NMPA Has Approved 163 Medical Device Products In June
2021-07-16
In June 2021, NMPA has approved a total of 163 medical devices. Among them, 110 of them are domestic class III medical devices, 28 of them are imported class III medical devices, 23 of them are imported class II medical devices, and 2 of them are medical devices from Taiwan of China.
Recovering quickly from the COVID-19 pandemic, China enjoys a good economic growth environment in the whole world. Since china encourages localization, more foreign manufacturers are seeking to establish facilities in China to localize their products. Regarding this, IMD can assist manufacturers in China entry, including facilities establishment, QMS compliance and local manufacturing.
In addition, two plastic surgery products are approved in June, and one of them is sodium hyaluronate product. Medical cosmetology is a large market in China with only several foreign manufacturers entering into this field. Normally conducting clinical trials is a traditional route to get approved in China. However, a fast track in Hainan, China may help overseas manufacturers to accelerate their registration process. In December 2019, Allergan’s Juvéderm ® Volux started urgent use in Hainan to collect RWD for China registration, and in April, 2021, it has been approved by NMPA for sales in whole China.
Major benefits of Hainan Medical Tourism Pilot Zone are as following:
Expanded scope of overseas imported medical devices allowed to enter the Pilot Zone;
Imported and inventoried products in Hainan are considered duty-free;
Greater access to urgently needed medical devices entering Hainan via the emergency review pathways, and devices can be stored in bonded warehouses in Pilot Zones before approval is obtained;
More leeway given to enterprises to collect and apply real-world clinical data for medical devices, to expedite approval processes and shorten time of marketing.
The urgent use approved products by Hainan can be promoted outside of Hainan throughout China;
Patients can come from anywhere in China. However, treatments need to be done in Hainan, but follow-up can be done outside of Hainan. Generating revenue immediately while collecting Real-World data (RWD);
Products can be sold directly to hospitals from overseas manufacturers.
Contact us for bringing your products to the pilot zone.
