NLSP | Hainan Boao Lecheng

Hainan Boao Lecheng International Medical Tourism Pilot Zone

Hainan Boao Lecheng International Medical Tourism Pilot Zone (HBL) is China’s only designated national medical zone that has been granted preferential policies and incentives to create a world-class international medical destination and cluster for advanced medical treatment, rehabilitation, medical R&D, and technological innovation in China.

It offers a special fast-track approval procedure that makes it easier and quicker to sell, register, import, and use "Innovative" medtech, healthtech, drugs, and rehabilitation equipment in need by the HBL hospitals without an NMPA approval.

Criteria: 1) Product cannot have been approved in mainland China but needs CE/FDA/PMDA approval, 2) Product shall be "innovative" and cannot be replaced by an already approved predicate in China, and 3) Product shall be used for a specific medical purpose at designated medical institution.

As of September 2024, 431 medical products (270 medical devices + 161 drugs) have been approved by Hainan MPA for exclusive use at HBL.

Moreover, it is the first place in China where it is possible to conduct Real-World Data (RWD) Studies of the use of medical devices and drugs imported under the fast-track approval procedure that can supplement the application for the NMPA registration which can accellerate the approval process to sell in all of China.

As of April 2024, 30 licensed medical devices and drugs have been included in the RWD Program in which 13 medical products have so far obtained an NMPA registration by using RWD studies at HBL.

CURRENT STATUS

When fully developed by 2035, Hainan Boao Lecheng is planned to cover 21 km2 with a total of 3 km2 of constructed land. Total construction costs are estimated at RMB 100 billion (USD 16 billion).

Today, 25 hospitals / medical centers & 6 medical service centers are in operation with 3 new hospitals still to open in 2024, and another 10-15 more planned.

When completed, it will provide 12,000 hospital beds, employ 28,500 medical personnel including 3,500 R&D staff.

In the first half of 2024, a total of 209,000 medical tourists were welcomed, an increase of 49.6% year-on-year.

LOCATION - GETTING THERE

Located by the Wanquan River near Qionghai City about 90 kilometres south-east of Haikou, the provincial capital of Hainan.

Lies 7.3 kilometres from Boao Airport (15 minutes by car), and 3.7 kilometres from Boao Railway Station (10 minutes by car) with high-speed train links around Hainan.

Driving distance from Haikou Meilan Airport to Boao is 35 minutes by high-speed train and 1 hour and 20 minutes by car.

Flying time from Beijing to Haikou is 4 hours while it is 2 hours and 45 minutes from Shanghai and 1 hour and 15 minutes from Guangzhou, Shenzhen, and Hong Kong. Direct flights from Shanghai to Boao Airport take 3 hours and 20 minutes.

Hainan Boao Lecheng International Medical Tourism Pilot Zone

It offers a special fast-track approval procedure that makes it easier and quicker to sell, register, import, and use "Innovative" medtech, healthtech, drugs, and rehabilitation equipment in need by the HBL hospitals without an NMPA approval.

Criteria: 1) Product cannot have been approved in mainland China but needs CE/FDA/PMDA approval, 2) Product shall be "innovative" and cannot be replaced by an already approved predicate in China, and 3) Product shall be used for a specific medical purpose at designated medical institution.​

​As of September 2024, 431 medical products (270 medical devices + 161 drugs) have been approved by Hainan MPA for exclusive use at HBL.

​As of April 2024, 30 licensed medical devices and drugs have been included in the RWD Program in which 13 medical products have so far obtained an NMPA registration by using RWD studies at HBL.

CURRENT STATUS

Criteria: 1) Product cannot have been approved in mainland China but needs CE/FDA/PMDA approval, 2) Product shall be "innovative" and cannot be replaced by an already approved predicate in China, and 3) Product shall be used for a specific medical purpose at designated medical institution.

As of September 2024, 431 medical products (270 medical devices + 161 drugs) have been approved by Hainan MPA for exclusive use at HBL.

As of April 2024, 30 licensed medical devices and drugs have been included in the RWD Program in which 13 medical products have so far obtained an NMPA registration by using RWD studies at HBL.