Chapter 1 General Principles
Article 1 In order to strengthen quality supervision and management of medical equipment，Guaranteed safety of medical equipment、Effective，According to the "Regulations on the Supervision and Administration of Medical Devices"，Formation of these measures。
The quality management and supervision and management of medical device in the second use link，It should abide by these Measures。
Article 3 The State Administration of Food and Drug Administration is responsible for the quality supervision and management of national medical device use。Local food and drug supervision and management department at or above the county level is responsible for the quality supervision and management of medical equipment in the administrative area。
superior food and drug supervision and management department is responsible for guiding and supervising lower -level food and drug supervision and management departments to carry out quality supervision and management of medical equipment。
Article 4 The use of medical device use units shall be in accordance with these Measures，Equipped with a medical device quality management agency or quality manager，Establish a quality management system for the entire process of covering quality management，Liability for quality management responsibility for using medical devices in this unit。
Encourage medical device use units to adopt information technology means for medical equipment quality management。
Fifth medical device sold stake sports betting appby medical device production and operation enterprises shall meet the compulsory standards and registered or recorded product technical requirements。Medical equipment production and operation enterprises shall be agreed in accordance with the contract with medical equipment use units，Provide medical device after -sales service，Guide and cooperate with the use of medical equipment use units to carry out quality management work。
Article 6 of the medical device use unit found that the medical device used in the medical device occurred in bad events or suspicious adverse events，It shall be reported and handled in accordance with the relevant provisions of the adverse event monitoring of medical equipment。
Chapter 2 Procurement, Acceptance and Storage
Seventh -medical equipment use unit shall implement unified management of medical device procurement，Uniformly purchased medical equipment from the designated department or personnel，Other departments or personnel may not purchase。
Article 8 Medical Device User Units shall purchase medical equipment from qualified medical device production and operation enterprises，Consumers、Check the qualification of supplier、Certificate documents such as medical device registration certificates or filing vouchers。The medical device purchased should be verified the product qualification certificate，and accept in accordance with regulations。For medical devices with special storage and transportation requirements, they should also verify whether the storage and transportation conditions meet the requirements of the product manual and label。
Article 9 of the medical device use unit shall be true、Full、Record the purchase inspection stake betting appsituation accurately。Purchase inspection records should be stored until the stipulated period of the medical device should be 2 years after the expiration of the period of use or 2 years after use.。Inspection records of large -scale medical device purchase should be stored to 5 years after the expiration of the period of use in the medical device or 5 years after use;。
Medical equipment use units should properly preserve the original information of purchasing the third type of medical equipment，Make sure the information is traceable。
Article 10 The place where medical device use units store medical equipment、Facilities and conditions shall be with the variety of medical equipment、Similar to the quantity，Follow the product manual、The requirements of the label and use safety、Effective needs; for temperature、Special requirements for environmental conditions such as humidity，It should also monitor and record the temperature in the storage area、Data such as humidity。
Article 11 The use of medical device use units shall be in accordance with the storage conditions、The validity period of medical equipment is required to conduct regular inspections and records the stored medical equipment。
Article 12 of the use of medical device use units shall not purchase or use unpaid registration or filing in accordance with the law、No qualified certification documents and expired、Lise、Medical equipment eliminated。
Chapter 3 Use, Maintenance and Transfer
Article 13 The use of medical device use units shall establish a quality inspection system before use of medical equipment。Before using medical equipment，Check it in accordance with the relevant requirements of the product manual。
Before using sterile medical equipment，It should be checked to directly contact the packaging of medical devices and its validity period。Packaging damage、Label is unclear、Excellent period of validity or may affect the use of safety、Effective，Do not use。
Article 14 The use of medical device use units shall establish a record and use records for implantation and intervention medical devices，Permanent preservation of implant medical equipment，Related information should be included in the information management system，Make sure the information can be traceable。
Article 15 The use of medical device use units shall establish a medical device maintenance and maintenance management system。For regular inspections、Test、Calibration、Maintenance、Maintenance medical equipment，Check it in accordance with the requirements of the product manual、Test、Calibration、Maintenance、Maintenance and record，Make analysis in time、Evaluation，Make sure that medical equipment is in a good state。
