One place in China can legally use drugs and devices approved overseas but not yet approved here. This is how it works, which hospitals are inside, and what changed in 2026.
The Boao Lecheng International Medical Tourism Pilot Zone is a small area of Qionghai, on Hainan island, established by the State Council in 2013 and given powers no other part of China has. It is the country's only medical special zone, and it exists for a specific reason: to let patients in China reach medicines and technologies that are already approved elsewhere but not yet registered here.
Lecheng operates under what is described as four "special permissions" — the basis for everything else in the zone.
Approved hospitals may use imported drugs and devices that are already on the market overseas but not yet approved by China's regulator — the "special drug and device" policy.
Clinical research and real-world data work conducted inside the zone, including a national pilot for turning real-world clinical data into evidence for registration.
More flexible rules on investment, ownership and operation of medical institutions inside the zone.
International medical exchange and medical-tourism activity, including a visa pathway for patients travelling to the zone for treatment.
The zone's stated goal is to keep medical technology, equipment and drugs "in step" with international practice. Here is where that stands.
Figures reported by the zone authority and Hainan provincial government, 2025–2026. They change regularly — confirm current status for any specific drug or device before you travel.
Roughly 40 institutions operate in Lecheng, from branch campuses of China's leading public hospitals to specialist and international centres. These are the three we have verified and listed.
In May 2026 the zone named its first twelve "international medical tourism receiving institutions", including Ruijin Hainan, West China Lecheng, Boao Super Hospital, Shulan (Boao) Hospital, Boao Everlife, and specialist centres in ophthalmology, oncology and health management.
Lecheng is not a general "better hospitals" destination. Its value is narrow and specific.
If the standard option for your condition is a medicine approved in the US, EU or Japan but not yet registered in China, the zone is the one legal route to it inside the country.
The zone imports oncology drugs and offers some cellular-therapy programmes under a research framework. This is a genuinely different option from what is available on the mainland.
For conditions with few approved treatments anywhere, the zone's import pathway and international partnerships are a reason it exists.
A review inside the zone weighs not only surgery and standard therapy, but whether an unregistered drug or a research programme could apply to your case.
Two national regulations took effect in May 2026: the Regulations on the Administration of Clinical Research and Clinical Translation of New Biomedical Technologies (effective 1 May 2026) and the revised Implementation Regulations of the Drug Administration Law (effective 15 May 2026). Together they create two tracks — a technology track for new biomedical techniques and a drug track for registration — and for the first time set out how projects are stopped, not just approved.
In September 2026 the zone published draft rules on suspending and withdrawing translation projects, open for public comment from 8–18 September. They define four outcomes — voluntary suspension, time-limited suspension, voluntary withdrawal and mandatory withdrawal — and list eleven red lines that trigger mandatory withdrawal, including major safety defects, failure to correct problems, falsified data used to obtain approval, and unauthorised expansion of indications or patient groups. A department subject to mandatory withdrawal is barred from new projects for one year.
As of April 2026, 29 biomedical new-technology projects had been approved in the zone. The direction of travel is clear: stricter entry, and a real exit mechanism where none existed before.
Yes — that is the core of the zone's policy, and it applies to approved institutions inside Lecheng. It is not a general right to import anything: the drug has to be assessed and permitted for your case, through a hospital inside the zone. This is the main reason patients travel to Hainan.
The zone is the only place in mainland China where cellular and gene therapies can be applied clinically outside a standard drug registration, under its biomedical new-technology framework. But it is tightly regulated — particularly since the May 2026 regulations — and restricted to approved projects with defined eligibility. Any clinic offering it for a fee with a promise of cure is not operating within that framework. Neither we nor any honest provider can promise a cellular therapy will make you cancer-free.
No. Public hospitals inside the zone — Ruijin Hainan and West China Lecheng among them — treat patients under normal pipelines. What sets the zone apart is access to the special drugs and technologies, not the price level of routine care.
Start with the institutions named by the zone as international medical tourism receiving institutions, and with the public hospital branch campuses. Ask what specific approval covers the treatment you are being offered, and ask for it in writing. If a clinic cannot tell you which approved project or import permit applies to your case, treat that as a warning sign.
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