临床急需进口药品医疗器械造成患者人体伤害的，指定医疗机构按照国家有关规定承担责任。如由于产品原因造成伤害的，由指定医疗机构先行赔偿，再根据法定或约定向相关责任单位追偿。

XIII. Designated medical institutions are encouraged to introduce insurance mechanisms and purchase medical commercial insurance. If the use of imported drugs and medical devices in urgent clinical need causes human injury to the patient, the designated medical institution shall assume the responsibility in accordance with the relevant state regulations. If the injury is caused by the product, the designated medical institution pay compensation, and then recover from the relevant responsible unit according to the law or agreement.