Article 1 In order to strengthen the supervision and management of the use of medical devices to ensure that the use of medical devices is safe and effective, according to the "Supervision and Management of Medical Devices Regulations", the development of this approach.
Second the use of medical equipment quality management and supervision and management, shall comply with these measures.
Article 3 State Food and Drug Administration is responsible for the national supervision and management of the quality of medical devices. Above the county level local food and drug supervision and management departments are responsible for the administrative region of the use of medical equipment quality supervision and management.
The higher food and drug supervision and management departments are responsible for guiding and supervising the lower food and drug supervision and management departments to carry out the supervision and management of the quality of medical device use.Article 4 medical devices should be used in accordance with these measures, with its size appropriate medical device quality management organization or quality management personnel, the establishment of quality management covering the whole process of the use of quality management system, the use of medical devices to assume responsibility for the quality of the unit management.
Encourage the use of medical devices to use information technology for the quality management of medical devices.Article 5 medical device production and management of medical equipment sales enterprises shall comply with mandatory standards and registered or filed product technical requirements. Medical device production and management enterprises shall, in accordance with the contract with the use of medical devices, to provide after-sales service of medical devices, guidance and cooperation with the use of medical devices to carry out quality management.
Article 6 medical device use units found to be used in the occurrence of adverse events or suspected adverse events of medical devices, should be in accordance with the relevant provisions of the monitoring of adverse events of medical devices report and deal with.
Chapter II procurement, acceptance and storageArticle 7 Medical devices should be used to implement the unified management of medical device procurement by the designated department or personnel unified procurement of medical devices, other departments or personnel shall not purchase their own.
Article VIII Medical devices should be used from the qualified medical device production and management enterprises to purchase medical devices, request, check the supplier's qualifications, medical device registration certificate or record documents and other supporting documents. Purchased medical devices should be verified product qualification documents, and in accordance with the provisions of the acceptance. Special storage and transportation requirements for medical devices should also verify that the storage and transportation conditions are in line with product specifications and labeling requirements.
Article IX Medical devices should be true, complete and accurate records of purchase inspection. Incoming inspection records should be kept until the expiration of the specified period of use of medical devices 2 years after the expiration or termination of the use of 2 years. Large medical device purchase inspection records should be saved to the expiration of the period of use of medical devices or terminate the use of 5 years; implantable medical devices purchase inspection records should be permanently stored.
Medical devices should be properly preserved to use the original purchase of Class III medical devices, to ensure that the information is traceable.Article 10 medical devices using units to store medical equipment, facilities and conditions should be compatible with the variety and quantity of medical devices, in line with product specifications, labeling requirements and the use of safe and effective needs; temperature, humidity and other environmental conditions have special requirements, but also should monitor and record the storage area of the temperature, humidity and other data. Data.
Article 11 medical devices should be used in accordance with the storage conditions, the expiration date of medical devices and other requirements for the storage of medical equipment for regular inspection and record.
Article XII medical devices shall not be purchased and used in accordance with the law or the record, no qualification documents, as well as expired, expired, out of medical devices.
Chapter III use, maintenance and transferArticle XIII medical devices should be established before the use of medical equipment quality inspection system. Before the use of medical devices, should be checked in accordance with the relevant requirements of the product specification.
Before the use of sterile medical devices, should check the direct contact with the packaging of medical devices and their expiration date. Packaging is damaged, poorly labeled, more than the expiration date or may affect the use of safe and effective, shall not be used.Article XIV medical device use of implantable and interventional medical devices should be established to use the record, implantable medical device use records are kept permanently, the relevant information should be incorporated into the information management system to ensure that the information can be traced.
Article 15 Medical devices should be used to establish a medical device maintenance and repair management system. The need for regular inspection, testing, calibration, maintenance, maintenance of medical devices, should be in accordance with the requirements of the product specification inspection, testing, calibration, maintenance, maintenance and records, timely analysis, evaluation, to ensure that the medical device is in good condition.
The use of large medical devices for a long period of time, should be used to establish a file, record its use, maintenance and so on. Record-keeping period shall not be less than five years after the expiration of the specified period of use of medical devices, or the termination of the use of five years.Article XVI medical devices should be used in accordance with product specifications and other requirements for the use of medical devices. Disposable medical devices shall not be reused, the use of used shall be destroyed in accordance with relevant state regulations and records.
