Nordic Life Science Platform

FAST-TRACK CHINA ENTRY

- Medtech, Pharma, Rehabilitation,
and Welfare Technology

On 12 October 2023, the Danish Life Science Cluster, Nordic Life Science Partners, and the Lecheng Administration signed a Strategic Cooperation Agreement in Copenhagen within health and life science that was witnessed by Ms. XIE Jing, Vice Governor of Hainan Province.

China Market Access via Fast-track Approvals and Real-World Data Studies for Medical Devices & Medicines at Hainan Boao Lecheng International Medical Tourism Pilot Zone

About Us - Mission

About Us - Purpose & Mission

The purpose of the Nordic Life Science Platform (NLSP) is to give European/Nordic Life Science & Welfare Technology companies a more safe, efficient, and easier access to China's rapidly expanding healthcare market by taking advantage of the preferential policies and opportunities at Hainan Boao Lecheng International Medical Zone that is part of the newly launched Hainan Free Trade Port that covers all of Hainan Island.

Our mission is to match the demand for innovative medical products and solutions by the hospitals in Hainan Boao Lecheng with the supply of European/Nordic life science companies for the benefit of Chinese patients, and that way help develop new market opportunities in China.

Through NLSP, Hainan Boao Lecheng serves as a gateway and stepping-stone to the rest of Mainland China's Healthcare Market.

To explore these market opportunities further, the Nordic Life Science Partners ApS has established a Partnership with the Danish Life Science Cluster, Innovation Center Denmark in Shanghai, and Trade Council in China.

Concept

Concept - One-Stop Service

Although China is the world’s second largest market for both medical devices and medicines, many European/Nordic life science companies hold back from starting exports or own sales in China because of lack of market knowledge and (perceived) entry barriers, and thus consider it too difficult and risky. This cuts them off from a large growth market.

To lower the entry barriers, we have gathered a team of experts with many years of know-how and experience from advising and assisting European/Nordic companies entering and operating in China.

NLSP is a one-stop service platform that helps European/Nordic companies to explore and enter China's healthcare market. We reduce the challenges and time-to-market by offering companies expert advice and supporting services.

Our Offering

Offering - Step-by-Step Entry Model

NLSP delivers a Step-by-Step Market Entry Model that supports companies all the way but also give them the option to pause after each step of the process to decide their next move into the Chinese market.

With NLSP and our local partners in Hainan, our experienced team will assist Nordic life science & welfare technology companies to enter China's healthcare market and to take advantage of the preferential policies and opportunities at Hainan Boao Lecheng.

We offer expert advice and supporting services such as project management, legal assistance, IPR protection, matchmaking, fast-track approval, CRO partnering for RWD study, market research, distributor search, company set-up, and product registrations.

STEP-BY-STEP FLOW CHART

Hainan Boao Lecheng Intl. Medical Zone

Hainan Boao Lecheng International Medical Tourism Pilot Zone is a special medical zone in China that has been granted preferential policies and incentives with the aim to create a world-class international medical destination and cluster for advanced medical treatment, professional rehabilitation, medical R&D, and technological innovation in China.

It offers a special fast-track approval procedure that makes it easier and quicker to register, import, sell and sell "Innovative" medical devices and medicines in need by the hospitals in Hainan Boao Lecheng that are not yet registered in China.

As of April 2024, 389 medical products have been approved by Hainan MPA for exclusive use in Hainan Boao Lecheng.

Criteria: 1) Product cannot have been registered in 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.

Moreover, it is the only place in China where it is possible to conduct Real-World Data (RWD) Studies of the use of medical devices and medicines 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, 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, 23 hospitals/medical centers & 6 medical service centres are in operation with 5 new hospitals still to open in 2024, and ten more planned.

When completed, it will provide 12,000 hospital beds, employ 28,500 medical personnel including 3,500 R&D staff, and by 2025 provide 1.5 million medical consultations per year. In 2023, a total of 300,000 medical tourists were welcomed.

Hainan