Medical device quality management system

Medical device quality management systemContent formulated to strengthen the supervision and management of the quality of medical device use and ensure the safe and effective use of medical devices. The free version of the medical device quality management system is provided by Huajun Software Park for free download. The source file is in docx format, which is convenient for users to edit by themselves. For more information about the medical device quality management system, please pay attention to Huajun Software Park for free downloads.

General Principles of Medical Device Quality Management System

​​ 1. The quality management and supervision of medical devices during use shall comply with these Measures.

​​ 2. The State Food and Drug Administration is responsible for the supervision and management of the quality of medical devices nationwide. Local food and drug regulatory authorities at or above the county level are responsible for the supervision and management of the use quality of medical devices within their respective administrative regions.

​ 3. Medical devices sold by medical device manufacturing and operating enterprises shall comply with mandatory standards and registered or filed product technical requirements. Medical device production and operation enterprises shall provide medical device after-sales services in accordance with the contracts with medical device users, and guide and cooperate with medical device users to carry out quality management work.

​​ 4. If a medical device user unit discovers that an adverse event or suspected adverse event occurs in the medical device used, it shall report and handle it in accordance with the relevant regulations on adverse event monitoring of medical devices.

Medical device quality management system considerations

If a medical device user unit has any of the following circumstances, the food and drug administration department at or above the county level will order it to make corrections within a time limit and give a warning; if it refuses to make corrections, it will be fined not more than 10,000 yuan:

(1) Failure to have a medical device quality management organization or quality management personnel commensurate with its scale as required, or failure to establish a use quality management system covering the entire quality management process as required;

(2) Failure to uniformly purchase medical devices by designated departments or personnel as required;

(3) Purchasing and using unregistered Class I medical devices, or purchasing Class II medical devices from unregistered business enterprises;

(4) The place, facilities and conditions for storing medical devices are not suitable for the type and quantity of medical devices, or the stored medical devices are not regularly inspected and recorded in accordance with the storage conditions, validity period of medical devices and other requirements;

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