top of page
LCAerial6.jpg

Nordic Life Science Platform 

FAST-TRACK CHINA ENTRY

- Medical  Devices, Medicines, and
Rehabilitation Equipment

Webinar: Exploring China’s Healthcare Market – Trends, Opportunities, and Challenges
Tuesday, 28 May 2024 from 09.00 – 10.30 (CET) / 15.00 – 16.30 (CST, China)
- Organized by DI Life Science and Nordic Life Science Partners ApS with the support of the
Danish Life Science Cluster, DCBF, Coloplast and Novo Holdings (Click here for Online Registration)

China Market Access via Fast-track Approvals and Real-World Data Studies for CE/FDA/PMDA approved Medical Devices, Medicines, and Rehabilitation Equipment 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 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

Our mission is to match the demand for innovative medical devices, medicines, and rehabilitation equipment 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 access and develop new sales 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 the market opportunities in China further, the Nordic Life Science Partners ApS has established a Partnership with the Danish Life Science Cluster, and Innovation Center Denmark in Shanghai.

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.

20240416_094715.jpg
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 helathcare/hospital market.

With NLSP and our local partners, our experienced team will assist Nordic/European life science 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, product evaluation, matchmaking, fast-track approval, CRO partnering for RWD study, market research, partner search, company set-up, product registrations, and sales & distribution channels.

STEP-BY-STEP FLOW CHART

Step-by-Step Flow Chart (22 January 2024).png
HBL Aerial1.jpg

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, 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, sell, and import "Innovative" medical devices, medicines, and rehabilitation equipment in need by the hospitals in Hainan Boao Lecheng that are not registered in Mainland China. 

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.

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

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.

Hainan

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.

China-Hainan Maps, No background Colors.png
5.jpg
Our Team

Team - Expert Advice and Support

Our expert team has many years of operational experience from doing business in China, and welcome Nordic/European life science companies to enter the Chinese healthcare market and to take advantage of the preferential policies and opportunities at Hainan Boao Lecheng International Medical Zone.

2, Square_edited.jpg
  • Noam David Stern

Noam David Stern,
Co-founder & Owner,
China

_RBL1465_edited_edited.jpg
  • Peter Oelbye

Peter Ølbye,
Co-founder & Adviser, Denmark

WeChat Image_20171022155913_edited_edite
  • Daisy Du

Daisy Du,
Legal Counsel,
China

Sharon_edited.jpg
  • Sharon Xu

Sharon Xu,
Medical Project Manager, Germany & China

Marcus
  • Marcus Woldsen

Marcus Woldsen,
BD & Project Manager, Denmark

Frederik
  • Frederik Krebs

Frederik Krebs,
BD & Project Manager, Denmark

Partners

Partnership

NLSP11.png
DLSC logo.jpg
ICDK (color background).jpg
Contact

Contact

Nordic Office

Lyngby Hovedgade 17, 2. th,
2800 Kgs. Lyngby, Denmark

Mobile: +45 2530 8027

info@nlsp.dk

​China Office

Room 2003, Level 20, 989 Changle Road,

Xuhui, Shanghai 200031, China

Mobile: +86 136 1169 1358

info@nlsp.dk

bottom of page