On August 11, 2022, NMPA issued Announcement on filing class I medical devices to release a serial of documents to regulate the filing requirements on class I medical device.

The document specifies

·   medical device manufacturer filing responsibilities and responsible agencies

·   filing requirements and processes

·   reporting and information sharing

For the original link of the document, please visit:

https://www.nmpa.gov.cn/xxgk/ggtg/qtggtg/20220811172649189.html 

If you have any question or more information, please contact:

assistant@bestao-consulting.com

Additional information: China Medical Device Classes & Categories

Class I

Low-risk medical devices whose safety and effectiveness are ensured through routine administration.

Class II

Mid-risk medical devices that require further control in order to ensure their safety and effectiveness.

Class III

High-risk medical devices that are implanted into the human body, used to support or sustain life, or pose potential risk to the human body and thus must be strictly controlled in respect to safety and effectiveness