Hainan Free Trade Port: Boao Lecheng International Medical Tourism

Pilot Zone Regulations

(Adopted at the 20th Meeting of the Standing Committee of the Sixth People's Congress of Hainan Province on June 16, 2020)

Chapter 1: General Provisions

Article 1   To promote the development of the Boao Lecheng International Medical Tourism Pilot Zone in Hainan Free Trade Port (hereinafter referred to as the Pilot Zone), these regulations are formulated based on relevant laws and administrative regulations, combined with the actual conditions of our province.

Article 2    The pilot zone should align with the relevant requirements for building the Hainan Free Trade Port, benchmark against the highest international standards, and innovate its systems and mechanisms. It should take the lead in piloting initiatives across areas such as industrial policies, investment promotion, medical innovation, tourism services, and cross-border trade in services—leveraging high-level openness to drive the development of international medical tourism and cutting-edge healthcare services. Ultimately, the goal is to establish a world-class international medical tourism destination and a premier platform for medical technology innovation.

Article 3 The Provincial People's Government should strengthen organizational leadership over the construction of the pilot zone, decide on major issues related to its development, and establish a performance evaluation and assessment mechanism.

The provincial government's leading body for advancing the pilot zone development is responsible for providing guidance, oversight, promotion, and coordination of the initiative, as well as addressing key issues arising during the pilot zone's construction.

Relevant departments of the provincial people's government are responsible for providing specific guidance, coordination, and services related to the construction of the pilot zone, according to their respective responsibilities.

Article 4   Establish a management authority within the pilot zone. This authority is the legally designated body responsible for carrying out relevant administrative management and public service duties in the pilot zone. It will specifically oversee comprehensive coordination, development and construction, operational management, industrial growth, investment promotion, institutional innovation, and business support—while also exercising corresponding administrative approval and enforcement powers as authorized or delegated.

The management authority of the pilot zone, guided by the principles of streamlining and efficiency, independently determines organizational structure, job positions, personnel recruitment, and salary standards—all within the overall payroll budget—except for personnel appointed in accordance with relevant regulations.

Senior management and other staff of the pilot zone's administrative body can be recruited from overseas.

Article 5   The management authority of the pilot zone may, in accordance with the law, establish a development and operation company, entrusting it with the responsibility for investing in industries within the zone, as well as constructing and operating infrastructure and public service facilities, and participating in the organization and implementation of park management services.

Article 6   The People's Government of Qionghai City and its relevant departments are responsible for exercising the social management functions of the pilot zone, with the specific scope defined by the provincial People's Government.

The Qionghai Municipal People's Government and its relevant departments should support the development of the pilot zone in areas such as planning, investment promotion, infrastructure construction, institutional innovation, and policy implementation.

Article 7    The provincial and Qionghai Municipal People's Governments, along with their relevant departments, shall, in accordance with the law, delegate or entrust the management authority related to these matters to the administrative body of the pilot zone for exercise.

Management authorities that should not be delegated or entrusted for exercise may, as stipulated, allow relevant departments of the provincial and Qionghai Municipal People's Governments to establish resident agencies within the pilot zone.

Relevant departments of the provincial people's government, management institutions of the pilot zones, and resident agencies should clearly define their administrative authorities within the pilot zones, legally prepare lists of powers and responsibilities, and publicly announce them after approval.

Chapter 2: Development and Construction

Article 8   The management authority of the pilot zone is responsible for organizing the preparation of the pilot zone's detailed regulatory plan and industrial development plans, which will be implemented after approval.

Relevant planning for areas surrounding the pilot zone should align with the pilot zone's detailed regulatory plan as well as industrial development strategies.

Article 9    The pilot zone should rigorously implement the ecological and environmental protection system, as well as the ecological conservation redline management system. It must enforce strict resource conservation practices and high environmental entry standards, while enhancing ecological protection infrastructure and measures, and firmly pursuing green, low-carbon, and circular development.

Article 10    The pilot zone should strengthen the comprehensive planning and synchronized construction of infrastructure—including road networks, power grids, optical networks, gas networks, water networks, and supporting services for production and daily life—to foster integrated industry-city development.

The People's Government of Qionghai City and the management authority of the Pilot Zone should establish a coordination mechanism for development and construction, jointly planning and managing the infrastructure, public service facilities, and other supporting amenities in the Pilot Zone and its surrounding areas, thereby promoting integrated regional planning and collaborative growth.

