Boao Lecheng Medical Zone 2026: Healthcare Market Entry Guide for Foreign Companies

Boao Lecheng is often introduced through the phrase Hainan medical tourism. That description is useful for understanding demand, but it is incomplete for an overseas healthcare company. The more important question is whether Lecheng can serve as a controlled China entry platform for a drug or device company, a hospital group, a clinical research provider, a specialist medical operator, a digital-health business or an investor.

The answer depends on the operating model. Lecheng brings together several exceptional policy channels: use of certain imported drugs and medical devices before general mainland approval, a real-world data application pilot, entity-specific zero-tariff treatment, opening measures for wholly foreign-owned hospitals, and investment access for specified human stem-cell and gene-technology research. None of those channels is a blanket exemption. Each has its own eligible entity, product scope, approval body, use boundary, evidence standard and supervision process.

This guide is written for corporate decision-makers. It explains what the zone is, which business models may fit, what approvals sit behind the policy headlines, and how to structure a market-entry work plan. It does not provide medical advice, evaluate treatments or recommend hospitals. Clinical choices must be made by qualified professionals on the facts of an individual case.

For the national company-law and market-entry context, read our 2026 guide to doing business in China alongside this sector guide.

1. What Boao Lecheng is — and what it is not

The Boao Lecheng International Medical Tourism Pilot Zone was approved by the State Council in 2013. It is located in Boao, Qionghai, on the east coast of Hainan, close to the Boao Forum for Asia area. The planned zone covers 9.96 km², and the airport and high-speed railway station are commonly described as about a ten-minute journey away.

Lecheng is China’s only national pilot zone built around a special medical policy package. More than 30 medical institutions operate in the zone across public, private and international models. The ecosystem includes seven frequently identified specialty clusters: rare diseases, oncology, ophthalmology, ear-nose-and-throat care, reproductive medicine, health examinations and medical aesthetics. Official Hainan materials also report cooperation with more than 180 drug and medical-device companies from 20 countries and regions, covering leading global manufacturers.

Those facts show concentration, not universal access. Lecheng is not a separate legal jurisdiction, an offshore hospital market or a route around Chinese regulation. Companies remain subject to national and Hainan rules on foreign investment, medical-institution licensing, drugs, devices, clinical research, human genetic resources, ethics, biosafety, advertising, personal information, cybersecurity, taxation, customs and employment.

It is helpful to view Lecheng as three overlapping platforms:

1. A regulated clinical-use platform. Qualified institutions may seek permission to use certain clinically urgent imported products not yet generally marketed in mainland China.
2. An evidence and localization platform. Eligible companies may work with institutions on real-world evidence, registration strategy, research collaboration, training and eventual local production.
3. A healthcare investment platform. Hospital groups, specialist operators, research organizations and supporting service providers can assess entity establishment and sector licensing under the foreign-investment framework.

The practical value is therefore not “special policy” in the abstract. It is the ability to connect a defined product or healthcare service to a qualified local institution, a compliant entity, an approval pathway and an evidence or commercial objective.

2. Four policy channels foreign healthcare companies should understand

2.1 Special access for clinically urgent imported drugs and devices

Lecheng’s best-known policy allows qualified medical institutions to apply for the import and use of certain drugs and medical devices that are approved overseas but not yet approved for general mainland marketing. In 2018, the State Council delegated relevant approval authority to Hainan, giving the province a more direct administrative role.

An early-2026 administrative snapshot counted 543 first-use approvals: 188 drugs and 355 medical devices. During 2025, the zone recorded 89 additional products used in China for the first time, an increase of nearly one-fifth from the prior year. Reported usage grew by 139% in that year, while cumulative use exceeded 190,000 patient visits or uses. Later totals can move as new products are approved, so these figures should be read as dated milestones rather than a current inventory.

