Hainan Island’s Special Access Program for Medical Devices

On May 1, 2023, Hainan Province reaffirmed its special access program to for the importation of urgently needed drugs and medical devices into the Boao Lecheng International Medical Tourism Pilot Zone. This allows the clinical use of qualified overseas medical devices that have not received NMPA approval if they are clinically essential and lack alternatives.

Medical Devices that Qualify for the Hainan Special Access Program:

Devices must meet one of the following criteria

• Address a clinically urgent need.
• Treat rare diseases.
• Prevent or treat serious life-threatening diseases with no existing effective treatment.
• Offer significant clinical advantages for serious life-threatening diseases.
• Feature major technological innovations with superior performance.
• Be approved by the Hainan health administrative authority.

Application Process: Applications must be submitted through one of the 28 hospitals in the Pilot Zone. Initial steps include contacting potential hospitals and forming agreements. A flow chart outlining the application procedure is attached. A distributor in China should find a suitable hospital and establish an agreement, after which Asia Actual can assist with the application process.

Boao Lecheng International Medical Pilot Zone Program: The Hainan special access program provides access to 28 state-of-the-art hospitals currently operational with more under construction. Approval under this program allows products to be sold in these hospitals without NMPA registration.