Previously, the foreign medical device shall first get its registration approval from the NMPA main center prior to its importation through other regions of China. However, NMPA has recently given power to China’s two major cities coastal cities – Chongqing and Fujian, in issuing approval to foreign medical devices entering the country. In 2018, NMPA Hainan branch was authorized to approve the urgent clinical needed medical device. Right now, NMPA opens more registration channels.
In accordance with the "Notice of the State Council on Supporting the Measures for Deepening Reform and Innovation in the Pilot Free Trade Zone" ([2018] Measure No. 38), it was announced that Chongqing and Fujian Drug Administration is now authorized to approve the registration application for some foreign medical device. Manufacturers meeting the requirements set by these ports would thereby have a more convenient import channel. The salient points given in the said noticed are hereby enumerated:
1. Since January 18, Chongqing Drug Administration was granted approval for the foreign biological products entering China market. Biological products approved by Chongqing also needs to be imported via Chongqing customs and undergo product inspection in Chongqing Testing Institute. In cases where Chongqing Testing Institute does not have the ability to test some particular biological products, the Test Institute may entrust the China Testing Institute to do the inspection.
2. Since January 17, the Fujian Drug Administration has been granted the power to issue registration approval of foreign Class I medical devices produced in Taiwan and imported through Pingtan Port.
Reference:
The official press for opening the approval power of Fujian Drug Administration