(一)政策出台背景

    2020年6月，中共中央、国务院印发《海南自由贸易港建设总体方案》指出，2025年前实行部分进口商品零关税政策。

    (二)重要意义

    药品、医疗器械“零关税”政策的出台，将有利于降低享惠主体诊疗成本，以高质量供给激发和释放消费潜能，有利于增强自贸港特色产业竞争新优势，加速推动乐城在医疗技术、装备、药品与国际先进水平同步发展，有利于支持乐城先行区建设成为世界一流的国际医疗旅游目的地和医疗科技创新平台。

    (三)主要内容

    2024年9月5日，经国务院同意，财政部、国家卫生健康委、海关总署、税务总局、国家药监局近日联合印发《关于海南自由贸易港药品、医疗器械“零关税”政策的通知》（财关税〔2024〕21号），明确在全岛封关运作前，对在海南博鳌乐城国际医疗旅游先行区内注册登记具有独立法人资格并经认定的医疗机构、医学教育高等院校、医药类科研院所，进口本通知规定的药品、医疗器械，并按规定使用的，可免征进口关税、进口环节增值税。

    (四)适用范围

    对在海南博鳌乐城国际医疗旅游先行区内注册登记具有独立法人资格并经认定的医疗机构、医学教育高等院校、医药类科研院所适用。

    (五)常见问题解答

    1.适用的“零关税”药品医疗器械有哪些范围?

    答：一是已在我国批准注册的进口药品、医疗器械；二是按国务院有关规定，尚未获得我国批准注册，但经海南省人民政府批准允许在先行区内进口使用的药品(不含疫苗)、医疗器械。

    2.使用“零关税”药品、医疗器械有什么限制规定?

    答：享惠主体的医疗机构凭本机构医师开具的处方(医嘱)，向在本机构现场就诊的患者销售免税药品、医疗器械。销售量应符合诊疗需要及处方管理有关规定。患者在医疗机构获得的免税药品、医疗器械属于个人使用的最终商品，不得再次销售，应在先行区内使用，不得带离、寄递出先行区。

    (I)Background

    In June 2020, the CPC Central Committee and the State Council issued the “Master Plan for the Construction of the Hainan Free Trade Port”, stating that a zero-tariff policy for certain imported goods will be implemented before 2025.

    (II)Significance

    The introduction of the “zero-tariff” policy for drugs and medical devices will help reduce patients’ expenses in diagnosis and treatment, stimulate consumption through the supply of high-quality goods and services, enhance the competitive edge of the FTP’s distinctive industries, accelerate the use of the world’s most advanced medical technology, equipment, and drugs within the Pilot Zone, and support Lecheng to develop into a world-class destination for international medical tourism and an innovation platform of medical technology.

    (III) Key Facts

    On September 5, 2024, with the approval of the State Council, the Ministry of Finance, the National Health Commission, the General Administration of Customs, the State Taxation Administration, and the National Medical Products Administration jointly issued the “Notice on the Zero-Tariff Policy for Hainan FTP-imported Drugs and Medical Devices” (MOF Tariff [2024] No. 21), clarifying that before the start of independent customs operations in Hainan FTP, medical institutions, medical universities, and drug research institutes with independent legal entities registered and recognized in Boao Lecheng International Medical Tourism Pilot Zone can be exempted from import tariffs and import value-added tax when they import drugs and medical devices stipulated in this notice and use them in accordance with regulations.

    (IV) Scope of Application

    It applies to medical institutions, medical universities, and drug research institutes with independent legal entities registered and recognized in Boao Lecheng International Medical Tourism Pilot Zone.

    (V)FAQs

    Q1.What are the scopes of the “zero-tariff” drugs and medical devices?

    A: First, imported drugs and medical devices that have been approved for registration in China; second, drugs (excluding vaccines) and medical devices that have not yet been approved for registration in China but have been approved by the Hainan. Provincial People’s Government for import and use in the Pilot Zone in accordance with relevant regulations of the State Council.

    Q2.What are the restrictions regarding the use of “zero-tariff” drugs and medical devices?

    A: Medical institutions that enjoy the policy can sell duty-free drugs and medical devices to on-site patients according to the prescriptions (medical orders) issued by their own physicians. The sales volume should conform to the needs of diagnosis and treatment and the relevant regulations for prescription management. The duty-free drugs and medical devices obtained by patients in medical institutions are final goods for personal use and cannot be resold. They should be used within the Pilot Zone and cannot be taken or mailed out of the pilot zone.