As the Hainan Free Trade Port expands rapidly, the Boao Lecheng International Medical Tourism Pilot Zone is leveraging the Real-World Study (RWS) policy to create an unprecedented fast track for innovative drugs and medical devices entering China.

Traditional regulatory approval follows a strict “prove first, then use” model. RWS fundamentally changes this approach by allowing products to be used while real-world clinical evidence is generated.

By March 2025, RWS has enabled 21 innovative drugs and medical devices to gain accelerated approval, shortening market entry timelines by an average of 2–3 years.

In addition, Lecheng’s special import approval process has been shortened from 27 working days to just 3–5 working days, increasing efficiency by nearly tenfold.

When combined with Hainan Free Trade Port incentives—including zero import tariffs, a 15% corporate income tax rate, and a 15% individual income tax cap for high-end talent—Hainan becomes an exceptionally attractive entry point for global pharmaceutical and medical technology companies.

While the incentives are substantial, compliance requirements are equally strict. Companies must plan carefully across several dimensions.

Proper planning of shareholding structures, contractual arrangements, and profit repatriation pathways is essential to avoid double taxation and ensure long-term tax efficiency.

Companies must ensure lawful employment structures, accurate income reporting, and correct tax treatment for expatriate personnel to maintain eligibility for individual tax incentives.

Enterprises must maintain compliant research documentation, drug and device traceability records, and fully traceable fund usage to withstand future audits and regulatory reviews.

RWS is one of the most powerful policy tools within the Hainan Free Trade Port framework. However, its benefits can only be realised through careful planning and precise execution.

FABC Accounting supports global healthcare enterprises with RWS eligibility assessments, tax planning, cross-border structuring, and audit-ready compliance frameworks.