Hainan Free Trade Port Construction White Paper Released! Promoting Innovative Medical Device Imports

In the field of industrial development, the Ministry of Culture and Tourism, the National Health Commission, and the National Medical Products Administration actively promoted the construction of the Boao Lecheng International Medical Tourism Pilot Zone.

In terms of developing an outward-oriented economy, a comprehensive pilot program was launched to expand the opening up of the service sector, focusing on key areas such as tourism, transportation, and medical health, gradually relaxing entry restrictions, promoting the elimination of administrative barriers, and improving the regulatory system.

In terms of institutional construction, documents such as the "Reform Plan for Integrated Institutional Innovation in the Boao Lecheng International Medical Tourism Pilot Zone" were issued to promote integrated institutional innovation in key areas.

Through continuous exploration and practice, Hainan Free Trade Zone has made significant breakthroughs in innovative medical device imports.The Boao Lecheng International Medical Tourism Pilot Zone has achieved a breakthrough of 135 cases in the first use of imported special-approved pharmaceuticals and medical devices, becoming an important channel for the latest international innovative pharmaceuticals and medical devices to Enter the Chinese market.At the same time, it has driven the continuous expansion of modern service industries such as medical care and health care,In 2020, the number of medical tourists received by pilot zone medical institutions increased by 11% year-on-year,In the first quarter of 2021, the Lecheng Pilot Zone received 25,392 medical tourists, a year-on-year increase of 932.20%.The contribution rate of the service sector to economic growth reached 95.8%.

To consolidate and expand the achievements of the pilot zone's medical device industry development, Hainan Province continuously improves and perfects local regulations and strengthens trade risk prevention and control. By formulating the Hainan Free Trade Port Boao Lecheng International Medical Tourism Pilot Zone Regulations and establishing a medical products supervision and administration bureau to manage medical services and the safety of pharmaceuticals and medical devices in the pilot zone, a good environment has been created for the development of new medical technologies, products, business formats, and models in the pilot zone.

On June 3, the Boao Lecheng International Medical Tourism Pilot Zone and 11 other key parks in the Hainan Free Trade Port held simultaneous unveiling ceremonies.

On June 7, 12 international pharmaceutical and medical device manufacturers established in-depth cooperation relationships with the Boao Lecheng International Medical Tourism Pilot Zone of the Hainan Free Trade Port through simultaneous online and offline signing ceremonies,At least 50 more ophthalmology-specific pharmaceuticals and medical devices will be introduced based on the existing foundation, supporting the construction of a super ophthalmology center in the Lecheng Pilot Zone.

On June 9, the number of cases of imported special-approved pharmaceuticals and medical devices in the Boao Lecheng International Medical Tourism Pilot Zone of the Hainan Free Trade Port had exceeded 100, with 100 types of new anti-tumor drugs and rare disease drugs available.

On June 15-16, the 20th meeting of the Sixth Standing Committee of the Hainan Provincial People's Congress passed the "Hainan Free Trade Port Boao Lecheng International Medical Tourism Pilot Zone Regulations".

On September 1, the General Office of the Hainan Provincial Government issued the "Reform Plan for Integrated Institutional Innovation in the Hainan Free Trade Port Boao Lecheng International Medical Tourism Pilot Zone".

On November 27, the National Medical Products Administration’s Drug and Medical Device Regulatory Science Research Base was unveiled at the 2020 Clinical Real-World Data Application Pilot Work Leading Group (Enlarged) Meeting.

On January 20, the Hainan International Arbitration Institute’s International Medical Dispute Mediation/Arbitration Center was unveiled in Boao Lecheng.

On April 1, the 31st meeting of the Hainan Provincial Committee for Deepening Reform and the 30th meeting of the Free Trade Zone (Port) Working Committee were held, at which the "Implementation Opinions on Deepening Medical Security System Reform (Draft for Review)" was reviewed and approved.

On April 15, the Hainan Provincial Party Committee and the Provincial Government issued the "Implementation Opinions on Deepening Medical Security System Reform".

The introduction of a series of relevant policies and the establishment of major institutions and projects have created a superior development environment for the upgrading and innovation of the pilot zone’s medical device industry. The Hainan Free Trade Zone has become an important window for accelerating the realization of import substitution of medical devices and a typical example of promoting the development of the medical and health care industry.