Article XVII Medical devices can be used in accordance with the contractual requirements of the medical device manufacturer to provide medical equipment maintenance and repair services, can also be entrusted to have the conditions and capabilities of the maintenance service organization for the maintenance and repair of medical equipment, or their own in-use medical equipment for maintenance and repair.
Medical devices using units entrusted to the maintenance service organization or their own in-use medical equipment maintenance and repair, medical equipment manufacturers and operators should be in accordance with the contractual agreement to provide maintenance manuals, repair manuals, software backup, fault code list, spare parts list, parts, maintenance passwords and other maintenance and repair of the necessary materials and information.Article 18 by the medical equipment production and management enterprises or maintenance service organizations for the maintenance and repair of medical equipment, should be in the contract agreed to a clear quality requirements, maintenance requirements and other related matters, the use of medical devices should be in each maintenance and repair after the request for and preservation of the relevant records; the use of medical equipment units of their own on the medical device Maintenance and repair of medical devices, should be strengthened to engage in the maintenance and repair of medical equipment, training and assessment of technical personnel, and the establishment of training files.
Article 19 medical device use units found to use the medical device there is a hidden danger, shall immediately stop using, notify the overhaul; by the overhaul still can not meet the use of safety standards, shall not continue to use, and in accordance with the relevant provisions of the disposal.
Article 20 medical devices between the transfer of medical equipment in use, the transferring party shall ensure that the transfer of medical equipment is safe, effective, and provide legal documentation of the product.
The transfer of the two sides shall sign an agreement to transfer the product specification, use and maintenance records file copies and other information, and by a qualified inspection agency inspection before the transfer. The transferee shall refer to the provisions of Article VIII of these measures on the purchase of goods inspection, inspection, meet the requirements before use. shall not be transferred without registration or record, no qualified documents or test failed, as well as expired, invalid, obsolete medical devices.Article 21 medical equipment use units to accept the production and management of medical equipment or other institutions, individuals donate medical equipment, the donor shall provide the relevant legal documents of medical equipment, the recipient shall refer to Article 8 of the Measures on the purchase of goods inspection provisions of the inspection, meet the requirements before use.
shall not be donated without registration or record, no qualified documents or test failed, as well as expired, invalid, out of medical equipment. Medical equipment donated between the use of medical equipment, with reference to Article 20 of these measures on the transfer of medical equipment in use. Chapter IV Supervision and AdministrationArticle 22 Food and Drug Administration in accordance with the principles of risk management, supervision and management of the use of medical equipment quality management.
Municipal food and drug supervision and management departments shall prepare and implement the administrative region of the medical device use unit annual supervision and inspection program to determine the focus of supervision and inspection, frequency and coverage. There is a higher risk of medical devices, special storage and transportation requirements of medical devices and medical devices have a bad credit record of the use of units, should be implemented key supervision. Annual supervision and inspection program and its implementation should be reported to the province, autonomous region, municipality directly under the Central Food and Drug Administration.Article 23 Food and drug supervision and management departments of medical devices to establish and implement the use of medical equipment quality management system for supervision and inspection, supervision and inspection results shall be recorded and incorporated into the supervision and management files.
Food and drug supervision and management of medical equipment use units for supervision and inspection, can be related to the production and operation of medical equipment, maintenance service organizations to extend the inspection. Medical device use units, production and operation of enterprises and maintenance service organizations should cooperate with the food and drug supervision and management departments of the supervision and inspection, and truthfully provide relevant information and data, shall not be refused and concealed.Article 24 medical devices should be used in accordance with these measures and the establishment of the unit of quality management system for the use of medical devices, medical devices each year to carry out a comprehensive self-inspection of the quality of management, and the formation of self-inspection report. Food and drug supervision and management departments in the supervision and inspection of medical equipment use units of the self-inspection report for random checks.
Article 25 food and drug supervision and management departments shall strengthen the use of medical devices sampling test. Food and drug supervision and management departments at the provincial level or above should be based on the conclusions of the sampling and testing, timely release of medical device quality announcement.
Article 26 individuals and organizations found that the use of medical devices in violation of these measures, the right to report to the food and drug supervision and management departments where the use of medical devices. Receive the report of the food and drug supervision and management department shall promptly verify, deal with. After verification, should be in accordance with the relevant provisions of the whistleblower reward.
