Notice of the Comprehensive Department of the National Food and Drug Administration on Strengthening the Quality Supervision of the Coronary Stents in the National Centralized Purchase of the National Drug Administration (2020) 10

The Drug Administration of all provinces, autonomous regions, and municipalities directly under the Central Government, and the Drug Administration of Xinjiang Production and Construction Corps:

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 the implementation of the main responsibility of enterprises, and strictly implement the responsibility of territorial supervision.

1.
Fully implement corporate responsibility for 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 enterprises shall strictly control raw material review and supplier management, carefully investigate hidden risks in the production process, effectively strengthen the management and control of the production process, quality control and finished product release, and take effective measures to ensure that the product quality meets the mandatory standards and the registered product technology Request

2.
Effectively strengthen the 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

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
.

3.
Do a good job in the 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, inspection and acceptance of medical devices.
Quality management work such as storage to ensure the quality, safety and traceability of the selected coronary stent products in the circulation and use links
.

Fourth, carefully carry out the quality sampling inspection of the 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 the daily supervision of samples taken 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

5.
Continue to strengthen 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 implement the adverse events in accordance with the "Administrative Measures for the Monitoring and Re-evaluation of Medical Device Adverse Events" (Order No.
1 of the National Health Commission of the State Administration for Market Regulation) 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

6.
Strengthen departmental coordination and information communication

Provincial drug regulatory agencies should attach great importance to the centralized procurement of high-value consumables and quality supervision of related products and enterprises, strengthen 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 products of the company, and coordinate to promote the smooth and orderly progress of large-scale procurement

All provincial-level 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 of the work of the provincial-level drug regulatory agencies in due course

Comprehensive Department of State Food and Drug Administration

November 10, 2020