Announcement of Matters Concerning the Production of Imported Medical Devices Within the Territory of China

On September 26, 2020, CMDE released an announcement of matters concerning the production of imported medical devices within the territory of China. The relevant matters applicable to the announcement are as follows: the registration applicants of imported medical devices produce their Class II or III products, which have obtained the overseas NMPA certificate, in China through the foreign-invested enterprises established within the territory of China. This will optimize the content of the registration documents and avoid the duplicate submission.

Link: https://www.nmpa.gov.cn/xxgk/ggtg/qtggtg/20200925152407171.html

https://www.nmpa.gov.cn/xxgk/zhcjd/zhcjdylqx/20200925152939121.html

https://www.nmpa.gov.cn/yaowen/ypjgyw/20200925152708196.html