[Introduction] On October 21, 2015, the State Food and Drug Administration issued the No. 18 General Administration Order on the Supervision and Administration of Medical Device Use Quality (hereinafter referred to as the “Measures”), which will be implemented on February 1, 2016. .
On October 21, 2015, the State Food and Drug Administration issued the No. 18 General Administration Order “Measures for the Supervision and Administration of the Quality of Medical Device Use” (hereinafter referred to as the “Measures”), which will be implemented on February 1, 2016.
I. Drafting background
The quality of the medical device in use is critical to ensuring the safety and effectiveness of the device. The original "Medical Device Supervision and Management Regulations" implemented in 2000 regulate the use of medical devices, mainly involving the procurement of medical devices and the disposal of disposable medical devices. The content is relatively thin. In practice, the hospital procurement of medical equipment channels is not standardized, the problem of claiming that the ticket is not rigorous still exists; many hospitals ignore the maintenance and repair of medical equipment, resulting in cases of patient damage. The Regulations on the Supervision and Administration of Medical Devices issued by the State Council in 2014 (No. 650 of the State Council) (hereinafter referred to as the “Regulations”) have greatly increased the provisions for the supervision of the use of medical devices, such as refining the system of inspection and record of incoming goods. The use of the unit's medical device safety management obligations, enrichment of regulatory tools, etc., enriched the use of quality management measures after the listing of medical devices. As the supporting regulations of the "Regulations", the "Measures" is based on the division of responsibilities between the food and drug supervision departments and the health and family planning authorities, and the quality control system for medical devices in the use links has been refined.
Second, the basic framework and main content
The "Measures" consists of 6 chapters and 35 articles. The main contents include:
The first chapter is a total of six articles. The purpose of legislation, scope of application, regulatory authority, establishment of quality management system for medical device users, and responsibility for quality management of medical devices used by the unit are clarified.
Chapter II purchase, acceptance and storage, a total of six. Medical device users are required to implement unified management of medical device procurement, and their designated departments or personnel shall purchase them in a unified manner. Establish an implementation inspection and record system, and verify the supplier qualification and product qualification certificate for the purchased medical devices; and clarify the retention period of the purchase inspection records in accordance with the authorization of Article 32 of the Regulations. It specifies the requirements for the location and facilities for storing medical devices, the monitoring and recording requirements for temperature and humidity environmental conditions, and the requirements for periodic inspection records for stored medical devices.
The third chapter uses, maintains and transfers a total of nine articles. Medical device users are required to establish a quality inspection system for medical devices, a record system for implanted and interventional medical devices, and a medical device maintenance and repair management system. The medical device use unit shall be required to carry out regular inspection, inspection, calibration, maintenance and maintenance of medical devices in accordance with the requirements of the product manual. It is further clarified that the medical device use unit may require the medical device production and operation enterprise to provide the medical device maintenance and repair service according to the contract, or may entrust the maintenance service organization with the condition and capability or perform maintenance and repair on the medical device by itself; the use unit entrusts a third party or If the medical device is to be repaired and maintained by itself, the medical device production and operation enterprise is obliged to provide the materials and information necessary for maintenance and repair such as maintenance and repair manuals, parts and repairs, and maintenance passwords in accordance with the contract. Where the medical device used by the medical device is transferred, it shall be transferred after being inspected by a qualified inspection agency. Where medical devices are donated between medical device users, the relevant provisions of the transfer shall be handled.
The fourth chapter supervises and manages a total of five articles. It is stipulated that the food and drug supervision department shall supervise and inspect the establishment and implementation of the quality management system for medical devices used by the users, and implement the key supervision of medical devices with higher risks in accordance with the principle of risk management; The maintenance service agency conducts an extended inspection. The food and drug supervision department shall strengthen the spot check on the medical devices in use, and the food and drug supervision departments at or above the provincial level shall issue the medical device quality announcements in a timely manner. Medical device users should conduct self-examination of their medical device quality management work.
Chapter V Legal Responsibilities, a total of six articles. It clarified the circumstances in which the illegal acts of medical device users were punished in accordance with the provisions of Articles 66, 67 and 68 of the Regulations. In accordance with the regulations, the authority to set administrative penalties shall be punishable by warnings and fines for medical device users, medical device production and operation enterprises, and maintenance service agencies in violation of these Measures.
Chapter VI Supplementary Provisions, a total of three articles. It is clarified that the quality management of clinical trial medical devices in medical device users is carried out in accordance with the relevant provisions of clinical trials for medical devices, and the supervision of the use of medical devices is carried out in accordance with the regulations of the health and family planning department. The Annex also stipulates that the implementation date of the Measures is February 1, 2016.
The medical device user is the direct operator of the medical device and is the key to ensuring the safety of the device. The "Measures" precisely through strict quality inspection management requirements, strengthen maintenance and repair management, improve the use of medical device transfer and donation management, and strengthen classified supervision and credit supervision, etc., urge medical device users to establish and implement medical services covering the entire process of quality management. Device management system. The promulgation of the "Measures" has further enriched the supporting regulations system of the "Regulations on the Supervision and Administration of Medical Devices", which is of great significance for strengthening the supervision and management of medical devices and ensuring the safety of medical devices.