The phrase “special access” needs precision. The medical institution, not an overseas manufacturer acting alone, applies within the regulated framework. The institution and relevant department must have the required qualifications and clinical capacity. The product must fit the clinically urgent need and approval scope. Import, storage, prescribing, use, adverse-event management and, where permitted, take-home arrangements are supervised. A three-tier risk classification and end-to-end one-item-one-code traceability system support oversight.

Official reporting has described a process from application to use as fast as 1.6 days in reported cases. That is a reported case outcome, not a standard processing period. A company’s plan should allow for product assessment, institution matching, documentation, translations, logistics, customs, ethics or technical review, and case-specific questions.

For a foreign manufacturer, the policy can support several objectives:

• a controlled first-use pathway with an eligible medical institution;
• physician training and product-use governance within the approved scope;
• collection of regulated safety and performance information;
• assessment of demand before a broader China registration or localization decision; and
• structured engagement with regulators and clinical partners.

It does not confer national marketing authorization. Promotion must not imply that Lecheng access means a product is approved for sale throughout China. Patient recruitment, advertising claims and online communications should be reviewed against the applicable healthcare and advertising rules.

2.2 Real-world evidence as part of a China regulatory strategy

Lecheng’s real-world data application pilot began in 2019. Its purpose is to explore how data generated from lawful product use in the zone can support drug or medical-device regulatory decisions. By an official September 2025 milestone, 21 products had used the Lecheng real-world evidence channel to support accelerated China market access. A historical policy snapshot also reported that 3 products had used related evidence in support of access to the national reimbursement catalogue. These are dated milestones; current official totals should be checked when a project begins.

Real-world evidence, or RWE, is not simply a collection of hospital records. A useful regulatory project begins with the decision question: what claim, registration application or evidence gap is the sponsor trying to address? The protocol, data elements, patient population, endpoints, comparison method, source-data quality, governance, statistics and audit trail must be designed accordingly.

Foreign companies should separate four layers:

• Special-use authorization: whether the product may be used in Lecheng under the relevant approval.
• Study governance: whether the proposed data collection requires ethics, institution, human genetic resources, personal-information, cybersecurity or other review.
• Evidence fitness: whether the dataset and analysis can answer the intended regulatory question.
• National submission: whether the National Medical Products Administration accepts the evidence within the full registration package.

The zone can bring these layers closer together, but it does not collapse them into a single decision. A sponsor should involve regulatory, medical, biostatistics, data-management, quality, legal and privacy teams before the first case is enrolled. Contracting must allocate responsibilities for data quality, safety reporting, monitoring, intellectual property, publication, cross-border access and inspection readiness.

For an early-stage product company, the strongest reason to consider Lecheng is not speed by itself. It is the potential to align controlled clinical use with a China evidence plan, while learning whether physicians, institutions and the market see a genuine need for the product.

2.3 Zero-tariff treatment for qualifying imported drugs and devices

In September 2024, five central authorities issued a dedicated zero-tariff policy for drugs and medical devices in Lecheng. The first shipment under the mechanism arrived on 31 December 2024. Under the published framework, eligible entities were recognized independent-legal-person medical institutions, medical universities and pharmaceutical research institutes registered in the zone.

The covered scope included imported drugs and medical devices already registered in China and, under the special Lecheng rules, products not yet registered domestically but approved for import and use in the zone. Vaccines were excluded from the latter category. Where all conditions were met, import duty and import-stage value-added tax could be exempted.

An early-2026 operating snapshot recorded 18 approved institutions and 71 product items, with qualifying goods worth more than RMB 460 million and tax reductions exceeding RMB 60 million. These figures show that the mechanism was being used; they do not mean that every Lecheng company or every imported healthcare product is eligible.

The entity rule is especially important. A representative office, distributor, ordinary consulting WFOE or manufacturer outside the recognized classes should not assume it can import under the healthcare-specific policy. The use and circulation of the goods are also controlled. Customs classification, valuation, product approval, importer identity, inventory, destination, consumption and any movement outside the permitted setting must match the current rules.

