According to the website of the Food and Drug Administration, the website of the Food and Drug Administration announced today the “Administrative Measures for Medical Device Recallâ€. The "Measures" stipulate that medical device manufacturers refuse to recall medical devices, and the circumstances will be ordered to suspend production and business. On June 1, 2014, the newly revised Regulations on the Supervision and Administration of Medical Devices was promulgated and implemented, and new requirements for medical device recalls were proposed. The State Food and Drug Administration has organized the revision of the original "Administrative Measures for Medical Device Recall (Trial)" to form the "Administrative Measures for Medical Device Recall", which will take effect on May 1, 2017. The medical device products that are described as defective in the Measures include: (1) Products with unreasonable risks that may endanger human health and life safety under normal use; (2) Products that do not meet the technical requirements of the mandatory standards, registered or filed products; (3) Products that do not meet the relevant regulations on the production and operation quality management of medical devices, which may lead to unreasonable risks; (4) Other products that need to be recalled. According to the Measures, according to the different starting conditions of medical device recalls, medical device recalls are divided into active recalls and ordered recalls. Data map. Shooting According to the severity of medical device defects, medical device recalls are divided into: (1) Level 1 recall: the use of the medical device may or may have caused serious health hazards; (2) Secondary recall: the use of the medical device may or may have caused temporary or reversible health hazards; (3) Three-level recall: The use of the medical device is less likely to cause harm but still needs to be recalled.
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CFDA expressly refuses to recall penalties for defective medical products