Hainan government released the “Regulations on the Administration of Urgent Use Imported Drugs and Medical Devices in the Boao Lecheng International Medical Tourism Pilot Zone of Hainan Free Trade Port” on March 28, which will be effective on May 1, 2023. This special policy allows early commercial access to China Boao a lot faster than the national approval. It does NOT require local type testing or significant burden of proof as the national approval. Not all products fit in this special zone.
Imported Medical Devices for clinically urgent use refer to devices that are urgently used in medical institutions in the Pilot Zone. The devices have been approved for sale overseas, and have no same products approved by China NMPA.
Hainan Boao Pilot Zone allows overseas unapproved medical devices, IVDs, drugs, with clinical urgency status to be used in China. For overseas manufacturers, while commercializing and selling their products, they can collect RWD through RWS 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.
Timeline & Review Focus for Imported Drugs and Medical Devices in Hainan
Hainan Provincial Health Commission (HHC) is responsible for assessing the qualifications of medical institutions that apply for clinically urgent use of imported medical devices and drugs. After accepting the application, HHC shall decide whether products meet the qualifications within 10 business days.
After further review whether products are applicable to clinically urgent use, and whether departments of medical institutions or medical team meet clinically urgent use qualifications, HHC shall issue an assessment opinion within 5 business days.
Based on the assessment opinion from HHC, Hainan provincial MPA(HMPA) will further review the overseas listing status of products and their adverse reactions or events. And HMPA will grant administrative licensing to overseas manufacturers within 7 business days.
Application and Approval
Designated medical institutions are responsible for the safety risks of clinically urgent use products.
Designated institutions shall meet four requirements:
- Tier-3A hospital, with departments qualified for clinically urgent using drugs and devices.
- Have safeguard measures and management systems for circulation, transportation and storage that meet the features and instructions for use of the drugs and devices.
- Have adverse reactions or events monitoring institutions for drugs and devices with full-time personnel, who have received professional training to perform monitoring duties.
- Have emergency plans and response capabilities for serious adverse reactions or events that may occur in the usage.
Despite the official review days are only 22 working days, the hospital qualification, documentation, EC approval, multiple contracts negotiation and logistics do take a few months. It is a lot faster than the national approval.
I am interested to hear your experience about clinically urgent use policy in Hainan Boao to support your China NMPA approval. Please email me at gpalma@ChinaMedDevice.com.
View our recorded webinar on Hainan policies.