Hainan began island-wide special customs operations on 18 December 2025. The broader Hainan Free Trade Port tax system and the Lecheng healthcare mechanism must therefore be read together under the rules in force at the time of import. Authorities have indicated continued refinement and coordination of medical-product policies after customs operations began. Before pricing a shipment, verify:

• whether the importing entity is currently recognized;
• whether the product is within the operative scope or catalogue;
• which approval supports import and use;
• which taxes are exempt and which costs remain;
• how inventory and one-item-one-code traceability will be managed; and
• what happens if goods, samples, data or equipment move beyond Lecheng or Hainan.

Our Hainan import-export and zero-tariff guide explains the wider customs framework. The medical-product policy has its own subject and use conditions, so the two should not be treated as interchangeable.

2.4 Foreign-owned hospitals and specified biomedical R&D

China’s September 2024 opening measures created two distinct healthcare opportunities relevant to Hainan.

First, the pilot permits qualifying foreign investors to establish wholly foreign-owned hospitals in Hainan. Hainan issued its implementation arrangements in January 2025, with projects in Lecheng routed through the competent provincial bodies and the Lecheng administration. Provincial drug-regulatory measures issued in December 2025 further stated that eligible wholly foreign-owned hospitals may apply to use special licensed products in Lecheng.

This is an application route, not open entry for every investor or every hospital type. The national pilot scheme requires, among other matters, a foreign corporate investor with healthcare investment or management experience and an ability to provide suitable medical technology, equipment, management concepts or services. The permitted institution types, hospital level, staffing composition and data infrastructure are restricted. The published scheme also requires Chinese personnel to account for at least half of management and medical staff, and medical data must be stored on domestic servers under the applicable rules.

Second, the opening pilot permits foreign-invested enterprises in Hainan to undertake specified development and application of human stem cell and gene diagnosis-and-treatment technologies for product registration and production. This sits inside a highly regulated framework covering foreign-investment scope, clinical and product regulation, ethics, human genetic resources, biosafety, data and institutional qualifications.

Lecheng separately developed a strict medical-new-technology review pilot. From March 2025, three batches covering 11 projects were approved. The first review reportedly received more than 200 submissions and approved 3, or roughly 3%, following multidisciplinary review across seven fields. These numbers indicate selectivity, not treatment results. They should never be used to imply clinical effectiveness.

For a foreign biomedical company, the correct first question is not “Is stem cell or gene therapy open?” It is: Which exact activity, entity, product, material, data flow and clinical setting are proposed, and which authority approves each one? Research, product development, clinical application, hospital operation, sample export and marketing are different regulated activities.

The 2024 opening also supports international teleconsultation and international multicentre clinical work. Digital-health and research companies should nevertheless map physician location, medical responsibility, platform function, personal-information handling, cross-border data, medical records, cybersecurity and device-software regulation before launching a service.

3. Which foreign healthcare business models may fit Lecheng?

Lecheng is not only for hospital owners. The policy stack can support several forms of market entry, provided the entity and licences match the actual activity.

Business model	Potential Lecheng role	Main gating questions
Overseas drug or device manufacturer	Institution partnership, special-access introduction, RWE planning, training, registration and localization study	Product eligibility, institution fit, import approval, pharmacovigilance or vigilance, data quality, national registration plan
International hospital group	Wholly foreign-owned hospital pilot, specialist institution, management or clinical collaboration	Investor experience, permitted hospital type and level, medical licence, staffing, premises, equipment, data and governance
CRO or evidence-services provider	Protocol design, data management, statistics, monitoring, RWE and multicentre study support	Service scope, contracts, quality system, human genetic resources, ethics, privacy, cybersecurity and cross-border access
Specialist clinic operator	Ophthalmology, ENT, reproductive health, examinations, medical aesthetics or another permitted specialty	Medical-institution category, physician qualifications, service catalogue, equipment, advertising and foreign-investment restrictions
Digital-health company	Hospital workflow, regulated software, teleconsultation infrastructure, data tools and patient-service platforms	Whether software is a medical device, who delivers medical services, data localization, algorithm compliance, security and consent
Medical research or education institution	Joint research, training, laboratory or evidence partnership; possible zero-tariff assessment for a qualifying recognized entity	Legal-person status, recognition, research scope, ethics, biosafety, equipment use and customs supervision
Special medical food or health-food company	Product assessment, temporary import pathway or institutional collaboration under the applicable special-food rules	Product classification, registration or temporary-use basis, importer, institution, labeling, advertising and food regulation
Healthcare investor or fund	Hospital, platform, R&D or service investment; strategic partnerships and project financing	Negative list, fund structure, healthcare licences, valuation, governance, related-party transactions and exit route

