The official clarified the punishment standard for medical device manufacturers to refuse to recall defective products.

　　BEIJING, Feb. 8 (Xinhua) According to the website of the Food and Drug Administration, the website of the Food and Drug Administration today announced the Measures for the Administration of Medical Device Recall. The "Measures" stipulate that medical device manufacturers refuse to recall medical devices, and if the circumstances are serious, they will be ordered to stop production and business.

　　On June 1, 2014, the newly revised Regulations on the Supervision and Administration of Medical Devices was promulgated and implemented, which put forward new requirements for the recall of medical devices. China food and drug administration revised the original Administrative Measures for Medical Device Recall (Trial) to form the Administrative Measures for Medical Device Recall, which came into effect on May 1, 2017.

　　The defective medical device products mentioned in the Measures include:

　　(1) Products with unreasonable risks that may endanger human health and life safety under normal use;

　　(two) products that do not meet the mandatory standards and the technical requirements of registered or filed products;

　　(three) products that do not meet the relevant provisions of the quality management of medical device production and operation, which may lead to unreasonable risks;

　　(4) Other products that need to be recalled.

　　The "Measures" stipulate that medical device recalls can be divided into active recalls and ordered recalls according to the different starting conditions of medical device recalls.

　　According to the severity of medical device defects, medical device recalls are divided into:

　　(1) First-class recall: the use of the medical device may or has caused serious health hazards;

　　(2) Secondary recall: the use of the medical device may or has caused temporary or reversible health hazards;

　　(3) Three-level recall: it is less likely that the medical device will cause harm, but it still needs to be recalled.

　　The Measures stipulate that if a medical device manufacturer refuses to recall medical devices in violation of Article 24 of the Measures, the food and drug supervision and administration department of the people’s government at or above the county level shall order it to make corrections and confiscate the medical devices illegally produced, operated or used in accordance with Article 66 of the Regulations on the Supervision and Administration of Medical Devices; If the value of medical devices illegally produced, operated or used is less than 10,000 yuan, a fine ranging from 20,000 yuan to 50,000 yuan shall be imposed; If the value of the goods is more than 10,000 yuan, a fine of more than 5 times and less than 10 times the value of the goods shall be imposed; If the circumstances are serious, it shall be ordered to stop production and business until the original issuing department revokes the registration certificate, production license and business license of medical devices.

　　At the same time, the "Measures" stipulate that medical device operating enterprises and users who refuse to cooperate with the investigation of medical device defects and refuse to assist medical device manufacturers in recalling medical devices shall be given a warning and ordered to make corrections within a time limit; Those who refuse to make corrections within the time limit shall be fined up to 30,000 yuan.