China Quality News Network News Recently, the Chongqing Municipal Drug Administration issued a 2020 Chongqing Municipal Medical Device Supervision and Sampling Inspection That Does Not Meet the Standards Product Quality Announcement. According to the announcement, the Chongqing Municipal Drug Administration has completed the 2020 municipal medical device supervision and sampling work, and a total of 45 batches (units) of products do not meet the standard regulations.
Among them, 1 batch of blood purification is unqualified, and 1 batch is Chongqing Shanwaishan Blood Purification Technology Co., Ltd., and the marking involving the controller and instrument does not meet the standard regulations. The specific information is as follows:
serial number
Indicate the product name
Units being spot checked
Label the production unit
Specification/model
Manufacturing date/lot number/factory number
Sampling units
Inspection units
Non-conforming items
remark
1
Hemodialysis machine
Chongqing Shanwaishan Blood Purification Technology Co., Ltd
SWS-6000
2020 06/6200500830
Chongqing Municipal Drug Administration Inspection Bureau Inspection Bureau
Chongqing Medical Device Quality Inspection Center
6.3 Marking of controllers and meters
*
Note: The label marked "*" in the remarks column does not comply with the regulations.