Hainan Boao Pilot Zone allows overseas unapproved medical devices, IVDs, drugs, with clinical urgency status to be used in China. It does NOT require local type testing or significant burden of proof as the national approval. While commercializing and selling their products, manufacturers can collect Real-World Data (RWD) in Hainan as local clinical evidence in China to support their national NMPA registration approval. The special program might fasten their China market access to 4 months.
To further refine this pathway, the Hainan Medical Products Administration, the Provincial Health Commission, and the Lecheng Administration jointly issued the “Implementation Measures for Pre‑Review Services of Clinically Urgent Imported Drugs and Medical Devices” on March 24, 2026.
These rules aim to optimize approval procedures, improve efficiency, and better meet patient needs while upholding rigorous safety and quality standards. The pre‑review mechanism is a voluntary front‑end service that allows applicants to initiate regulatory assessment before finalizing internal product adoption, in hope to shorten the subsequent approval timeline.
Hainan Boao Pilot Zone published the “List of Drugs and Medical Devices Imported Overseas” on May 24, 2025. Since October 2020, Boao has introduced 477 drugs and medical devices, covering 28 departments including oncology, ophthalmology, cardiovascular rehabilitation, aesthetics, and diagnostics, benefiting more than 120,000 patients. For the list of devices, please email info@ChinaMedDevice.com. We can help you with feasibility study entering your devices to Hainan.
Click HERE to see Hainan urgent use policies in 2025: Accelerated Market Access Pathway through RWD, Out-of-Zone Use, and Zero-Tariff Measures
Click HERE for our recorded webinar on Hainan policies
Pre‑Review Service: Eligibility and Documentation
The pre‑review prioritizes clinically urgent needs and follows principles of scientific rigor, risk control, and efficiency. Eligible products include those already approved in ICH or IMDRF member countries, treatments for rare diseases, or therapies for life‑threatening conditions with no effective alternatives. Applicants can be medical institutions within the zone, Chinese subsidiaries of overseas marketing authorization holders, or authorized agents.
Key application materials typically include:
- A pre‑review application form and qualification certificates.
- Proof of overseas marketing authorization and, for devices, evidence of GMP compliance.
- Product packaging, labeling, and instructions with actual sample images.
- A clinical urgency justification and superiority summary (covering mechanism, indications, global safety data, adverse event profiles, and ethnic risk‑benefit assessment).
- A commitment letter attesting to the authenticity, legality, and traceability of all submitted data.
Products intended for real‑world data (RWD) studies are given priority for pre‑review, and applicants may choose to submit additional materials as needed.
Review Process and Catalog‑Driven Streamlining
The review follows a clearly defined two‑step procedure. First, the Health Commission assesses clinical urgency and issues a guidance opinion within 3 working days. Second, the Medical Products Administration makes a final decision within 7 working days (excluding expert meetings), based on technical evaluations and pharmacovigilance analyses. For products that already meet certain criteria—such as NMPA‑approved for urgent use, listed in the Greater Bay Area catalog, or simultaneously marketed in the US, the EU, and at least one Asian ICH/IMDRF member country—a simplified written review may be applied, further shortening the process.
The system offers several operational advantages:
- Catalog reuse – Once a product is added to the pre‑reviewed catalog, subsequent import applications by Lecheng institutions can directly reuse previously submitted materials; authorities will not re‑review already verified content.
- Minimal extra documentation – Only an updated adverse event report (with a retrieval date no earlier than three months before the new application) is required, eliminating duplicate workload.
- Dynamic catalog management – Products are removed if they no longer meet urgency criteria, face safety risks, become approved in mainland China, or involve fraudulent information.
- Continuous oversight – Applicants must promptly report any major changes in quality, manufacturing, or safety signals, ensuring ongoing regulatory control.
By integrating this pre‑review service with the existing RWD framework, the program offers a faster, more predictable route for bringing innovative, urgently needed medical products to Chinese patients while maintaining strict safety oversight.