Chapter V Legal LiabilityArticle 27 medical device use one of the following circumstances, by the food and drug supervision and management departments at or above the county level in accordance with the "Supervision and Administration of Medical Devices Regulations," Article 66 shall be punished:
(a) the use of medical equipment does not meet the mandatory standards or does not meet the registration or record of the product technical requirements. Product technical requirements of medical devices; (B) the use of no qualification documents, expired, expired, out of medical devices, or the use of medical devices not registered according to law.Article 28 medical device use one of the following circumstances, by the food and drug supervision and management departments at or above the county level in accordance with the "Supervision and Administration of Medical Devices Regulations" shall be punished in accordance with the provisions of Article 67:
(a) not in accordance with the requirements of the product specification and labeling of medical devices stored medical devices; (b) Transfer or donation of expired, invalid, obsolete, failed inspection of medical devices in use.Article 29 medical equipment using one of the following circumstances, by the food and drug supervision and management departments at or above the county level in accordance with the "Supervision and Administration of Medical Devices Regulations," the provisions of Article 68 shall be punished:
(a) the failure to establish and implement the system of inspection of incoming medical devices, the failure to check the qualifications of the supplier, or failure to true, complete and accurate records of incoming inspection. Accurately record the purchase inspection; (B) not in accordance with the requirements of the product specification for regular inspection, testing, calibration, maintenance, maintenance and record; (C) found the use of medical devices are not immediately stop using the safety risks, notify the maintenance, or continue to use the maintenance still can not meet the use of safety standards for medical devices; (D) failure to properly save the original purchase of class III medical devices Purchase of Class III medical devices of the original information; (e) not in accordance with the provisions of the establishment and preservation of implantable and interventional medical devices use records.Article 30 medical device use one of the following circumstances, by the food and drug supervision and management department above the county level shall order rectification within a specified period of time, be given a warning; refusal to make corrections, impose a fine of 10,000 yuan:
(a) is not in accordance with the provisions of the medical device quality management organization or quality management personnel commensurate with its size, or is not in accordance with the provisions of the establishment of a quality management system covering the whole process of quality management. In accordance with the provisions of the establishment of quality management covering the whole process of the use of quality management system; (B) not in accordance with the provisions of the designated departments or personnel unified procurement of medical equipment; (C) the purchase and use of the first class of medical devices not filed, or from the record of the purchase of the second class of medical devices from the business enterprise; (D) the storage of medical devices and medical devices, facilities and conditions of the site Species, the number of incompatible, or not in accordance with the storage conditions, the expiration date of medical devices and other requirements for the storage of medical equipment for regular inspection and recording; (e) not in accordance with the provisions of the establishment and implementation of the medical device quality inspection system before use; (f) not in accordance with the provisions of the request for maintenance and repair of medical equipment to save the relevant records; (g) not in accordance with the provisions of the unit engaged in the maintenance and repair of medical equipment related to technical personnel. Medical device maintenance and repair of the relevant technical personnel for training and assessment, the establishment of training files; (h) not in accordance with the provisions of the quality management of its medical devices for self-examination, the formation of self-examination report.Article 31 medical device production and management enterprises in violation of the provisions of Article 17 of these measures, not in accordance with the requirements of the maintenance and repair services, or not in accordance with the requirements of the maintenance and repair of the necessary materials and information, by the food and drug supervision and management departments at or above the county level to give a warning, ordered to make corrections within a specified period of time; the circumstances are serious or refuses to make corrections, a fine of 5000 yuan or more than 20,000 yuan fine.
Article 32 medical device use units, production and operation of enterprises and maintenance services do not cooperate with the food and drug supervision and management supervision and inspection, or refused to, concealment, not truthfully provide the relevant information and data, by the food and drug supervision and management department at or above the county level and ordered to make corrections, be given a warning, and may also impose a fine of 20,000 yuan.
Chapter VI Supplementary ProvisionsArticle 33 for clinical trials of experimental medical devices quality management, in accordance with the relevant provisions of the clinical trials of medical devices.
Article 34 of the use of medical devices in the use of supervision and management, in accordance with the relevant provisions of the National Health and Family Planning Commission.
Article 35 These Measures shall come into force on February 1, 2016 .