The State Food and Drug Administration issued a national medical device quality announcement on the 5th. In the recent quality supervision and inspection of six varieties of 463 batches of medical devices, 440 batches of products were all qualified. Among the medical device products that were found to be out of compliance with the standard, including a number of Chinese medicine Medical Equipment.
The announcement pointed out that the 11 batches of medical equipment products of the 2 varieties that were tested were not in compliance with the standard, including 3 batches of disposable infusion set gravity infusion type (with needle) and 8 sets of Chinese medicine diagnosis and treatment electrical equipment. The items to be tested are medical equipment products that do not meet the standards, such as labeling labels, instructions, etc., involving 2 varieties and 16 batches (sets), including 11 sets of Chinese medicine medical equipment, and one-time use infusion unit gravity infusion type (with needle) 5 Batch. The reporter learned that there are 4 batches (sets) of products that have been tested and those that have been tested are not in compliance with the standards.
For the products found in the above-mentioned sampling tests that do not meet the standards, the Food and Drug Administration has required the food and drug supervision departments at the place where the enterprises are located to investigate and deal with relevant enterprises in accordance with relevant regulations.
23 batches of medical devices that do not meet the standard Chinese medical treatment also include
According to the announcement, the relevant medical device manufacturers should conduct risk assessments for products that do not meet the standards and products that do not meet the standards. The recall level is determined according to the severity of the medical device defects, and the company actively recalls and publicly recalls the information. The food and drug supervision department at the location of the enterprise shall supervise the recall of the enterprise and shall not recall the recall of the enterprise; if it is found that the medical device product does not meet the standards and cause harm to the human body or there is evidence to prove that it may endanger human health, it may suspend production, Emergency control measures such as import, operation and use.
According to reports, the relevant provincial food and drug supervision and administration departments will urge enterprises to ascertain the reasons as soon as possible, formulate rectification measures and rectify them in time, and the relevant disposal situation will be announced to the public before August 30.
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