03/18/2021 State Council of PRC

According to State Council of PRC, “Regulations on Supervision and Administration of Medical Device” has been revised and adopted at the 119th executive meeting of the State Council on December 21st, 2020.  It is hereby announced and will be implemented on June 1st, 2021.

While mostly remains the same comparing to 2017, the newer version had revisions including:

“Chapter 3 Article 39: Medical devices should have instructions and labels. The contents of the instructions and labels shall be consistent with the relevant contents registered or filed to ensure authenticity and accuracy.  The instructions and labels of medical devices shall indicate the following items:”

Remove:

• The name and domicile of the manufacturer, address of production and contact information.
• Serial number of product technical requirements.

Add:

• The name, address and contact information of the medical device registrant, recorder, and entrusted manufacturer.

Source:

http://www.gov.cn/zhengce/content/2021-03/18/content_5593739.htm