Nordic Life Science Platform

FAST-TRACK CHINA ENTRY

- Medtech, Healthtech, Rehabilitation, Welfare Technology, and Medicine

China Market Access via Fast-track Approval Procedures for Medical Devices & Medicines at Hainan Boao Lecheng International Medical Tourism Pilot Zone

About Us - Mission

The Nordic Life Science Platform (NLSP) has been established to give Nordic Life Science & Welfare Technology companies a more safe, efficient, and easier access to China's healthcare market and to take 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 Nordic companies for the benefit of Chinese patients, and that way help develop new sales and export opportunities to China.

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

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

Concept

Concept - One-Stop Service

Although China is the world’s second largest market for both medical devices and medicines, many Nordic companies hold back from starting exports or own sales in China because of lack of market knowledge and entry barriers, and therefore perceive it as too difficult and risky. This cuts them off from a very 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 Nordic companies entering and operating in China.

NLSP is a one-stop service platform that helps 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 pull out during the process if they decide the Chinese market is not right for them.

With NLSP and our local partners in China, 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, market research, partner search, matchmaking, IPR protection, venture capital contacts, company set-up, registrations & approvals, and sales channels.

STEP-BY-STEP FLOW CHART

Hainan Boao Lecheng Intl. Medical Zone

Boao Lecheng International Medical Tourism Pilot Zone is a special medical zone in China that has been granted preferential policies and incentives that 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, and sell medical devices and medicines (Classes I, II, and III) for “urgent” need by the hospitals in Hainan Boao Lecheng that are not yet registered in China.

Criteria: 1) Cannot have been approved in China but with CE mark/FDA license/PMDA approval, 2) Innovative and cannot be replaced by an already approved predicate in China, and 3) Shall be used for a specific medical purpose at designated medical institution (i.e., sales agreement signed with hospital).

Moreover, it is the only place in China that allows the collection of Real-World Data (RWD) from the use of medical devices and medicines imported under the fast-track approval procedure that can supplement the application for the NMPA registration which will speed up the approval process for selling in the rest of Mainland China.

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, 17 hospitals/medical centers and 6 medical service centres are in operation with 8 new hospitals/medical centers opening in 2023, 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 2022, a total of 189,300 medical tourists were welcomed.

Hainan