The latest "medical device use quality supervision and management approach"

Order of the State Food and Drug Administration
 

No. 18
 

The Measures for the Supervision and Administration of the Use Quality of Medical Devices, as deliberated and adopted at the executive meeting of the State Food and Drug Administration on September 29, 2015, are hereby issued, and shall come into force on February 1, 2016.
 

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

 

Chapter I General Provisions
 

Article 1 In order to strengthen the supervision and administration of the use quality of medical devices and ensure the safe and effective use of medical devices, these Measures are formulated in accordance with the Regulations on the Supervision and Administration of Medical Devices.
 

Article 2 The quality management and supervision and administration of medical devices in the use link shall abide by these Measures.
 

Article 3 The State Food and Drug Administration shall be responsible for the supervision and administration of the use quality of medical devices throughout the country. The local food and drug supervision and 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 areas.
 

The food and drug supervision and administration department at a higher level shall be responsible for guiding and supervising the food and drug supervision and administration department at a lower level to carry out the supervision and administration of the use quality of medical devices.
 

Article 4 Medical device users shall, in accordance with these Measures, 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 assume the quality management responsibility for the use of medical devices in their own units.
 

Encourage medical device users to use information technology means for medical device quality management.
 

Article 5 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.

 

Article 6 If a medical device user finds that an adverse event or suspicious adverse event occurs in the medical device used, it shall report and handle it in accordance with the relevant provisions on the monitoring of adverse events of medical devices.
 

 

Chapter II Procurement, Acceptance and Storage
 

Article 7 Medical device users shall implement unified management of medical device procurement, and the departments or personnel designated by them shall purchase medical devices in a unified manner, and other departments or personnel shall not purchase by themselves.
 

Article 8 Medical device users shall purchase medical devices from qualified medical device production and operation enterprises, and obtain and check the supplier's qualification, medical device registration certificate or filing certificate and other supporting documents. The purchased medical devices shall verify the product qualification certification documents and carry out acceptance according to regulations. For medical devices with special storage and transportation requirements, it should also be verified whether the storage and transportation conditions meet the requirements of the product instructions and labels.
 

Article 9 A medical device user shall record the inspection of incoming goods in a true, complete and accurate manner. The incoming inspection records shall be kept until 2 years after the expiration of the prescribed period of use of the medical device or 2 years after the termination of use. The incoming inspection records of large medical devices shall be kept until 5 years after the expiration of the prescribed period of use of medical devices or 5 years after the termination of use; the incoming inspection records of implantable medical devices shall be kept permanently.
 

The medical device user shall properly preserve the original data on the purchase of Class III medical devices to ensure that the information is traceable.
 

Article 10 The places, facilities and conditions for storing medical devices by medical device users shall be compatible with the types and quantities of medical devices, meet the requirements of product specifications and labels, and meet the needs of safe and effective use; environmental conditions such as temperature and humidity If there are special requirements, the temperature, humidity and other data of the storage area shall also be monitored and recorded.
 

Article 11 The user of medical devices shall regularly inspect and record the stored medical devices in accordance with the storage conditions, validity period of medical devices and other requirements.
 

Article 12 Medical device users shall not purchase and use medical devices that have not been registered or filed in accordance with the law, have no qualified certification documents, and are expired, invalid, or eliminated.

 

Chapter III Use, Maintenance and Transfer
 

Article 13 A medical device user shall establish a pre-use quality inspection system for medical devices. Before the use of medical devices, should be checked in accordance with the relevant requirements of the product instructions.
 

Before using sterile medical devices, the packaging of direct contact medical devices and their validity period should be checked. If the package is damaged, the mark is not clear, the validity period is exceeded or may affect the safety and effectiveness of use, it shall not be used.
 

Article 14 Medical device users shall establish use records for implantable and interventional medical devices, and the use records of implantable medical devices shall be kept permanently, and relevant information shall be incorporated into the information management system to ensure that the information is traceable.
 

Article 15 A medical device user shall establish a medical device maintenance and repair management system. Medical devices that require regular inspection, inspection, calibration, maintenance, and maintenance shall be inspected, inspected, calibrated, maintained, and recorded in accordance with the requirements of the product manual, and analyzed and evaluated in a timely manner to ensure that the medical devices are in good condition.
 

For large medical devices with long service life, the use files shall be established one by one to record their use and maintenance. The record retention period shall not be less than 5 years after the expiration of the prescribed period of use of medical devices or 5 years after the termination of use.
 

Article 16 Medical device users shall use medical devices in accordance with the requirements of product specifications. Disposable medical devices shall not be reused, and those used shall be destroyed and recorded in accordance with the relevant provisions of the State.
 

Article 17 A medical device user may, in accordance with the contract, require the medical device production and operation enterprise to provide medical device maintenance and repair services, or may entrust a qualified and capable maintenance service institution to carry out medical device maintenance and repair, or carry out maintenance and repair of medical devices in use by itself.
 

If the medical device user entrusts a maintenance service organization or carries out maintenance and repair on the medical devices in use by itself, the medical device production and operation enterprise shall provide maintenance manual, maintenance manual, software backup, fault code list, spare parts list, spare parts, maintenance password and other necessary materials and information for maintenance and repair in accordance with the contract.
 