Hainan delegated approval authority for temporary import and use of certain special medical foods and health foods in 2024, and the first products later entered the zone. That policy is product- and institution-specific. A food, supplement or nutrition company should not present an ordinary health product as a medical product or assume that a foreign approval is sufficient for sale in China.

A representative office is usually not enough

A foreign company may consider a representative office for liaison, but it cannot generally conduct revenue-generating healthcare operations. A service, research, import or clinical model normally needs a Chinese legal entity plus the applicable industry permissions. Distribution may also require a qualified domestic partner, a foreign-invested commercial enterprise or a more specific regulated entity.

4. A market-entry and licensing roadmap

A foreign healthcare project should run corporate setup and sector approval as one coordinated workstream. Registering a broad consulting company first and asking about medical permissions later can create rework.

Step 1 — define the regulated activity

Write a one-page operating map covering products, services, users, paying customers, medical decisions, data, laboratories, samples, staff and cross-border flows. Separate what the company will do itself from what a hospital, importer, CRO, distributor or technology vendor will do.

Then classify the model:

• medical institution or non-medical service company;
• drug, device, software, food or general service;
• R&D, clinical use, import, distribution, promotion or manufacturing;
• online platform, teleconsultation infrastructure or direct medical service; and
• domestic-only data or cross-border data access.

This classification drives the negative-list review, business scope and licence map.

Step 2 — screen foreign-investment access

China applies pre-establishment national treatment plus a foreign-investment negative list. Activities outside the list may generally be foreign-owned, subject to ordinary sector regulation. A medical business can still face additional restrictions under the wholly foreign-owned hospital pilot, healthcare rules, human genetic resources regulation or another specialist regime.

Create a legal-activity matrix for each revenue line. Do not rely only on the proposed company name. Regulators assess what the business actually does.

Step 3 — engage Lecheng before fixing the structure

For a project seeking admission, land, premises, a medical-institution route, special-product access or an RWE partnership, engage the Lecheng administration and relevant regulator early. A pre-application discussion can identify whether the project fits the zone’s positioning and which submission route applies.

Bring a concise package: investor background, ownership, management experience, proposed activity, target products or specialties, capital plan, premises need, staffing, technology, compliance system, China registration objective and expected local contribution. Treat informal feedback as guidance, not an approval.

Step 4 — design and register the entity

The entity plan normally covers shareholder identity, legal representative, directors or board, registered capital, the five-year contribution schedule under the current Company Law, business scope, registered address and beneficial-owner reporting. A healthcare project may need more capital, premises or professional staffing than an ordinary consultancy even where no universal statutory minimum applies.

After registration, complete company seals, bank account, tax registration and accounting setup. The broader steps are explained in our doing-business-in-China guide.

Step 5 — obtain sector permissions before operating

The required stack depends on the model. It may include medical-institution establishment and practice permissions, diagnosis and treatment subjects, pharmacy or device permissions, import and special-use approvals, clinical-trial or RWE governance, ethics review, human genetic resources procedures, biosafety controls, internet healthcare permissions, cybersecurity filings, personal-information impact assessment, advertising review or food approvals.

