In order to do a good job in the emergency response to particularly major public health emergencies and other emergencies that seriously threaten public health, guide and regulate the emergency use of medical devices.
When there is a particularly serious public health emergency or other emergency that seriously threatens public health.
Particularly major public health emergencies shall comply with the circumstances provided for in the National Emergency Plan for Public Health Emergencies.
Emergencies that seriously threaten public health shall meet the circumstances identified by ***.
Medical devices intended for emergency use shall be medical devices that have no similar product registration in China, or products that cannot meet the needs of particularly major public health emergencies or other emergencies that seriously threaten public health despite the registration of similar products.
The emergency use medical devices referred to in these regulations do not include Class I medical devices.
The National Health Commission and the National Bureau of Disease Control and Prevention are responsible for putting forward recommendations for the proposed emergency use of medical devices in accordance with their duties.
Provincial-level health departments and disease control departments are to manage the use of emergency-use products.
The State Food and Drug Administration is responsible for organizing expert demonstrations to determine the list of medical devices that can be used urgently.
The provincial drug regulatory department shall supervise and manage, and guide the enterprise to organize production and carry out adverse event monitoring in accordance with the requirements of the quality management system.
1.After receiving the written recommendation list, the State Food and Drug Administration shall, within 2 days, in conjunction with relevant units, determine the list of medical device enterprises in accordance with the corresponding conditions;
2.The State Food and Drug Administration shall entrust the medical device technical review agency of the State Food and Drug Administration to organize an expert demonstration meeting within 2 days after the list is determined. The medical device technical review agency of the State Food and Drug Administration shall organize and convene an expert demonstration meeting within 2 days after receiving the entrustment;
3.Before convening the expert demonstration meeting, the medical device technical review agency of the State Food and Drug Administration shall notify the enterprises in the list of medical devices to be used urgently to prepare the required materials for the demonstration and submit them at the expert demonstration meeting;
4.The expert demonstration will be carried out by the expert group to review the data, and the voting method will be used to decide whether the product is recommended for emergency use (more than 2 3 in favor of the argument);
5.The medical device technical evaluation agency of the State Food and Drug Administration shall submit the opinions of the expert group to the State Food and Drug Administration within 1 day after the end of the expert demonstration meeting, and the State Food and Drug Administration shall give written feedback to the National Health Commission and the National Disease Control and Prevention Bureau within 2 days;
6.For emergency use that has been approved by experts, the State Food and Drug Administration shall notify the competent department of industry and information technology, and notify the relevant provincial departments in conjunction with the National Health Commission and the National Disease Control and Prevention Bureau. The notice includes a list of emergency use products and the corresponding use plan, including the product name, enterprise name, scope of use, period of use, etc.; For the emergency use of imported medical devices, the State Food and Drug Administration shall notify the General Administration of Customs of the relevant situation.
1) A description of the enterprise's application for the use of the product for emergency use;
2) The basic information and qualification documents of the enterprise, of which the qualification documents can be provided with reference to the relevant requirements of the relevant documents in the registration and application materials of medical devices or in vitro diagnostic reagents; If other enterprises are entrusted to produce, the qualification documents, entrustment contracts and quality agreements of the entrusted enterprises shall be provided; Where they have received an administrative punishment in the past 3 years, they shall truthfully explain it;
3) Product review data;
4) The technical requirements of the product, the inspection report carried out in accordance with the technical requirements and the instructions for the use of the product;
5) Preclinical research data;
6) Clinical data, such as data on clinical trials carried out at home and abroad, clinical data of medical devices of the same variety, clinical use data, etc.;
7) Product capacity description, including production capacity, inventory, raw material security, etc.;
8) The construction and operation of the enterprise's quality management system, including the inspection of the enterprise by the domestic and foreign drug regulatory departments or quality management system certification bodies in the past 5 years (if any), as well as the self-inspection report of the enterprise's quality management system;
9) Product quality and safety responsibility commitment.
1) Whether the product is finalized and whether the production process is stable;
2) Whether the corresponding information of the product can preliminarily prove the scientificity, safety and effectiveness of the product design;
3) Whether the instructions and labels of the product meet the needs of emergency use;
4) Whether the proposed scope of application and use period of the product are in line with disease prevention and control, clinical diagnosis and urgent needs;
5) Whether the enterprise has experience in the production of similar products;
6) Whether the enterprise has the ability to perform the main responsibility;
7) Whether the production quality management system of the enterprise is sound and effectively operated;
8) The actual production capacity of the enterprise and the ability to guarantee emergency use.
1) Where a particularly major public health emergency or other emergency that seriously threatens public health has ended, or the emergency use period has been reached;
2) There are major safety problems or quality defects in medical devices for emergency use;
3) The registered product can meet the needs of use.
Welcome to click on the above fan me to pay attention to [Jiushun Medical Equipment Technical Service] medical equipment knowledge is not lost!