Large medical equipment with long period of use，Should be established on the stage，Record its use、Maintenance, etc.。Record preservation period must not be less than 5 years after the expiration of the period after the use of medical devices or 5 years after use.。
Article 16 Medical Device User Units shall use medical devices in accordance with product manuals, etc.。Disposable medical devices shall not be reused，For those who have used it, they should be destroyed and recorded in accordance with relevant national regulations。
Article 17 Medical Device User Units can provide medical device maintenance and maintenance services in accordance with the contract of the contract，You can also entrust conditional and capable maintenance service agencies for medical device maintenance and maintenance，or maintenance and maintenance of the use of medical devices by yourself。
The maintenance service agency entrusted by the medical device use unit or the maintenance and maintenance of the use of medical equipment，Medical equipment production and operation enterprises shall provide a maintenance manual in accordance with the contract、Maintenance manual、Software backup、Fault code table、Spare parts list、Parts、Maintenance passwords and other materials and information necessary for maintenance and maintenance。
Article 18 shall be maintained stake sports betting appby medical device production and operation enterprises or maintenance service agencies to maintain and repair medical devices，The clear quality requirements shall be agreed in the contract、Maintenance requirements and other related matters，Medical equipment use units shall ask for and save relevant records after each maintenance;，The training and assessment of technical personnel engaged in medical device maintenance should be strengthened，Create a training file。
Article 19 The medical device used by the medical device use unit has hidden safety hazards，It should be stopped immediately，Notification for maintenance; the inspection still cannot meet the safety standards，Do not continue to use，and deal with it in accordance with relevant regulations。
Article 20 Medical Devices Used Units are transferred to use medical equipment，The transferor shall ensure the safety of the transferred medical equipment、Effective，and provide legal certification documents。
Transfer parties should sign an agreement，Transfer product manual、Use and repair record file copy and other information，and can be transferred after passing the qualified inspection agency for inspection。The transferee shall be checked by referring to Article 8 of these Measures on the regulations on purchase inspection，It can be used after meeting the requirements。
Do not transfer or not be registered or filed in accordance with the law、No qualified certification documents or not qualified inspection，and expired、Lise、Medical equipment eliminated。
Article 21 of the use of medical device use units to receive medical equipment production and operation enterprises or other institutions、Personal donation of medical equipment，Donor should provide relevant legal certification documents for medical devices，The gift should be checked with reference to Article 8 of these Measures on the regulations on purchase inspection，It can be used after meeting the requirements。
Do not donate or not to register or file in accordance with the law、No qualified certification documents or not qualified inspection，and expired、Lise、Medical equipment eliminated。
Donation of medical equipment for medical equipment，Refer to Article 20 of these Measures on the Regulations on Transfer of Medical Device。
Chapter 4 Supervision and Management
Article 22 The food and drug supervision and management department shall be in accordance with the principle of risk management，Supervision and management of the quality of medical equipment in the use link。
Municipal food and drug supervision and management departments of the district shall compile and implement the annual supervision and inspection plan of medical device use units in the administrative area，Determine the focus of supervision and inspection、frequency and coverage。For medical equipment with higher risks、Medical devices with special storage and transportation requirements, and medical device use units with bad credit records，Key supervision should be implemented。
Annual Supervision and Inspection Plan and its implementation situation shall be reported to the province、Autonomous Region、Food and Drug Supervision and Management Department of Municipality directly under the Central Government。
Article 23 Food and Drug Supervision and Administration Department Establishment of Medical Devices Usage、The quality management system of the medical device uses the quality management system for supervision and inspection，The results of the supervision and inspection should be recorded，Integrated into the supervision and management file。
Food and Drug Supervision and Management Department When supervising and inspecting medical equipment use units，It can be produced and operated by related medical equipment、Maintenance service agency, etc.。
Medical Device Usage Unit、Production and operation enterprises and maintenance service agencies shall cooperate with the supervision and inspection of the food and drug supervision and management department，Provide relevant situations and information truthfully，Do not refuse and conceal。
Article 24 The use of medical device use units shall be based on the quality management system of medical device use established by the unit，Make a comprehensive self stake betting app-examination of the quality management of medical equipment every year，and form a self -examination report。Food and Drug Supervision and Administration Department in the supervision and inspection of self -examination reports of medical equipment use units。