A business licence is only the corporate layer. It should not be described to clients or investors as permission to begin regulated medical activity.

Step 6 — build quality, data and safety systems

Lecheng’s policy advantages depend on traceability and controlled use. Before launch, allocate responsibility for supplier qualification, product release, cold chain, inventory, prescribing, adverse events, recalls, complaints, records, training, data access, incident response and regulator reporting.

For special products and RWE, the operating system is part of the market-entry asset. A company that cannot show reliable data and safety governance will struggle to turn initial access into a national registration or long-term partnership.

Step 7 — test the commercial model without overstating policy

Build a financial model that separates normal revenue from conditional benefits. Use written assumptions for product volume, institution fees, import taxes, logistics, clinical or research costs, staffing, data infrastructure, rent and professional services. Run a downside case in which a policy benefit, product approval or project timetable differs from the initial plan.

5. Tax, customs and people: the general Hainan layer

Lecheng companies operate inside the Hainan Free Trade Port, but zone admission does not automatically produce a preferred tax rate.

Corporate income tax

The current Hainan FTP 15% corporate income tax policy runs through 31 December 2027 for qualifying encouraged-industry enterprises with substantive operations in Hainan. The enterprise generally needs a main business within the applicable encouraged catalogue and at least 60% of total revenue from qualifying main activities. Substantive-operation rules examine personnel, premises, management, accounts, assets and business activity; current implementation also uses a minimum local-staff benchmark of at least 3 people for the relevant tests.

A healthcare label is not enough. The exact activity must match the catalogue, and the revenue and substance conditions must be evidenced. See our Hainan tax and location comparison before using the 15% rate in a budget.

Customs and imported products

The Lecheng medical zero-tariff channel has narrower entity and use conditions than Hainan’s general Free Trade Port framework. A product may be eligible under one mechanism but not another. Obtain a written classification and transaction map covering importer, seller, buyer, product approval, HS code, valuation, destination, permitted use and later circulation.

The start of island-wide special customs operations in December 2025 changed the operating environment. Our complete Hainan Free Trade Port guide provides the broader framework, but current medical-product rules still require project-specific confirmation.

Entry, work permits and staffing

Hainan’s visa-free policy allows eligible ordinary-passport holders from 61 countries to enter for up to 30 days for permitted purposes including business visits and medical treatment. It does not authorize employment. An investor can use a qualifying visit to inspect Lecheng, meet institutions and discuss a project, but working in the Chinese entity requires the appropriate immigration status.

Foreign employees are managed under work-permit categories A, B and C. The employing entity, position, qualifications, salary, experience and supporting documents matter. A founder’s shareholding does not by itself authorize work. Plan the immigration file together with hiring and company setup; our China work visa and work permit guide covers the sequence. For visit eligibility and permitted activities, use the Hainan visa-free policy guide.

Healthcare staffing adds a second layer. Doctors, nurses, pharmacists and other professionals may need Chinese practice registration or approved short-term practice arrangements. The hospital pilot also includes local-staff composition requirements. Verify profession-specific rules before issuing offers or announcing services.

6. Decision tests by company type

Drug and device companies

Lecheng may fit when an eligible product addresses a genuine clinical need, a qualified institution is willing to lead the application, and the sponsor has a China regulatory objective beyond one-off supply. The strongest projects connect special access, safety governance, physician training, RWE design and national registration.

It may not fit when the company wants ordinary distribution without national approval, lacks a suitable institutional partner, cannot support vigilance and traceability, or expects Lecheng access to authorize promotion across China.

Hospital and specialist-care groups

Lecheng may fit a group with documented healthcare operations, suitable technology and management systems, a permitted hospital or specialty model, and willingness to build a locally staffed institution. The wholly foreign-owned hospital pilot can provide ownership control, but licence, personnel, premises, data and clinical-governance requirements remain central.

It may not fit a passive investor expecting to outsource all medical responsibility or an operator whose proposed service falls outside the permitted institution type.

