On 18.05.2020, the Hainan MPA (Medical Products Administration) announced a total of 47 overseas applications received for the second round of medical devices to enter the Hainan Boao Lecheng International Medical Tourism Pilot Zone (Pilot Zone), an increase of 292% compared to the previous round.
In addition, the NMPA also recently held a webinar with Allergan, the US global pharmaceutical company that was recently acquired by AbbVie Inc, about the approval of Allergan’s product via the Hainan Pilot Zone. We have reported on that separately here.
Since the US firm Allergan’s glaucoma drainage tube was approved by the NMPA on 26.03.2020 to become the first imported medical device utilizing real-world data to register in China, more foreign MedTech manufacturers have been showing interest and actively participating in the Hainan Pilot Zone.
During the registration process of Allergan’s glaucoma drainage tube, the NMPA also utilized the real-world data collected in Hainan’s Pilot Zone to evaluate ethnic diversity among patients.
As of 09.05.2020, 42 batches of overseas medical devices were approved for import to urgently support the clinical treatment of 284 patients in medical institutions located in the Hainan Pilot Zone.
By Jacky Li. Contact Cisema to learn more.
