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“BoAo Hope City”, Unique Area for entering China medical device market without NMPA approval

Hainan Province, located in the very south of China, is the only tropical island province of China, famous for her charming coastal scenery & healthy living environment. The region is under construction towards a pilot free-trade-zone, gradually realizing the free flow of people, goods and capitals across borders. It is aiming to be the region with the most preferential policies and the highest degree of openness in China. If you focus on the preferential policies of medical device industry, you’ll find out that the BMTPZ (Hainan BoAo Lecheng International Medical Tourism Pilot Zone) , also called “BoAo Hope City” which we introduced in our earlier 2018 April and May blogs, will be your favorite. Key message here is that the clinically urgently needed medical devices, in so far, no product of the same specifications has been approved in China, can be easily imported and used in the designated medical institutions of the Hope city, if special approval is granted by the People's Government of Hainan Province.

Last Month, I visited BoAo as a member of Dutch delegation organized by the Guangzhou Consulate General, and had face to face meetings with key stakeholders, including local authorities, hospitals as well as Dutch manufacturers, and China key distributors. I have been amazed to see the big progress that has been made during the past 2 years. Let’s have a look:

  1. Over 100 Franchise Use Approvals have been granted to innovative medicines & devices, covering mainly cardiovascular, ophthalmology, dermatology, plastic surgery, oncology and infectious diseases; you can easily see those famous brands and products if you visit their “Ever Lasting International Innovation Medicine Cloud Exhibition” onsite, or online with VR technology.
  2. Efficiency of the authority reviews has been greatly improved. Upon setting the objective of reduce franchise use approval lead time from 27 working days to 3 working days, the current lead time takes 7 days. Fastest record so far is the Qinlock (Ripretinib), that was used by a Chinese patient only 24 hours after it received US FDA approval.
  3. Traceability management platform has been established and put into use, embedding the subsystems of franchise medical device application and approval as well as the adverse events monitoring.
  4. The Real World Evidence Research and Innovation Center has been established, initiated by Hainan MPA, Hope City and Huaxi Hospital. For example, Allergan’s product “XEN Glaucoma Treatment System” took the big advantage of obtaining NMPA approval within half a year by using the RWE data generated from the Hope City.
  5. An Integrated Insurance Service Platform has been established, and a trailblazing medical insurance policy that will cover foreign medicines yet to be approved domestically has been brought into effect.
  6. The non-profit organization, independent Patient Service Center, has been established.
  7. Both Enterprises and talents will enjoy the low tax rates policies in place.
  8. More Convenient travels: the 30 days new visa-free entry policy for Hainan covering 59 countries has been released in 2018. Both the BoAo airport and the BoAo railway station have been expanded in recent years.

With the great initiative and the full support from Central government, followed by effective implementations by the local government to establish the international platform, we’ve already seen some big differences, and we believe the Hope City will definitely bring hopes to more Chinese patients.  There are lots of the preferential policies implemented and more to be released in Hainan. We’ll keep watching the progress in Hope City and share with our clients the news as we did before. If you’re interested to know the details of some of the subjects, please do not hesitate to contact us.

Qserve can help you obtain regulatory approval for your medical device or In Vitro Diagnostics (IVD) in China. Our experts work directly with the China Health Authority, coordinating the submission of regulatory files and answering the Health Authorities feedback.

Veröffentlicht am:: November 24, 2020
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