Device defects refer to unreasonable risks that may endanger human health and life safety during normal use of medical devices during clinical trials, such as labeling errors, quality problems, malfunctions, etc.
Labeling errors: Labeling errors caused by production operators, labels falling off during transportation, etc. have nothing to do with the performance of the product and can lead to usage errors.
Quality problems: due to damaged, loose accessories, power outages, unstable connections, lost storage, etc.
Based on the severity of medical device defects, medical device recalls are divided into:
(1) Level 1 recall: The use of the medical device may or has caused serious health hazards;
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(2) Level 2 recall: The use of the medical device may or has caused temporary or reversible health hazards;
(3) Level 3 recall: The use of the medical device has caused harm Less likely but still necessary to recall.
Medical device manufacturers should determine the recall level based on specific circumstances and scientifically design a recall plan and organize its implementation based on the recall level and the sales and use of medical devices.
Extended information
If a medical device manufacturer violates the provisions of Article 24 of the "Regulations" and refuses to recall medical devices, it shall be punished by The food and drug supervision and administration department of the people's government at or above the county level shall order corrections and confiscate medical devices that are illegally produced, operated or used.
If the value of the medical device illegally produced, operated or used is less than 10,000 yuan, a fine of not less than 20,000 yuan but not more than 50,000 yuan shall be imposed; if the value of the medical device exceeds 10,000 yuan, a fine of not less than 10,000 yuan shall be imposed. A fine of not less than 5 times but not more than 10 times the amount may be imposed; if the circumstances are serious, the company may be ordered to suspend production and business until the original issuing department revokes the medical device registration certificate, medical device production license, and medical device business license.
People's Daily Online - Interpretation丨About the "Medical Device Recall Management Measures", you should know these