The "Administrative Measures" revolves around medical devices, from their procurement, acceptance, use, maintenance, supervision and management to the quality management of legal responsibilities. The applicable units of medical devices, production and business units, and video drug supervision and management departments have their respective responsibilities, The authority has been clearly stipulated to strengthen the quality supervision and management of the use of medical devices and ensure the effectiveness of the use of medical devices.

 

 

Medical device users: unified management of all processes and establishment of real-time records

 

 

The general provisions of the administrative measures clearly stipulate that medical device users shall be equipped with medical device quality management institutions or quality management personnel suitable for their scale, establish a use quality management system covering the whole process of quality management, and undertake the quality management responsibility of using medical devices in their own units.

 

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Procurement Personnel Specific

 

The purchase of medical devices by a medical device user shall be uniformly purchased by its designated department or personnel, and other departments or personnel shall not purchase medical devices on their own.

 

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Procurement channel right way

 

 

Procurement channels need to select formal and qualified medical device production and operation enterprises. It is not allowed to purchase and use medical devices that are not registered or filed in accordance with the law, have no qualified certification documents, and are expired, invalid, or eliminated.

 

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Completion of acceptance information

 

The user unit needs to record the purchase inspection situation truthfully, completely and accurately during the acceptance. And according to different types of medical devices, according to the number of years to keep inspection records. In particular, for the third type of medical devices, the user needs to keep its original data to ensure the traceability of information.

 

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Proper storage conditions

 

The places, facilities and conditions for storing medical devices by medical device users shall be compatible with the types and quantities of medical devices; if there are requirements for environmental conditions such as temperature and humidity, the temperature and humidity of the storage area shall also be monitored and recorded; according to the storage Conditions, medical device validity period and other requirements, regularly check and record the stored medical devices.

 

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Use process

 

Medical devices should go through the quality inspection process before use, and can be used only after the inspection is correct. In use, sterile medical devices, implantable medical devices and other different devices need to be used and recorded according to the instructions.

 

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Regular maintenance

 

Regular inspection, inspection, calibration, maintenance, maintenance of the corresponding medical devices, and timely molecular evaluation, to ensure that the medical devices in good condition. For medical devices with long service life, use files shall be established and properly kept according to the number of years. For medical devices with hidden dangers, they shall immediately stop using them and notify them for maintenance; if they still fail to meet the use standards after maintenance, they shall not continue to be used and shall be disposed of in accordance with relevant regulations.

 

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Transfer Compliance Process

 

The transferor must first ensure the validity of the transferred medical device. The two parties shall sign an agreement, hand over the product manual, copy of the use and maintenance record files and other materials, and pass the inspection by a qualified inspection agency before the transfer. The transferee shall conduct inspection in accordance with the provisions of Article 8 of these Measures on the inspection of incoming goods, and shall not use it until it meets the requirements. The donation process is the same as the transfer rules. Both require legal documents and product quality inspection.

 

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Medical device production and operation enterprises

Product quality clearance certification, provide relevant documents and follow-up services

 

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Article 5 of the General Provisions of the Management Method:

 

 

Medical devices sold by medical device production and operation enterprises shall meet the mandatory standards and the technical requirements for registered or filed products. The medical device production and operation enterprise shall, in accordance with the contract agreement with the medical device user, provide medical device after-sales service, guide and cooperate with the medical device user to carry out quality management work.

 

During the procurement process of the medical device user, it is necessary to provide the product qualification certificate, instruction manual and other instruction documents. For medical devices with maintenance services specified in the contract, the manufacturer and operator need to provide corresponding repair, maintenance and other services.

 

 

 

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Food and Drug Administration

 

 

Third-party implementation of supervision and management, the establishment of supervision and management files

 

The "Management Methods" clearly requires that the food and drug supervision and administration department shall supervise and inspect the establishment and implementation of the quality management system for the use of medical devices by medical device users, and shall record the results of the supervision and inspection and include them in the supervision and management files. Improve supervision and timeliness in terms of focus, frequency and coverage.

 

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Self-inspection Report of the Unit

 

Medical device users shall, in accordance with these Measures and the medical device use quality management system established by the unit, conduct a comprehensive self-examination of the quality management of medical devices every year, and form a self-examination report. The food and drug supervision and administration department shall conduct spot checks on the self-examination reports of medical device users during supervision and inspection.

 

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Sampling of medical devices in use

Article 25 of the "Administrative Methods" requires that the food and drug supervision and administration department should strengthen the random inspection of medical devices in the use of links. The food and drug supervision and administration department at or above the provincial level shall, in accordance with the results of spot checks, issue a timely announcement on the quality of medical devices.

 

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Verify and handle the event

Individuals and organizations have the right to report to the food and drug supervision and administration department where the medical device user is located if they find that the medical device user has violated these Measures. The food and drug supervision and administration department that receives the report shall verify and handle it in a timely manner. If it is verified to be true, the informant shall be rewarded in accordance with the relevant provisions.

 

In addition, the "Management Method" classifies and summarizes the behaviors that do not conform to the regulations, and corresponds to the "Regulations on the Supervision and Administration of Medical Devices" and imposes penalties.

 

The promulgation of the "Medical Device Use Quality Supervision and Management Measures" clearly strengthened the use and effectiveness of medical devices, improved the management and supervision mechanism of medical devices, and further enriched the supporting regulatory system of the "Medical Device Supervision and Management Regulations.

Source: Biological Exploration