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Latest measures for supervision and management of the quality of medical devices

Latest measures for supervision and management of the quality of medical devices

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  • Time of issue:2020-09-01
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(Summary description)Article 1 These measures are formulated in accordance with the regulations on the supervision and administration of medical devices in order to

Latest measures for supervision and management of the quality of medical devices

(Summary description)Article 1 These measures are formulated in accordance with the regulations on the supervision and administration of medical devices in order to

  • Categories:News Center
  • Author:
  • Origin:
  • Time of issue:2020-09-01
  • Views:0
Information

Chapter I General
 
Article 1 These measures are formulated in accordance with the regulations on the supervision and administration of medical devices in order to strengthen the supervision and management of the quality of medical devices and ensure the safety and effectiveness of medical devices.
 
Article 2 the quality management and supervision and management of medical devices in the use link shall abide by these measures.
 
Article 3 the State Food and drug administration is responsible for the supervision and administration of the quality of the use of medical devices nationwide. The local food and drug administration departments at or above the county level shall be responsible for the supervision and administration of the use quality of medical devices in their respective administrative regions.
 
The food and drug administration department at a higher level is responsible for guiding and supervising the food and drug administration departments at lower levels to carry out the supervision and management of the use quality of medical devices.
 
Article 4 the medical device user shall, in accordance with these measures, provide quality management institutions or quality management personnel suitable for its scale, establish a quality management system covering the whole process of quality management, and bear the quality management responsibility of the unit in using medical devices.
 
Encourage medical device users to use information technology to manage the quality of medical devices.
 
Article 5 the medical devices sold by the medical device production and operation enterprises shall meet the mandatory standards and the technical requirements of the products registered or filed. The medical device production and operation enterprise shall provide after-sales service of medical devices, guide and cooperate with the medical device users in the quality management work according to the contract with the medical device user.
 
Article 6 if the medical device user finds that the medical devices used have adverse events or suspicious adverse events, they shall report and deal with them in accordance with the relevant provisions of the monitoring of adverse events of medical devices.
 
Chapter II procurement, acceptance and storage
 
Article 7 the medical device user shall implement unified management over the purchase of medical devices, and the designated departments or personnel shall purchase medical devices uniformly. Other departments or personnel shall not purchase medical devices by themselves.
 
Article 8 the medical device user shall purchase medical devices from the qualified medical device production and operation enterprises, and ask for and inspect the qualification of the supplier, the registration certificate of medical devices or the record keeping certificate, etc. The medical devices purchased shall be verified with the product qualification certificate and accepted according to the regulations. For medical devices with special storage and transportation requirements, it is also necessary to verify whether the storage and transportation conditions meet the requirements of product specification and label marking.
 
Article 9 the medical device user shall record the inspection of the purchased goods truthfully, completely and accurately. The incoming inspection records shall be kept for 2 years after the expiration of the prescribed service period of medical devices or 2 years after the termination of use. The purchase inspection record of large medical devices shall be kept for 5 years after the expiration of the prescribed service period of medical devices or 5 years after the end of use; the records of incoming inspection of implanted medical devices shall be kept permanently.
 
The medical device user shall properly keep the original data of the third type medical devices purchased, so as to ensure the traceability of the information.
 
Article 10 the place, facilities and conditions for medical devices storage by medical device users shall be suitable for the type and quantity of medical devices, and meet the requirements of product instruction and label marking and the safe and effective use requirements; if there are special requirements for the temperature and humidity and other environmental conditions, the temperature and humidity data in the storage area shall also be monitored and recorded.
 
Article 11 the medical device user shall regularly inspect and record the stored medical devices according to the storage conditions, the validity period of medical devices and other requirements.
 
Article 12 the medical device user shall not purchase or use medical devices that have not been registered or filed in accordance with the law, have no certificate of conformity, and medical devices that are expired, invalid or eliminated.
 
Chapter III use, maintenance and transfer
 
Article 13 the medical device user shall establish a quality inspection system before using the medical devices. Before using medical devices, the inspection shall be conducted according to the relevant requirements of the product specification.
 
Before using sterile medical devices, the packaging and validity period of medical devices directly in contact with them shall be checked. If the package is damaged, the mark is unclear, the expiration date is exceeded or the use safety and effectiveness may be affected, it shall not be used.
 
Article 14 the medical device user shall establish the use record for the implanted and interventional medical devices, and the use records of the implanted medical devices shall be kept permanently. The relevant data shall be included in the information management system to ensure the traceability of the information.
 
Article 15 the medical device user shall establish a management system for the maintenance and maintenance of medical devices. For medical devices requiring regular inspection, inspection, calibration, maintenance and maintenance, they shall be inspected, inspected, calibrated, maintained, maintained and recorded in accordance with the requirements of the product manual, and analyzed and evaluated in time to ensure that the medical devices are in good condition.
 
For large-scale medical devices with long service life, they shall establish use files one by one, and record their use and maintenance. The record retention period shall not be less than 5 years after the expiration of the prescribed service period of medical devices or 5 years after the termination of use.
 
Article 16 the medical device user shall use the medical devices in accordance with the requirements of the product specification and other requirements. Disposable medical devices shall not be reused. Those used shall be destroyed and recorded in accordance with relevant provisions of the state.
 
Article 17 the medical device user may, in accordance with the provisions of the contract, require the medical device production and operation enterprise to provide medical device maintenance and maintenance services, or entrust qualified and capable maintenance service institutions to carry out medical device maintenance and repair, or to carry out maintenance and maintenance of medical devices on its own

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