Guangdong Becomes Second Province to Import Unapproved Medical Device

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2020-12-25

“The designated medical institutions in the region can use medical devices that are urgently needed for clinical use, and have been purchased and used by public hospitals in Hong Kong and Macao,

and have advanced clinical applications, which can be approved by the Guangdong Provincial Government”, according to joint announcement by eight central government agencies, including national NMPA, State Administration for Market Regulation, National Development and Reform Commission and five others, on November 25, 2020.

Real World Data and Hainan Policy

The first pilot area where unapproved devices can be used includes nine cities in Guangdong. Importation Devices Catalog is to be published. If your devices are used in Hong Kong and Macau, and you want to clinically use them in Guangdong, please contact us. We can consolidate your opinions and send to responsible parties.

Real World Data (RWD) program trialed in Guangdong could be expected. For RWD guideline, please contact us.

The announcement synchronizes with the development of Guangdong-Hong Kong-Macau Greater Bay Area, which houses over 70 million people.

The groundbreaking policy, after successfully trialed in Hainan, is to attract western device manufacturers, investors, and medical tourists into Guangdong. Previously, none of the major policies cross the NMPA bottom line – the only authorized state department to approve imported devices.

For urgent needed device policy and RWD program in Hainan, please contact us.

The announcement also concerns the incentive policies on drugs, Chinese medicines and Market Authorization Holder (MAH), etc.