CRO, RWE and data companies

Lecheng can be relevant to organizations with regulatory-grade protocol, quality, statistics and data-management capacity. A credible provider should understand both the clinical question and the China compliance environment.

It may not fit a generic analytics vendor that cannot meet audit, source-data, privacy, security, human genetic resources or inspection requirements. Cross-border dashboards and remote access need review before implementation, not after data collection begins.

Digital health and telemedicine

The zone’s support for international teleconsultation and multicentre collaboration can create partnership opportunities. A technology provider may supply workflow, scheduling, documentation, decision-support, monitoring or secure communications.

The model must still answer who is practising medicine, where the physician and patient are located, whether the software is a regulated device, where data is stored, who controls the medical record, and whether overseas access is permitted. Technology does not remove medical responsibility.

Medical aesthetics, examinations and reproductive health

These are recognized Lecheng specialty clusters, but each is strongly regulated. Investors should assess institution category, diagnosis and treatment subjects, practitioners, products, equipment, consent, advertising and data. Consumer demand alone is not a licensing basis.

7. Due diligence before committing capital

Before signing a lease, forming a joint venture or announcing a China launch, request evidence for the following items:

Policy fit

• the official rule and current implementation document supporting the proposed activity;
• the responsible authority and application route;
• the eligible entity, product and use conditions; and
• whether a cited number or policy is a current rule or a historical result.

Institution or partner

• legal identity, ownership and medical or research licences;
• approved diagnosis and treatment subjects or research scope;
• relevant department qualification and prior regulatory record;
• ethics, quality, data and safety systems; and
• ability to perform the agreed role without relying on subcontracting that changes the approval basis.

Product and evidence

• overseas approval and manufacturing documentation;
• China classification and registration strategy;
• special-access eligibility and importer plan;
• RWE question, protocol feasibility, data ownership and regulator engagement; and
• vigilance, recall and liability allocation.

Entity and finance

• negative-list and licence analysis;
• capital needs and five-year contribution plan;
• tax eligibility tested separately from zone admission;
• related-party pricing and payment routes; and
• customs treatment based on the actual transaction chain.

People and data

• local and foreign staffing plan;
• professional registration and work-permit route;
• personal-information roles, consent and retention;
• domestic storage, remote access and cross-border transfer; and
• cyber, incident and business-continuity controls.

The outcome should be a written go/no-go memo with unresolved questions, owners and decision dates. A zone tour or policy presentation is useful context, but it is not a substitute for this evidence.

8. A practical sequence for a foreign healthcare project

Phase 1 — fit assessment. Define the activity, product, target customer, medical partner, evidence objective and China commercial plan. Screen foreign-investment access and decide whether Lecheng adds a real regulatory or operational advantage.

Phase 2 — authority and partner engagement. Meet the Lecheng administration, relevant regulator and potential institutions with a concise project dossier. Record which conclusions are confirmed, which are preliminary and which require a formal filing.

Phase 3 — entity and licence architecture. Choose a WFOE, permitted wholly foreign-owned hospital, joint venture, research collaboration, distributor or another lawful structure. Align business scope, capital, premises, contracts and approvals.

Phase 4 — operational readiness. Build quality, pharmacovigilance or device-vigilance, data, ethics, customs, accounting, HR and incident-response systems. Train staff and partners before the first import, study or patient-facing service.

For a fact-specific entity, licence and partner map, review our China market-entry consulting service and contact the Hainan Setup team. We can help organize the corporate and administrative workstream; final approvals remain with the competent authorities.

Frequently Asked Questions

What is the Boao Lecheng International Medical Tourism Pilot Zone?

Boao Lecheng is a 9.96 km² national healthcare pilot zone in Qionghai, Hainan. Approved by the State Council in 2013, it combines medical services, special access to certain imported drugs and devices, real-world evidence work, healthcare research and international investment pilots. It remains subject to Chinese healthcare, investment, data, tax and customs regulation.