Article 11   The provincial people's government should provide financial support to the pilot zone through various means, including bond funds, special funds, and subsidies.

Article 12    Land use in the pilot zone should align with the zone's comprehensive detailed planning and industrial development needs, while implementing a stringent system of land conservation and intensive use to enhance the efficiency of land utilization.

Article 13    The Provincial People's Government should coordinate and allocate annual new construction land plan indicators for the pilot zones, prioritizing the allocation to key industries and major projects.

In the pilot zones, flexible and diverse land supply methods can be adopted, including allocation, transfer, leasing, contribution of land value as capital investment, or equity participation. Rural collectively-owned construction land can also be utilized for industrial project development through methods such as transfer, leasing, contribution of land value as capital, or equity participation.

Article 14    Property assets—such as industrial buildings, office spaces, commercial facilities, apartments, and parking areas—constructed on land provided for a fee within the pilot zone, are managed by the pilot zone's administrative body. These properties are dedicated to supporting industries in the zone, funding public service infrastructure, and providing housing for talent.

Chapter 3: Industry Development

Article 15    Support is given to providing public hospital brands, trademarks, patents, technologies, services, and management—through franchising—to medical institutions in the pilot zone, while also encouraging public hospitals to establish a presence in the zone.

Article 16   Encourage domestic and foreign capital to invest in establishing medical institutions within the pilot zone, and ease restrictions on foreign capital ownership ratios. Privately-run medical institutions will enjoy equal treatment with public hospitals in areas such as access to medical services, designation for social insurance, professional title evaluation, hospital ranking assessments, research and teaching activities, and discipline development.

Support the introduction and development of medical institutions in the pilot zones, including internationally advanced health management organizations, medical tourism and wellness centers, and third-party medical testing facilities.

Article 17   Support the establishment of advanced clinical medicine research centers, clinical trial institutions, and key laboratories—along with other medical research facilities—in the pilot zone. Additionally, collaborate with world-renowned medical schools to set up new medical institutions. Encourage leading domestic and international research institutes, medical schools, national key laboratories, and prominent enterprises to establish branch offices within the pilot zone.

Support the introduction and development of international academic exchange platforms and global medical organizations in the pilot zones, and encourage the organization of international conferences and trade events in the healthcare sector.

Article 18   Support the establishment of a national pilot demonstration base for the transfer and commercialization of pharmaceutical research outcomes in the pilot zone, explore pilot initiatives to facilitate the transfer and application of achievements from China's major national science and technology projects focused on innovative drug development, and encourage the construction of industrialized production facilities, as well as platforms and trading centers dedicated to the transfer and commercialization of pharmaceutical technology advancements.

Article 19   Medical institutions in the pilot zone can conduct research and translate cutting-edge technologies such as stem cell therapy, immune cell therapy, monoclonal antibody drugs, gene therapy, and tissue engineering within the pilot zone.

Article 20   Encourage the initiation of clinical real-world data application research in pilot zones, exploring ways to leverage such data for drug and medical device product registration, thereby shortening time-to-market.

Article 21   The pilot zone can establish a regional formulation center to undertake or accept commissioned production of pharmaceutical preparations for medical institutions within the pilot zone.

Medical institution preparations can be dispensed and used in the pilot zones, with specific measures to be formulated by the provincial people's government's drug supervision and administration department.

Implement filing management for traditional Chinese medicine preparations commissioned by medical institutions and those prepared using traditional techniques.

The provincial people's government's drug supervision and administration department should strengthen management over the registration, preparation, and use of pharmaceutical preparations in the pilot zone's medical institutions, ensuring that these preparations are safe and effective.

Article 22   The tourism and culture authorities should collaborate with the management bodies of the pilot zones, health and wellness administration departments, and other relevant agencies to promote the integrated development of healthcare and tourism. Leveraging the province's rich tourism resources, they should guide the development of high-end health checkups, personalized wellness programs, medical services, traditional Chinese medicine-based health care, and specialized wellness retreats. Additionally, they should strengthen efforts in developing innovative medical and health products, as well as designing tailored tourism itineraries, while expanding into extended medical tourism initiatives such as medical-care integration, leisure-based wellness experiences, and health-focused agricultural tourism.

