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What has changed with the new guidelines? industry in the region. The zone has sought to
attract commercial investment and cooperation
The new guidelines on the import and use of with foreign institutions, including international
urgently needed medical devices in China contain hospitals, testing laboratories, medical colleges,
36 articles divided into six sections, expanding on and tourism institutions, to attract both domestic
the original document’s 27 articles. and international patients.

These guidelines outline the roles and To achieve this goal, the Beijing government
responsibilities of various entities, such has implemented various preferential policies
as provincial health and drug regulatory to upgrade the medical techniques, devices,
departments, medical institutions, and and drugs available at the Pilot Zone and meet
pharmaceutical enterprises. international standards by 2025.

Provincial health and drug regulatory departments As the only “special medical zone” in China that
must manage the importation, circulation, and use allows foreign participation in the medical field,
of these devices, assess associated risks, prevent the Pilot Zone has attracted high-end medical
illicit drug flow, and ensure proper control of drugs tourist services and cutting-edge medical research
with special management requirements. Medical outcomes, creating an industrial cluster of
institutions designated to use these devices are international medical services.
responsible for their proper use and disposal,
while pharmaceutical enterprises must follow Over 20 medical institutions have already opened
relevant regulations for purchasing, storing, and here, and 10 more specializing in fields like cancer
distributing these devices. prevention and treatment, cosmetic medicine,
anti-aging, health management, and rehabilitation
If a patient is harmed due to the use of an urgently are set to join.
needed imported medical device and drugs, the
designated medical institution must accept liability The new regulations on urgently needed drugs
and provide appropriate compensation. and medical devices are just the latest effort
The guidelines also recommend that designated to enhance Hainan’s healthcare industry. The
medical institutions purchase medical commercial establishment of the Hainan Free Trade Zone (FTZ)
insurance to protect against unforeseen events. is expected to further boost the medical tourism
Failing to comply with these regulations will have zone project and leverage market opportunities
repercussions for medical institutions. created by the growing demand for medical
products and services.
Benefits for foreign medical device manufacturers
Opportunities for foreign investors in Hainan’s
The new regulations offer a range of benefits for healthcare
overseas manufacturers.
Hainan’s success in establishing itself as a pilot
First, it provides them with access to the world’s FTZ presents exciting opportunities for foreign
largest market for medical products, estimated to investors in the healthcare sector. With significant
reach US$300 billion by 2025. By participating in investments made towards developing the
the program, overseas manufacturers can expand healthcare industry in the region, Hainan is on
their business and increase their revenue by track to becoming a world-class medical tourism
providing high-quality and in-demand products to destination and medical technology innovation
Chinese consumers. center by 2030.

Additionally, the program provides an Foreign investors can leverage the favorable tax
opportunity for overseas manufacturers to policies, incentives, and advantages available in
establish partnerships and collaborations with Hainan to invest in various healthcare sectors,
Chinese companies, further enhancing their such as international hospitals, third-party
competitiveness and market reach. testing institutions and laboratories, medical
colleges, pension insurance companies, and
The Hainan Medical Pilot Zone medical tourism institutions. By doing so, they can
capitalize on the increased demand for medical
The Chinese government launched the Hainan products and services and contribute to the
Boao Lecheng International Medical Tourism growth of the healthcare industry in the region.
Pilot Zone in 2018 to develop the healthcare

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