The Hainan MPA announced the implementation of a new regulation to support the urgent clinical needs of medical device imports in Hainan’s Boao Lecheng International Medical Tourism Pilot Zone.
This zone is also known as the Boao Hope City. The prerequisites for importing medical devices urgently needed for clinical treatment prior to NMPA approval are as follows:
- The product should be approved in US, Europe and/or Japan
- There are currently no other devices, serving the same purpose, which could be sourced from the Chinese market already
- The medical device can effectively provide clinical treatment or prevention to the patient with a life-threatening disease
- Significant clinical advantages of the device can be demonstrated
As a free trade port, Hainan in South China is aiming for the highest level of global openness. Many advanced medical devices that haven’t been introduced elsewhere in China are available here at Boao Lecheng International Medical Tourism Pilot Zone. Additionally, Boao Hope City is actively promoting reforms to medical and healthcare services, with the time needed to approve licensed drugs now cut to a minimum of a few days.
If you’re a medical device company treating life-threatening disease, Boao Hope City will be your ideal choice to enter the Chinese market. Entering the market this way, will lay a solid foundation for the local clinical studies which are needed later on for the NMPA approval. You’ll also be able to offer your solution to patients who urgently need it.