Can a foreign company set up a wholly foreign-owned hospital in Hainan?

Potentially. A September 2024 national pilot opened wholly foreign-owned hospitals in Hainan, and the province issued implementation arrangements in January 2025. An investor in Lecheng applies through the competent Hainan bodies, including the Lecheng administration, and must satisfy the applicable investor, hospital type, personnel, data, premises, licence and operating conditions. Foreign ownership does not create automatic approval.

What are special licensed drugs and devices?

They are imported products that are not yet approved for general mainland marketing but may be imported and used by qualified Lecheng medical institutions for clinically urgent needs after the required approvals. Controls apply to the product, institution, department, physician, import, storage, use, safety and traceability. Access in Lecheng is not nationwide marketing authorization.

What is the zero-tariff policy for imported drugs and medical devices in Lecheng?

The 2024 policy applied to recognized independent-legal-person medical institutions, medical universities and pharmaceutical research institutes registered in Lecheng. Qualifying products could be exempt from import duty and import VAT under the stated conditions; vaccines were excluded from the special-product category. Because island-wide special customs operations began in December 2025, verify the current entity recognition, product scope, use and customs rules before importing.

How does real-world evidence help foreign drug and device companies enter China?

Lecheng’s RWE pilot allows regulated data from authorized product use to be evaluated as part of a China registration strategy. The sponsor still needs a suitable question, protocol, data quality, governance and complete evidence package, and the national regulator decides whether the evidence is acceptable. Participation is not equivalent to national product approval.

Are stem cell and gene therapy activities open to foreign investment?

The September 2024 pilot permits foreign-invested enterprises in Hainan to conduct specified development and application of human stem-cell and gene diagnosis-and-treatment technologies for product registration and production. The activity remains subject to registration, ethics, biosafety, human genetic resources, data, clinical and sector approvals. Lecheng’s separate 11-project medical-new-technology pilot also uses strict multidisciplinary review. This policy description is not an assessment of any treatment.

How do foreign healthcare companies register a business in Hainan or Lecheng?

Start by screening the negative list, classifying the regulated activity and confirming the Lecheng or partner route. Then design and register the foreign-invested entity, open bank and tax accounts, and complete the healthcare, drug, device, research, food, data or other permissions before operating. A business licence alone is not a medical-operation licence.

What tax and visa benefits apply to medical companies and their staff?

A qualifying encouraged-industry company with substantive operations in Hainan may assess the 15% CIT policy through 31 December 2027, subject to the catalogue, at least 60% qualifying main-business revenue and other conditions. Eligible visitors from 61 countries may use Hainan’s 30-day visa-free route for permitted short visits. Employment requires the appropriate work permit and residence status.

Official and authoritative sources

• State Council approval and national pilot-zone background — The State Council
• Lecheng administration profile and operating ecosystem — Hainan Provincial Government
• Special drug and device approval background — Hainan Medical Products Administration
• Real-world evidence milestone — Hainan Medical Products Administration
• December 2025 measures on special products, RWE and foreign-owned hospitals — Hainan Medical Products Administration
• Zero-tariff policy explanation — Ministry of Finance
• Lecheng zero-tariff policy scope — Hainan Provincial Government
• Foreign-investment opening measures for biomedical technology and hospitals — Ministry of Commerce
• Wholly foreign-owned hospital pilot conditions — Ministry of Commerce
• Lecheng drug and device policy implementation support — Hainan Medical Products Administration
• Hainan Free Trade Port special customs operations and Lecheng update — Hainan Provincial Government

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Disclaimer: This article is for general B2B information only. It is not medical, legal, tax, regulatory or investment advice and does not evaluate any product, institution or treatment. Policies, catalogues, statistics and implementation can change. Product access, hospital establishment, RWE use, tax treatment, customs treatment, company registration, licences and immigration depend on the facts and decisions of the competent authorities. Obtain current, project-specific advice before acting.