Encourage domestic and international travel agencies and other organizations to provide specialized medical tourism brokerage services for the pilot zone, intensify efforts to promote and market medical tourism, and offer end-to-end medical tourism solutions.

Article 23   The pilot zone should promote the inheritance and cultural dissemination of traditional Chinese medicine, advance TCM research and innovation, and foster international cooperation as well as the growth of TCM-related service trade.

Article 24 Clinical urgently needed imported medicines (excluding vaccines) and medical devices intended for use in the pilot zone can be stored in bulk at the zone's bonded warehouse before approval, allowing for single entry with multiple customs clearances—ensuring that once approved, they can be immediately retrieved and put into use.

Medical institutions in the pilot zone are permitted, upon filing and commitment, to take eligible imported medicines out of the zone for use, in accordance with the relevant regulations of this province.

The pilot zone is permitted to expand the range of imported health foods and healthcare devices from overseas. Under compliance with relevant regulations, the zone may also import special medical foods that are already available in foreign markets but not yet approved for sale domestically.

Article 25   Foreign medical staff, patients, and accompanying personnel visiting the pilot zone for medical treatment can enjoy streamlined entry, exit, stay, and residency policies and measures offered by the Hainan Free Trade Port.

Article 26   The pilot zone will establish a collaborative mechanism between insurance institutions and medical facilities within the zone, encouraging the development of diversified, specialized, and personalized commercial health insurance products. It will also streamline claims processes and explore ways to integrate these offerings with international commercial insurance payment systems.

Support financial institutions in the insurance industry to collaborate with overseas entities in the pilot zone to develop cross-border commercial health insurance products.

Article 27 In the pilot zone, a system of liberalized and facilitated cross-border capital flows will be implemented in accordance with relevant regulations of the Hainan Free Trade Port. Restrictions on foreign direct investment, cross-border financing, and personal cross-border transactions will be eased, while procedures such as foreign exchange registration, external debt registration, and mechanisms for capital inflows, outflows, and foreign exchange settlement/purchase will be streamlined.

Article 28 Enterprises and individuals in the pilot zone enjoy preferential tax policies—such as exemptions from tariffs, corporate income tax, and personal income tax—under the relevant provisions of Hainan Free Trade Port's tax system.

Article 29    Physicians practicing (including those from overseas) whose primary practice institution is located in the Pilot Zone can directly practice at other medical institutions within the same zone.

Nurses (including those from overseas) can practice at multiple locations within the pilot zone.

Article 30   The pilot zone should attract high-level and urgently needed talent from both domestic and international sources. It can independently identify high-caliber professionals within the zone and, for critically needed talent, may flexibly adjust requirements such as educational qualifications, age, and professional titles based on actual needs.

Relevant administrative departments should optimize talent support mechanisms, providing convenience in areas such as talent visas, visa extensions and residency permits, talent immigration, housing, healthcare, employment, project and award applications, and education.

The pilot zone independently conducts the evaluation of senior professional and technical titles in the health sector, in accordance with relevant national and provincial regulations.

Professional and managerial talents in healthcare, tourism, and other specialized fields from state-owned enterprises and public institutions can take on part-time positions with concurrent pay in the pilot zone, as per regulations.

Chapter 4: Service Management

Article 31   Implement and deepen the ultra-simplified approval reform in the pilot zones, encouraging management authorities in these zones to explore innovative approaches and experiment with new management models tailored to their specific needs.

The management authority of the pilot zone should streamline approval processes, shorten processing timelines, and enhance the efficiency of administrative approval services within its jurisdiction.

The management authority of the pilot zone should establish a mechanism to ensure the successful implementation of investment projects, implement a full-process tracking and service accountability system, and provide high-quality, convenient services such as comprehensive agency assistance for major investment projects. Additionally, they should promptly coordinate and resolve any issues arising during project approval, construction commencement, and ongoing operations.

Article 32    The provincial people's government's health and wellness administration department shall collaborate with the pilot zone management authority to formulate standards for establishing medical institutions in the pilot zone, along with implementation guidelines.

The management authority of the pilot zone, together with departments such as the Provincial People's Government’s Health Administration and Drug Supervision, conducts industry compliance reviews and assesses the advanced nature of medical technologies for the projects entering the zone, each according to their respective responsibilities.

The management authority of the pilot zone should establish an exit mechanism for underperforming market entities within the zone, ensuring the healthy development of the medical tourism industry.

