Chapter I General Principles
Article 1 In order to strengthen the supervision and management of medical devices, control defective medical device products, eliminate the hidden danger of medical device safety, to ensure that the safety and effectiveness of medical devices to safeguard human health and safety of life, according to the "Regulations on the Supervision and Administration of Medical Devices," the formulation of these measures.
The second Chinese people*** and the recall of listed medical devices in the country and its supervision and management, the application of these measures.
Article 3 The medical device recall referred to in these Measures refers to the medical device manufacturer in accordance with the prescribed procedures for its has been marketed and sold in a certain category, model or batch of defective medical device products, to take warning, inspection, repair, re-labeling, modification and improvement of the instructions, software updates, replacement, recovery, destruction and other ways to deal with the behavior.
The medical device manufacturer referred to in the preceding paragraph, refers to the territory of the medical device product registrant or filer, imported medical devices of foreign manufacturers in China designated agent.
Article 4 The defective medical device products referred to in these measures include:
(1) products that may endanger human health and life safety under normal use of unreasonable risk;
(2) products that do not comply with the mandatory standards, registered or filed product technical requirements;
(3) products that do not comply with the relevant provisions of the medical device production, operation and quality management. Quality management of the relevant provisions of the product may be unreasonable risk;
(d) other products need to be recalled.
Article V medical device manufacturers are responsible for the control and elimination of product defects, should take the initiative to implement the recall of defective products.
Article VI medical device manufacturers shall establish and improve the medical device recall management system in accordance with the provisions of these measures, collect medical device safety-related information, investigate and evaluate possible defective products, and recall defective products in a timely manner.
Imported medical devices of foreign manufacturers in China designated agent shall be implemented only outside the medical device recall information reported to the State Food and Drug Administration in a timely manner; where the implementation of the recall involves the implementation of the territory, the designated agent in China shall be in accordance with the provisions of this approach to the implementation of the organization.
Medical device business enterprises, the use of units should actively assist medical device manufacturers to investigate and assess defective products, take the initiative to cooperate with the manufacturer to fulfill the recall obligations, in accordance with the recall plan to convey timely, feedback medical device recall information, control and recovery of defective products.
Article VII of the medical device business enterprises, the use of medical devices found to be operating, the use of medical devices may be defective products, shall immediately suspend the sale or use of the medical device, and promptly notify the medical device manufacturer or supplier, and to the location of the province, autonomous region, municipality directly under the central food and drug supervision and management department; the use of the unit of the medical institutions, but also shall also be the same time to the location of the province, Autonomous regions, municipalities directly under the Central Health Administration report.
Medical device business enterprises, the use of the local province, autonomous region, municipality directly under the central food and drug supervision and management department shall promptly notify the medical device manufacturer of the local province, autonomous region, municipality directly under the central food and drug supervision and management department.
Article VIII of the recall of medical devices, the manufacturer of the province, autonomous region, municipality directly under the Central Food and Drug Administration is responsible for the supervision and management of medical device recall, other provinces, autonomous regions, municipalities directly under the Central Food and Drug Administration shall cooperate with the recall of medical devices in the administrative region of the relevant work.
The State Food and Drug Administration to supervise the national medical device recall management.
Article IX The State Food and Drug Administration and the provinces, autonomous regions and municipalities directly under the Central Food and Drug Administration shall, in accordance with the medical device recall information and information disclosure system, to take effective means to the community to publish defective product information and recall information, if necessary, to the same level of the health administrative department notification of relevant information.