The Weifang Market Supervision Bureau completed the second round of new crown virus nucleic acid testing agencies in medical device supervision and inspection

In order to further do a good job of quality supervision of the use of new coronary virus nucleic acid testing medical devices, and ensure the smooth progress of nucleic acid testing and screening, from August 15th to 30th, the Weifang Market Supervision Bureau organized the completion of the second round of the 75 nucleic acid testing agencies in the city. Cover the supervision and inspection, and make every effort to ensure the quality and safety of the epidemic prevention and control of medical equipment.

The first is to conduct a comprehensive investigation and improve the supervision file. On the basis of comprehensive arrangements in the early stage, actively maintain a close communication with the municipal Health and other departments, timely and in a timely and comprehensive grasp of the number of cores of nucleic acid detection institutions, and establish a work ledger in divided into regions and categories to make the bottom number, the situation, and the information accurate.

The second is to highlight the key points and supervise all aspects. According to the "Guidelines for the Inspection of Nuclear Virus Nucleic acid Detection Agency in Shandong Province", focusing on the qualifications, purchase inspections, cold chain transfer, storage and transportation conditions, quality records, etc. This is ordered to rectify the time limit to ensure that the problem of hidden dangers shall be cleared.

The third is to strengthen the promotion and urge the implementation of the main responsibility. Adhere to the border inspection, side training, and border law, and simultaneously carry out the "Regulations on the Supervision and Administration of Medical Devices" and "Measures for Quality Supervision and Management of Medical Devices", and focus on the storage conditions of the nucleic acid testing agent -20 ° C ± 5 ° C. Personnel conducts relevant knowledge training for medical device cold chain management, urge the testing agency to strictly abide by the regulations of medical device regulations and regulations, and control strict procurement, acceptance, storage, use, etc. to ensure the quality and effectiveness of the new crown virus nucleic acid test agent.

In the next step, the Weifang Market Supervision Bureau will further increase supervision and inspection, urge nucleic acid testing agencies to implement the main responsibility, ensure that the quality, safety and reliability of medical equipment will be carried out smoothly, and the prevention and control of the epidemic will be carried out smoothly.

- END -