Hainan Pilot Zone (Boao Lecheng)

Hainan is a large island off China’s south coast and the most southern province in China, known as China’s within-country beach resort destination or “China’s Hawaii”. In April 2018, President Xi Jinping announced at the province’s 30th anniversary that the entire island would be transformed into a Free Trade Zone.

To cater for wealthy Chinese who might otherwise go abroad for their medical care, the Chinese government had also encouraged development of a medical tourism zone in order to benefit from a business model of having medical treatment at a top level in a top-level holiday region. This requires access to the most innovative medical technology.

The Boao Lecheng International Medical Tourism Pilot Zone (the “Pilot Zone”), which now sits within the (province-wide) Hainan Free Trade Zone, was approved by the State Council in 2013 and accommodates a number of Chinese and foreign cooperative medical institutions within the roughly 20km² area. Importantly, medical devices and IVDs not otherwise registered with the NMPA can be imported into the Pilot Zone with the approval of the Hainan provincial MPA. (As confirmed by the “Decision of the State Council on Suspending the Implementation of the ‘Regulations on the Supervision and Administration of Medical Devices’ in the Boao Lecheng International Medical Tourism Pilot Zone, Hainan Province” issued 2 April 2018.)

Once a product is approved for use within the Pilot Zone, the product can, with the consent of the Hainan MPA and the NMPA, collect real-world data on Chinese nationals which can then be used as supplementary evidence for an NMPA registration that would enable China-wide sales. Hospitals within the Pilot Zone are closely involved in the process, and would need to submit the import application to Hainan MPA. In parallel, the manufacturer applies to NMPA for real-world data approvals.

There are two focus areas for NMPA with respect to such applications: the product should be urgently needed for clinical use and there should be no products of the same variety in China. However, further clarity is still awaited from the authorities because these focus areas are not clearly defined.

Since the Pilot Zone has commenced, fewer than one hundred urgently-needed imported medical devices have been accepted into the Pilot Zone by the Hainan MPA as at the time of writing. However, global interest is high. Only 1 device, a glaucoma drainage tube approved by the NMPA at the end of March 2020, has obtained NMPA approval for sale throughout China. The real-world data was obtained within the Hainan Pilot Zone and supported clinical data obtained outside of China.

Therefore, real-world data collection in Hainan Pilot Zone is an interesting development in a company’s clinical strategies. For those interested in staged entry into the Mainland market and with clinical data elsewhere but that may need supplementation with use on Chinese nationals, it is quite exciting. Contact us for the latest or to learn more.

By Hamish King. Contact Hamish or Cisema for our standard checking offer for your product for Boao Lecheng Pilot Zone.