Notice on the public solicitation of opinions on the guidelines for the technical review of the second-class medical device registration in 2020

All relevant units:

According to the relevant requirements of the National Medical Products Administration's 2020 Medical Device Registration Guidelines Project Plan, our center has organized and compiled 22 Class II guidelines (Annex 1) including the "Technical Guidelines for the Registration of Net Nebulizers". A draft for soliciting opinions has been formed, and comments will be publicly solicited on the Internet from now on. If you have any comments and suggestions, please fill in the feedback form (Annex 2) and send it back to the corresponding contact person (Annex 3) before April 17, 2021.

　　Annex: 1. 22 second-class guidelines including "Technical Guidelines for Registration of Net-type Atomizers" (download)

　　2. Feedback form (download)

　　3. Contact (download)

State Drug Administration

Medical Device Technology Review Center

March 17, 2021

Attachment

1. 22 second-class guiding principles including "Technical Guidelines for the Registration of Net Atomizers" (click on the picture to view)