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China Free-Trade Zone Opens Fast Access To Foreign Innovative Therapies

But costs, location may be issues

 
• By Brian Yang

A free-trade zone in China’s southernmost island province of Hainan aims to spur local health care industry, which has been among the hardest hit sectors in the coronavirus outbreak.

Forbidden city, Beijing
CHINA OPENS DOORS TO NEW DRUGS, DEVICES IN HAINAN FREE TRADE ZONE

Before the pandemic, Hainan was touted as the “Hawaii of the East” and lured tourists from both China and around the world to its beach resorts and oceanfront villas. But the global outbreak has meant no returning visitors and has put the local economy into free-fall. To revitalize the island, the youngest of China’s 30 provinces, local authorities on 9 June announced a pilot project to allow the use of hundreds of innovative new drugs and medical devices inside one of its special trade regions, Lecheng.

Even to many locals, the name is unheard of and the free-trade zone started taking shape only in 2019, when China’s state planner, the National Development and Reform Commission, along with the National Medical Products Administration and National Health

More from Asia

Medical Devices Not The Focus Of FDA’s Plans To Step Up Foreign Inspections, Expert Says

 
• By Brian Bossetta

The US FDA recently announced plans to carry out more unannounced inspections of foreign facilities. But those inspections will primarily target drug producers, with less attention and resources allocated to those making devices.

Consumer Healthtech Investment Totaled $4.5BN In 2024, But Bar Is High Amid Economic Uncertainty

 
• By Marion Webb

Global investment in consumer healthtech increased by 9% year-over-year in 2024, totaling $4.5bn, with significant interest in mental health solutions, according to Galen Growth. While the first quarter of 2025 saw raised confidence and investments, the Trump administration’s new tariffs and sweeping changes to healthcare have introduced new uncertainties.

Don’t Sleep On Inspections: Experts Warn FDA Maintains Enforcement Resources

 
• By Brian Bossetta

Manufacturers of medical products would be foolish to think that recent upheavals at the US FDA will result in a lack of inspections in the coming years. A panel of experts discussed the current state of inspections during a webinar hosted by the Food and Drug Law Institute.

South Korea Adds Digital Health Rules To Already Complicated Regulatory Landscape

 
• By Elizabeth Orr

A New South Korean law, the Digital Medical Products Act, enhances regulation for digital health products. Medical devices in the country are categorized both by risk and by similarity to already authorized devices. The approval process may stretch to 515 days for new manufacturers.

More from Geography

Health Secretary Defends Spending Cuts During Senate Hearing On HHS Budget

 
• By Elizabeth Orr

Health and Human Services Secretary Robert F. Kennedy Jr. emphasized administrative cost reductions and defended budget decisions during a Senate hearing on HHS funding. Some senators, however, expressed concerns over the impacts spending cuts had on essential health programs.

Tariffs Threaten Medtech Innovation And US Position As World Leader, Whitaker Tells Lawmakers

 
• By Brian Bossetta

During his testimony before US senators on the impact of tariffs on critical supply chains, AdvaMed’s Scott Whitaker said the Trump tariffs could jeopardize America’s preeminence in medtech. Other industry experts echoed similar concerns.

Califf Warns Progress May Be In Danger Due To ‘Decimated’ FDA Staff

 
• By Barnaby Pickering

In Vivo spoke to the previous commissioner of the US FDA about recent ongoings at the agency, and where he believes policy should be directed for patient and industry benefit.