Article 25 of the food and drug supervision and management department shall strengthen the spot check and inspection of medical devices in the use of links。Food and drug supervision and management departments above the provincial level shall be based on the random inspection inspection conclusion，Publish medical equipment quality announcement in time。
Article 26 Individuals and organizations discover that medical equipment use units violate the behavior of these measures，It has the right to report to the food and drug supervision and management department where the medical equipment use unit is located。The food and drug supervision and management department received by the report shall verify it in time、Treatment。verified that it is true，Reward the reporter shall be rewarded in accordance with relevant regulations。
Chapter 5 Legal Responsibility
Article 27 The use of medical device use units have one of the following situations，The food and drug supervision and management departments at or above the county level are punished in accordance with Article 66 of the Regulations on the Supervision and Administration of Medical Device:
(1) Use medical devices that do not meet the compulsory standards or do not meet the registered or filed product technical requirements;
(2) Use without qualified certification files、Expired、Lise、Medical equipment eliminated，or using medical devices that have not been registered in accordance with the law。
Article 28 of the use unit of medical equipment has one of the following situations,The food and drug supervision and management departments at or above the county level are punished in accordance with Article 67 of the Regulations on the Supervision and Administration of Medical Devices:
(1) Those who have not stood in accordance with the instructions and labels of medical device products and labels;
(2) Transfer or donation expires、Lise、Removal、Test the unqualified medical equipment。
Article 29 of the medical equipment use unit has one of the following situations，The food and drug supervision and management departments at or above the county level are punished in accordance with Article 68 of the Regulations on the Supervision and Administration of Medical Device:
(1) The inspection system that has not been established and implements medical device purchase，Qualification of the supplier without checking the supplier，or not real、Full、Record the purchase checking situation accurately;
(2) Do not conduct regular inspections in accordance with the requirements of the product manual、Test、Calibration、Maintenance、Maintenance and record;
(3) It is found that there are hidden safety hazards used in the use、Notification Maintenance，or continuing to use medical devices that can still not meet the use of safety standards;
(4) The original information of the third category of medical devices is not properly preserved;
(5) Failure to establish and preserve the recording of the use of implantation and intervention medical equipment in accordance with regulations。
Article 30 The use of medical equipment use units have one of the following situations，Food and drug supervision and management department at or above the county level ordered to correct the time limit，Give warning;，Fined fines below 10,000 yuan:
(1) Failure to equip medical device quality management institutions or quality management personnel，or the quality management system that has not established the entire process of quality management in accordance with regulations;
(2) If the designated department or personnel are uniformly purchased by the designated department or personnel in accordance with the regulations;
(3) Buy、Using the first type of medical device with unpacking the record，or an unpatling business enterprise purchase the second type of medical equipment;
(4) Place of storage of medical devices、Facilities and conditions and medical device varieties、The quantity is not suitable，or not according to the storage conditions、The validity period of medical device is required to conduct regular inspections and records of medical devices stored;
(5) Failure to establish it in accordance with regulations、The quality inspection system before use of medical equipment;
(6) Failure to obtain it in accordance with regulations、Preserving medical device maintenance and maintenance related records;
(7) No training and assessment of relevant technical personnel who are engaged in medical device maintenance and maintenance in accordance with regulations、The training file is established;
(8) No self stake betting app-examination of the quality management of medical equipment in accordance with regulations、Forming a self -examination report。
Article 31 of the production and operation enterprises of medical device violations of Article 17 of these Measures，No maintenance and maintenance service is not provided as required，or the materials and information necessary for maintenance and maintenance as required，Alert by the food and drug supervision and management department at or above the county level，Order to correct correction within a time limit; serious or refusal to correct，Fined fines of 5,000 yuan and 20,000 yuan。
Article 32 User Unit for Medical Devices、Production and operation enterprises and maintenance service agencies, etc.，or refuse、concealment、It is better to provide relevant situations and information，The food and drug supervision and management department at or above the county level is ordered to make corrections，Give warning，It can be fined below 20,000 yuan。
Chapter 6 Attachment
Article 33 The quality management of test medical devices used for clinical trials，Implement in accordance with the relevant regulations of the medical device clinical trials。
34 Supervision and Management of the use of medical devices in the use link，Implement in accordance with the relevant provisions of the National Health and Family Planning Commission。
Article 35 This Measures will be implemented from February 1, 2016。
