China News Service, November 11th. According to the website of the State Food and Drug Administration, the State Food and Drug Administration recently issued the "Notice on Strengthening the Quality Supervision of Selected Coronary Stents in National Centralized Purchases" (hereinafter referred to as the "Notice").
The "Notice" clarified that the provincial drug regulatory authorities should strengthen the quality inspection of coronary stent products, and carry out quality inspections of key items in the production, circulation, and use of samples based on the problems found in daily supervision.
The random inspection of the selected enterprises shall be combined with the on-site inspection of the production enterprises, and the random inspection shall be conducted at least once a year.
According to the "Notice", recently, the National Medical Insurance Administration, in conjunction with relevant departments, organized a centralized procurement of coronary stents.
The provincial drug regulatory authorities must fully understand the importance of this centralized procurement work, always adhere to the people's health as the center, fully implement the "four strictest" requirements for drug safety, promote enterprises to implement the main responsibility, and strictly implement the territorial regulatory responsibility. Effectively guarantee the quality and safety of centralized procurement of coronary stents.
The relevant work requirements are as follows:
The first is to fully implement the main responsibility of enterprise quality and safety.
Coronary stent manufacturers must firmly establish the sense of responsibility for quality, strictly follow the requirements of production quality management specifications, improve the quality management system and maintain effective operation, and ensure that the products delivered meet the quality requirements.
The selected companies shall strictly conduct raw material review and supplier management, carefully investigate hidden risks in the production process, effectively strengthen the control of the production process, quality control and finished product release, and take effective measures to ensure that product quality meets mandatory standards and registered product technology Claim.
Product identification must be done in accordance with the "Announcement of the National Medical Products Administration, National Health Commission, and the National Medical Insurance Bureau on Deepening the Pilot Program and Implementing the First Batch of Unique Identification of Medical Devices" (No. 106, 2020), and establish and improve coronary stents Product traceability system, effectively do a good job in product recall, traceability and related work.
The second is to effectively strengthen supervision and inspection of production links.
Provincial-level drug regulatory agencies must adhere to the problem-oriented approach, strengthen the daily supervision of coronary stent manufacturers, and urge enterprises to implement their main responsibilities.
The provincial drug regulatory authorities where the selected companies are located should increase their on-site inspections, organize capable professional forces to supervise and inspect the entire project of the selected companies at least once a year, and report the inspection results to the Department of Device Supervision of the State Food and Drug Administration at the end of each year.
The latest supervision and inspection should be completed before the end of 2020.
Key inspections: whether the production and inspection personnel have received training appropriate to their positions, and have the corresponding knowledge and skills; whether the key raw materials such as stent platform materials, coating polymers, drugs, etc. have changed; pickling polishing, drug coating coating Whether the key processes/special processes such as sterilization are consistent with the verification/confirmation; whether the clean room (area) control meets the requirements; whether the requirements of process inspection, finished product inspection and finished product release are strictly implemented; problems found in production , Whether it is possible to analyze the reasons in depth and take timely measures.
The third is to do a solid job of supervision and inspection of circulation and use links.
The provincial drug regulatory authorities urge and guide the drug regulatory departments in cities and counties to strengthen the supervision of circulation and use, and urge the delivery units of selected coronary stent products to strictly implement the requirements of medical device management quality management standards, and take effective measures to ensure that they are selected. The transportation and storage process of coronary stent products meet the requirements of product instructions or labeling, and make corresponding records of transportation and storage; supervise and urge medical institutions to strictly follow the requirements of the "Medical Device Use Quality Supervision and Administration Measures" to do a good job in the procurement, acceptance and inspection of medical devices Storage and other quality management work to ensure the quality, safety and traceability of the selected coronary stent products in circulation and use.
The fourth is to earnestly carry out random inspections on the quality of selected varieties.
The provincial drug regulatory authorities should strengthen the quality sampling of coronary stent products, and carry out quality inspections of key items based on the problems found in daily supervision and sampling of samples from production, circulation, and use.
The random inspection of the selected enterprises shall be combined with the on-site inspection of the production enterprises, and the random inspection shall be conducted at least once a year.
The unqualified products shall be strictly investigated and dealt with in accordance with the law, a quality announcement shall be issued, and the medical insurance department and health administration department at the same level shall be notified.
Relevant medical device inspection agencies should give priority to the commissioned inspection of the selected coronary stent products by the provincial drug regulatory authority, and arrange the inspection in time and issue a report.
The provincial drug regulatory authority where the selected company is located shall report the annual quality sampling and disposal results of coronary stent products to the Department of Device Supervision of the State Drug Administration in the first quarter of the following year.
The State Food and Drug Administration will organize special random inspections of selected products.
Fifth, continue to strengthen the monitoring of adverse events.
The provincial drug regulatory authorities should strengthen the monitoring of adverse events of coronary stent products, and urge the selected companies to follow the "Medical Device Adverse Event Monitoring and Re-evaluation Management Measures" (State Administration for Market Regulation and National Health Commission Order No. 1). The main responsibility of event monitoring is to establish a complete adverse event monitoring system, discover, investigate and evaluate suspicious adverse events in a timely manner, and submit regular risk evaluation reports on time.
The monitoring technical agency shall promptly organize the investigation and disposal of abnormal risk signals and aggregated signals found in monitoring, and report to the corresponding supervisory authority.
The sixth is to strengthen departmental coordination and information communication.
Provincial-level drug regulatory agencies should attach great importance to the centralized procurement of high-value consumables and the quality supervision of related products and enterprises, strengthen the coordination and cooperation with health, medical security and other departments, and effectively ensure the safety and effectiveness of selected medical devices.
The provincial drug regulatory authority where the selected company is located should supervise the company to implement product supply guarantee responsibilities, strictly implement the relevant regulations and requirements of the production suspension report, timely grasp the production and sales of the selected product of the company, and coordinate to promote the smooth and orderly progress of mass procurement.
It is necessary to establish a sound emergency response mechanism for coronary stent quality problems, properly handle hot issues, open complaints and reporting channels, and promptly investigate and punish violations of laws and disciplines.
The "Notice" pointed out that the provincial drug regulatory agencies should report to the State Food and Drug Administration in a timely manner when they encounter major problems in their supervision work, and the State Drug Administration will conduct supervision and inspection on the work of the provincial drug regulatory agencies in due course.