Article 33 For medical institutions established in the pilot zones, the "Approval Certificate for Establishing Medical Institutions" will no longer be issued—only the "Medical Institution Practice License" will be granted.

Applications for setting up medical institutions in the pilot zone and for equipping Class A large-scale medical devices can be reviewed and approved together.

Article 34   The pilot zone should improve its medical ethics review system and strengthen ethical oversight of clinical research and applications.

The provincial government's health and drug administration departments' district-level institutions should strengthen supervision over medical institutions and professionals in the pilot zone to ensure compliance with medical ethical standards.

Article 35    The intellectual property management department of the provincial people's government should collaborate with the pilot zone management authority and other relevant departments to strengthen intellectual property protection in the medical and healthcare sector within the pilot zone. They should also improve diversified mechanisms for resolving IP disputes and providing rights-protection assistance, as well as enhance cooperation on foreign-related IP enforcement. Additionally, medical institutions are encouraged to actively pursue international patent applications and register international trademarks.

Article 36    Medical institutions in the pilot zone should establish a responsibility system for medical waste management and ensure full implementation of responsibilities for managing medical waste.

The provincial government's health and drug administration departments' district-level offices, along with the Qionghai Municipal Government's ecological environment management department, will implement supervision and management of medical waste management in the pilot zone according to their respective responsibilities.

Article 37    The provincial government's health and drug administration departments stationed in the district should strengthen supervision and inspection of pharmaceuticals and medical devices in the pilot zone, promptly investigate and address any illegal activities, and ensure the quality and safety of medicines and medical devices.

The pilot zone has established a traceability management platform for pharmaceuticals and medical devices, enabling end-to-end tracking of the entire process—from import and approval to usage and regulation. This system facilitates networked data sharing among health and wellness authorities, drug regulatory departments, customs, and all medical institutions within the pilot zone.

Article 38    The provincial government's health and drug administration departments stationed in the district shall implement comprehensive oversight of medical institutions operating in the pilot zone, healthcare professionals, clinical application of medical technologies, the order of the healthcare services industry, and the medical and healthcare industry as a whole, ensuring both medical quality and patient safety.

The provincial government's health and pharmaceutical regulatory departments' district-level institutions should strengthen oversight of business collaborations among medical institutions in the pilot zone, and establish a filing and management system for external partnerships involving these institutions.

Article 39    The management authority of the pilot zone shall collaborate with relevant departments of the provincial and Qionghai municipal governments to establish credit records for medical institutions and their practitioners, in accordance with national regulations. It will also ensure the timely public disclosure, transparency, and sharing of credit information related to these entities and individuals, implementing joint incentives for trustworthiness and joint penalties for untrustworthiness.

Encourage medical industry associations to conduct evaluations of medical institutions in the pilot zones, focusing on aspects such as healthcare quality and service capabilities.

Article 40   The provincial People's Government departments responsible for health management, drug supervision, and other related areas should collaborate with the management authorities of the pilot zone to establish an early-warning system focused on preventing medical risks. They should also strengthen emergency response plans and mechanisms for handling sudden incidents, while supervising and guiding medical institutions to enhance their medical risk management practices and refine measures for identifying, assessing, and mitigating potential risks—ensuring comprehensive protection against all types of threats.

Chapter 5: Legal Liability

Article 41   If the management authorities of the pilot zone, relevant departments of the provincial and Qionghai municipal governments, and their staff engage in acts such as abusing power, neglecting their duties, or engaging in corruption and malpractice while performing service and management tasks in the pilot zone, the directly responsible officials and other individuals bearing direct accountability will be disciplined according to law. If such actions constitute a crime, criminal liability will be pursued without exception.

Article 42   The pilot zone has established an innovative tolerance mechanism, under which those involved in any of the following situations may receive lighter or reduced penalties—or even be exempt from liability—according to relevant national and provincial regulations:

In the process of advancing reform and innovation in the pilot zone, mistakes occurred due to a lack of experience and the experimental nature of being first to try.

Mistakes in exploratory trials where no clear limitations have yet been established;

For unintentional mistakes made in the pursuit of reform and development;

Other circumstances prescribed by laws and regulations where liability may be mitigated, reduced, or exempted.

Chapter 6: Supplementary Provisions

Article 43: This regulation shall come into effect as of the date of its promulgation.