The Pilot Zone at a Glance

The Hainan Boao Lecheng International Medical Tourism Pilot Zone (the “Pilot Zone”) was established with the approval of the State Council on February 28, 2013. Granted by preferential policies, the Pilot Zone develops the related industries of international medical tourism such as licensed medical treatment, health management, care rehabilitation, medical cosmetology, and anti-aging. 

The zone is the only one in China that enjoys nine preferential policies, such as special permission to import medical products. Those policies allow medical institutions in the Pilot Zone to import and use drugs and medical equipment from overseas that are in urgent clinical need but not yet approved by the National Medical Product Administration (NMPA) in China. The Pilot Zone has introduced over 100 innovative foreign medical devices and drugs. 

Favorable Policies in the Pilot Zone to Boost Medical Aesthetics

Medical aesthetics is one of the characteristic domains the Pilot Zone. In 2021, 20 medical institutions are expected to enter the Pilot Zone, and among them are some specialized medical aesthetics institutions.

Liu Zhefeng, deputy head of the zone administration, said “The reason we introduced a medical aesthetics product into the pilot zone is that we see constantly surging need. Every year, 600,000 Chinese go abroad to see doctors, among whom 20 percent are seeking medical aesthetic services. We hope that Chinese residents can enjoy international-standard medical products without going abroad.”

According to a recently released policy document by the Ministry of Commerce in April 2021:

• Medical aesthetics products approved or listed in the United States, the European Union, Japan, and other countries or regions can be used in the Hainan Pilot Zone. 
• Hainan can formulate incentive measures to encourage and assist in the NMPA registration of medical products (including drugs, medical devices, and cosmetics) needed to develop the medical aesthetics industry in the Pilot Zone.
• Support foreign high-level medical aesthetic doctors to practice medicine in Hainan for a short time per laws and regulations.
• Promote the development of the medical aesthetics & tourism industry and support international and professional medical aesthetics exhibitions, summits, and forums. 
• Standardize the approval and supervision of medical aesthetics hospitals and institutions.

The First Medical Aesthetics Launched in the Pilot Zone

Allergan’s Juvéderm® VOLUX, the hyaluronic acid injectable gel, is the first aesthetic product approved by the Pilot Zone. Since the product was launched in July 2020, 100 patients with mandibular retraction have completed injection treatment, generating a considerable number of clinical injection cases and real-world data. These results will be used as evidence for clinical research and decision-making to help the application of real-world data in the registration and approval of medical aesthetics products in China. 

Apart from Allergan Aesthetics, other healthcare firms are also mapping their medical aesthetics layouts in the Pilot Zone.

In 2016, Shanghai-based Beauty Firm launched the construction of a medical anti-aging center, a report by BJNEWS said. With a total investment of 190 million yuan ($26.9 million), it plans to build the center in six years and integrate body inspection, diagnosis, treatment, and nursing.

In 2019, Beijing-based Yiling Hospital Management Group launched a breast beauty center in Boao Lecheng to tap the medical aesthetics sector in the pilot zone, BJNEWS reported.

Bradyknows Medical’s Initiatives in Pilot Zone

• We have established a subsidiary in Hainan and build up a team to support medical aesthetics products enter Hainan.
• We maintain a long-term relationship with the local government of the Hainan Pilot Zone since 2019
• We have helped several clients’ multiple products to successfully join the Fast-Track Pilot Program Real World Evidence Program in Hainan. Our efforts in Hainan will support and accelerate the national NMPA approval for our clients.