Hainan Boao Lecheng International Medical Tourism Pilot Zone
Hainan Boao Lecheng International Medical Tourism Pilot Zone (HBL) is China’s only designated national medical zone that has been granted preferential policies and incentives to create a world-class international medical destination and cluster for advanced medical diagnosis, treatment, rehabilitation, medical R&D, and technological innovation in China.
HBL offers a special fast-track approval procedure that makes it easier and quicker for the HBL hospitals to introduce, test, procure, register, import, and use innovative medtech, healthtech, drugs, and rehabilitation equipment in need without an NMPA approval. But the approval does not apply to the rest of mainland China.
Main Criteria: 1) Product cannot have been approved in mainland China but needs CE/FDA/ICH member approval, 2) Product shall be "innovative" and cannot be replaced by an already approved predicate in China, and 3) Sales agreement for medical product to be signed first with HBL hospital applying for its specific use.​
* Please note that the fast-track approval process can only begin when a sales/ purchase agreement has been signed with one of the hospitals, but the approval will apply to all the hospitals at HBL.
​As of January 2026, 353 medical devices and 187 drugs have been approved by Hainan MPA for exclusive use at HBL. In addition, another 10 Health Foods (dietary supplements) and 3 Food for Special Medical Purposes have also been approved.
Moreover, it is the first place in China where it is possible to conduct Real-World Data (RWD) Studies of the use of medical devices and drugs imported under the fast-track approval procedure that can supplement the application for the NMPA registration which can accelerate the approval process to sell in all of China.
​As of January 2026, 47 licensed medical products have been included in the RWD Program in which 16 medical devices and 6 drugs have so far obtained an NMPA approval by using RWD studies at HBL.
CURRENT STATUS
When fully developed by 2035, Hainan Boao Lecheng is planned to cover 21 km2 with a total of 3 km2 of constructed land including infrastructure and buildings. Total construction costs are estimated at RMB 100 billion (USD 16 billion).
Today, 30 private hospitals, 3 public general hospitals, and 6 medical service centers have officially opened with another 10-15 planned and several underway.
When completed by 2035, it will provide 12,000 hospital beds, employ 28,500 medical personnel including 3,500 R&D staff.
In 2025, HBL received a total of 865,460 medical tourists compared to 413,700 in 2024 equal to a year-on-year increase of +109.2%.
LOCATION - GETTING THERE​
OTHER PREFERENTIAL POLICIES
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Approved medical devices and drugs at HBL can be promoted (not sold) all over mainland China.
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Foreign medical devices and drugs are exempted from import duties and import VAT and can be stored at HBL bonded warehouse before final approval.
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Oral, topical, and subcutaneous injections of drugs and medical devices can be taken home by patients for up to 12 weeks at the time.
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Products that have undergone a Real-World Study at HBL can be included in the national healthcare insurance reimbursement list.
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Overseas approved Health Foods (dietary supplements) and Food for Special Medical Purposes can be introduced and used at HBL without mainland China approval.
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HBL allows foreign doctors and nurses to practice at the hospitals for three years.
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Qualified medical institutions and FIEs at HBL can engage in the development and application of human stem cells, gene diagnostics, and therapy technologies for product registration and manufacturing.
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HBL allows the set-up of wholly foreign-owned and JV medical institutions/hospitals.