Chapter 1 General Provisions Article 1 In order to strengthen the supervision and management of medical devices and protect human health and life safety, in accordance with the "Regulations on the Supervision and Administration of Medical Devices" and the "State Council's Regulations on Strengthening the Supervision and Administration of the Safety of Food and Other Products" Special Provisions" and formulate these measures. Article 2 These Measures shall apply to the recall and supervision and management of medical devices sold within the territory of the People’s Republic of China. Article 3 The term "medical device recall" as mentioned in these Measures refers to the measures taken by medical device manufacturers to warn, inspect, repair and relabel defective products of a certain category, model or batch that have been put on the market in accordance with prescribed procedures. , modifying and improving the instructions, software upgrades, replacements, withdrawals, destructions, etc. to eliminate defects. Article 4 The term "defects" as mentioned in these Measures refers to the unreasonable risks of medical devices that may endanger human health and life safety under normal use. Article 5 Medical device manufacturers are the main body in controlling and eliminating product defects and shall be responsible for the safety of the products they produce. Article 6 Medical device manufacturers shall establish and improve the medical device recall system in accordance with the provisions of these Measures, collect relevant information on medical device safety, investigate and evaluate potentially defective medical devices, and recall defective medical devices in a timely manner.
Medical device operating enterprises and user units shall assist medical device manufacturers in fulfilling their recall obligations, promptly communicate and feedback medical device recall information in accordance with the requirements of the recall plan, and control and recall defective medical devices. Article 7 If a medical device operating enterprise or user unit discovers that the medical device it operates or uses is defective, it shall immediately suspend the sale or use of the medical device, promptly notify the medical device manufacturer or supplier, and notify the local province, autonomous region, or Report to the municipal drug regulatory department; if the user is a medical institution, it should also report to the health administrative department of the province, autonomous region, or municipality where it is located.
After receiving the report, the drug regulatory department of the province, autonomous region, or municipality where the medical device business enterprise or user unit is located shall promptly notify the drug regulatory department of the province, autonomous region, or municipality where the medical device manufacturer is located. Article 8 The drug regulatory department of the province, autonomous region, or municipality directly under the Central Government where the manufacturer of recalled medical devices or the overseas manufacturer of imported medical devices designates an agent in China is responsible for the supervision and management of medical device recalls. Drugs in other provinces, autonomous regions, or municipalities directly under the Central Government shall be responsible for the supervision and management of medical device recalls. Supervision and management departments should cooperate and assist in the relevant work of medical device recall within their jurisdiction.
The State Food and Drug Administration oversees the management of national medical device recalls. Article 9 The State Food and Drug Administration and the drug regulatory departments of provinces, autonomous regions, and municipalities directly under the Central Government shall establish a system for reporting and disclosing medical device recall information, promptly report relevant information to the health administrative departments at the same level, and adopt effective channels to announce defective information to the public. Medical device information and medical device recalls. Chapter 2 Investigation and Assessment of Medical Device Defects Article 10 Medical device manufacturers shall establish and improve a medical device quality management system and a medical device adverse event monitoring system, collect and record medical device quality problems and medical device adverse event information, and collect Analyze the information and investigate and evaluate possible defects in medical devices.
Medical device operating enterprises and user units shall cooperate with medical device manufacturing enterprises in conducting investigations on medical device defects and provide relevant information. Article 11 Medical device manufacturers shall promptly report the collected adverse event information of medical devices to the drug regulatory department in accordance with regulations. The drug regulatory department may analyze and investigate the adverse event information or possible defects of medical devices. Medical device Production enterprises, operating enterprises, and user units shall provide assistance. Article 12 The main contents of the evaluation of medical device defects include:
(1) Whether malfunction or injury has occurred during the use of the medical device;
(2) At present, Whether the injury will be caused under the use environment, and whether there are scientific literature, research, relevant tests or verifications that can explain the cause of the injury;
(3) The area and population characteristics involved in the injury;
(4) Degree of harm to human health;
(5) Probability of harm;
(6) Short-term and long-term consequences of harm;
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(7) Other factors that may cause harm to the human body.
Article 13 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 has caused serious health hazards;
< p>(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 is more likely to cause harm. Small but still in need of recall.
Medical device manufacturers should scientifically design recall plans and organize their implementation based on the recall classification and the sales and use of medical devices. Chapter 3 Voluntary Recall Article 14 If a medical device manufacturer discovers a defect in a medical device after conducting an investigation and evaluation in accordance with the requirements of Articles 10 and 12 of these Measures, it shall immediately decide to recall it.
If an overseas manufacturer of imported medical devices conducts a recall of medical devices overseas, it shall notify its designated agent in China to report to the State Food and Drug Administration in a timely manner; The designated agent within China is responsible for the specific implementation in accordance with the provisions of these Measures.