Medical devices are special commodities involving human health and life safety, so their quality and safety are very important. Once a medical device is defective or does not meet the standard, it may cause serious injury and harm to patients. In order to protect the rights and interests of patients and social public **** interests, China has adopted a series of regulatory measures, one of which is the medical device recall system. Medical device recall is a proactive management approach, that is, defective products or medical devices that may cause harm to the human body need to be recalled and disposed of. According to the "Regulations for the Supervision and Administration of Medical Devices", a medical device secondary recall means that if a listed medical device is defective or does not meet the standards, which may cause serious harm to the human body, the company needs to report to the supervisory authority and take the initiative to implement the recall measures within 15 working days. Generally speaking, medical device secondary recall is initiated by medical device manufacturers or importers. Enterprises are required to report recall information to the regulatory authority in a timely manner, and at the same time take effective measures, such as notifying users, removing the product from the shelves, repairing or replacing the product, etc., to ensure that the recall action is implemented. The regulatory authorities will monitor and assess the recall situation and penalize companies that do not fulfill their recall obligations.
How do medical device recalls affect consumers? Medical device recalls can have certain implications and risks for consumers. If a consumer uses a medical device that is defective or does not meet standards, it may pose a threat to his or her health and safety. Therefore, when purchasing and using medical devices, consumers should choose regular channels to purchase, pay attention to product brand and quality, and comply with the instructions for use.
The recall of medical devices is a management method to protect the rights of patients and the interests of the public ****. Medical device manufacturers or importers need to be found in the medical device defects or non-compliance with standards, may cause serious harm to the human body in a timely manner to the regulatory authorities to report and implement recall measures. At the same time, consumers should also pay attention to the brand and quality of the product, choose the regular channels to buy and use medical devices, in order to protect their own health and safety.
Legal basis:
"The Chinese people*** and the State supervision and management of medical devices regulations" Article 59 medical device manufacturers or importers of medical devices found to have been listed on the medical device is defective or does not meet the standards, may cause serious harm to the human body, should be timely to the State Council competent department of health report, and to take the necessary measures to recall.