Notes on the Measures for the Supervision and Administration of the Quality of the Use of Medical Devices

December 1st, 2015 - On October 21st, 2015, the State Administration of Food and Drug Administration issued General Administration Order No. 18, "Measures for the Supervision and Administration of the Quality of The Use of Medical Devices" (hereinafter referred to as the Measures), which will come into effect on February 1, 2016., drafting background, the quality
medical devices in the use of the link is essential to ensure the safety and effectiveness of the use of firearms. The original Regulations on the Supervision and Administration of Medical Devices, which were implemented in 2000, regulate the use of medical devices, mainly related to the procurement of medical devices and the disposal of single-use medical devices. In practice, the hospital procurement of medical equipment channels are not standardized, the problem of not strict ticketing work still exists, many hospitals ignore the maintenance and maintenance of medical equipment, resulting in patient damage cases occur from time to time. In 2014, the Regulations on the Supervision and Administration of Medical Devices (State Council Order No. 650) (hereinafter referred to as the Regulations) revised and issued by the State Council have substantially increased the regulations on the use of medical devices, such as the refinement of the inspection and recording system for incoming purchases, the addition of safety management obligations for medical devices used, and the enrichment of regulatory means, which have enriched the measures for the quality management of the use of medical devices after they are put on the market. These Measures, as supporting regulations of the Regulations, elaborate the system of supervision of the quality of medical devices used in accordance with the division of responsibilities between the food and drug regulatory departments and the competent departments of health and family planning., basic framework and main contents
The Measures consist of 6 chapters and 35 articles, including:
Chapter I general rules, a total of 6 articles. The requirements of legislative purpose, scope of application, regulatory authority, establishment of quality management system for the use of medical devices and responsibility for quality management of medical devices used by the unit are defined.
, acceptance and storage of the second chapter, a total of 6 articles. Medical device users are required to implement unified management of medical device procurement, which shall be unified by their designated departments or personnel. Establish a system for the implementation of in-stock inspection and record-keeping, verify the supplier's qualifications and product qualification documents for purchased medical equipment, and clarify the period of preservation of the purchase inspection records in accordance with the authorization of Article 32 of the Regulations. The requirements of places and facilities for the storage of medical devices, the monitoring and recording requirements for the environmental conditions of temperature and humidity, and the requirements for the regular inspection and recording of storage medical devices are stipulated.
, maintenance and transfer of the third chapter of the National People's Republic of China, a total of 9 articles. Medical device use units are required to establish a pre-use quality inspection system for medical devices, a record system for the use of implanted and intervening medical devices, and a management system for the maintenance and repair of medical devices. It is stipulated that the units using medical devices shall carry out regular inspection, inspection, calibration, maintenance and maintenance of medical devices in accordance with the requirements of the product description. It is further clarified that medical device production and operation enterprises may require medical device production and operation enterprises to provide medical device maintenance and maintenance services in accordance with the contract, or may entrust conditional and capable maintenance service institutions or carry out maintenance and repair of medical devices on their own; It is stipulated that the transfer of medical devices in use between the units using medical devices shall be subject to the examination and qualification of qualified inspection institutions before the transfer can take. If a medical device is donated between the units using medical devices, the relevant provisions of the transfer shall be referred to.
supervision and management of chapter four, a total of 5 articles. The food and drug regulatory department shall supervise and inspect the establishment and implementation of the quality management system for the use of medical devices by the units of use, and shall, in accordance with the principles of risk management, exercise key supervision over medical devices with higher risks; The food and drug regulatory department shall strengthen spot checks and inspections of medical devices used in the use of medical devices, and the food and drug regulatory departments at or above the provincial level shall issue timely announcements on the quality of medical devices. The units using medical devices shall conduct self-examination on the quality management of their medical devices.
Chapter V legal liability, a total of 6 articles. The circumstances in which the relevant violations committed by the units using medical devices shall be punished in accordance with the provisions of Articles 66, 67 and 68 of the Regulations. In accordance with the authority to set administrative penalties in accordance with the regulations, warnings and fines are prescribed for violations of these Measures by medical device users, medical device production and operation enterprises and maintenance service institutions.
by-laws of Chapter VI of the Law, a total of three articles. It is clarified that the quality management of medical devices used in clinical trials in medical device use units shall be carried out in accordance with the relevant provisions of clinical trials of medical devices, and that the supervision of the use of medical devices shall be carried out in accordance with the provisions of the Department of Health and Family Planning. The by-laws also set a date for the implementation of the Measures as 1 February 2016.
medical device use units are the direct operators of medical devices and the key to ensuring the safety of firearms. The Measures urge medical device users to establish and implement a medical device use management system covering the whole process of quality management through strict quality inspection and management requirements, strengthening maintenance and maintenance management, improving the transfer and donation management of medical devices in use, and strengthening classification and credit supervision. The introduction of the Measures further enriches the supporting regulatory 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 firearms. (Pharmaceutical Network)