Article 18 If a medical device manufacturing and operating enterprise or a maintenance service organization carries out maintenance and repair of medical devices, it shall stipulate clear quality requirements, maintenance requirements and other related matters in the contract. The medical device user shall obtain and keep relevant records after each maintenance and repair. If the medical device user carries out maintenance and repair of medical devices on its own, it shall strengthen the training and assessment of technicians engaged in medical device maintenance and repair, and create training files.
 

Article 19 If a medical device user finds that the medical device in use has potential safety hazards, it shall immediately stop using it and notify it for maintenance; if it still fails to meet the safety standards for use after maintenance, it shall not continue to use it and dispose of it in accordance with relevant regulations.
 

Article 20 In the transfer of medical devices in use between medical device users, the transferor shall ensure that the transferred medical devices are safe and effective, and provide legal certification documents for the products.
 

The two parties to the transfer shall sign an agreement, hand over the product description, copies of the use and maintenance records 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.

 

Medical devices that have not been registered or filed in accordance with the law, have no qualified certification documents or fail to pass the inspection, and are expired, invalid or eliminated shall not be transferred.
 

Article 21 Where a medical device user accepts medical device donations from medical device production and operation enterprises or other institutions or individuals, the donor shall provide relevant legal certification documents of the medical device, and the recipient shall refer to Article 8 of these Measures on purchase inspection The provisions of the inspection shall be inspected and used only after meeting the requirements.
 

It is not allowed to donate medical devices that are not registered or filed in accordance with the law, have no qualified certification documents or fail to pass the inspection, and are expired, invalid, or eliminated.
 

The donation of medical devices in use between medical device users shall be handled with reference to the provisions of Article 20 of these Measures on the transfer of medical devices in use.

 

Chapter IV Supervision and Administration
 

Article 22 The food and drug supervision and administration department shall, in accordance with the principle of risk management, supervise and manage the quality of medical devices in the use link.
 

The food and drug supervision and administration department at the municipal level divided into districts shall prepare and implement the annual supervision and inspection plan of the medical device users in their respective administrative regions, and determine the focus, frequency and coverage of supervision and inspection. For medical devices with high risks, medical devices with special storage and transportation requirements, and medical device users with bad credit records, key supervision should be implemented.
 

The annual supervision and inspection plan and its implementation shall be reported to the food and drug supervision and administration departments of the provinces, autonomous regions and municipalities directly under the Central Government.
 

Article 23 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 supervision and inspection and include them in the supervision and management files.
 

When the food and drug supervision and administration department supervises and inspects the medical device users, it may conduct extended inspections on the relevant medical device production and operation enterprises, maintenance service institutions, etc.
 

Medical device users, production and operation enterprises and maintenance service institutions shall cooperate with the supervision and inspection of the food and drug supervision and administration department, truthfully provide relevant information and materials, and shall not refuse or conceal them.

 

Article 24 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.

 

Article 25 The food and drug regulatory department shall 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.
 

Article 26 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 deal with it in a timely manner. If it is verified to be true, the informant shall be rewarded in accordance with the relevant provisions.

 

Chapter V Legal Liability
 

Article 27 If a medical device user has any of the following circumstances, the food and drug supervision and administration department at or above the county level shall punish it in accordance with the provisions of Article 66 of the Regulations on the Supervision and Administration of Medical Devices:
 

(I) the use of medical devices that do not meet the mandatory standards or do not meet the technical requirements of registered or filed products;
 

(II) the use of non-qualified documents, expired, invalid, obsolete medical devices, or the use of medical devices not registered in accordance with the law.
 

Twenty-eighth medical device users have one of the following circumstances, by the food and drug supervision and administration departments at or above the county level in accordance with the "medical device supervision and administration regulations" article sixty-seventh of the provisions of punishment:
 

The (I) fails to store the medical device in accordance with the product specification and labeling requirements of the medical device;
 

(II) transfer or donation of expired, invalid, eliminated, unqualified in-use medical devices.
 

Article 29 If a medical device user has any of the following circumstances, the food and drug supervision and administration department at or above the county level shall be punished in accordance with the provisions of Article 68 of the Regulations on the Supervision and Administration of Medical Devices:
 

The (I) fails to establish and implement the medical device purchase inspection system, fails to check the qualification of the supplier, or fails to truly, completely and accurately record the purchase inspection situation;
 

The (II) fails to carry out regular inspection, inspection, calibration, maintenance, maintenance and record according to the requirements of the product specification;
 

If the (III) finds that the medical devices in use have potential safety hazards and fails to stop using them immediately, notify them for maintenance, or continue to use the medical devices that cannot meet the safety standards after maintenance;
 

The (IV) fails to properly preserve the original data on the purchase of Class III medical devices;
 

(V) failure to establish and preserve the use records of implanted and interventional medical devices as required.
 

Article 30 If a medical device user has one of the following circumstances, the food and drug regulatory department at or above the county level shall order it to make corrections within a time limit and give a warning; if it refuses to make corrections, it shall be fined less than 10000 yuan:
 

The (I) is not equipped with medical device quality management institutions or quality management personnel suitable for its scale, or fails to establish a use quality management system covering the whole process of quality management;
 

(II) fails to purchase medical devices uniformly by the designated department or personnel as required;
 

(III) the purchase and use of the first category of medical devices that have not been filed, or the purchase of the second category of medical devices by operating enterprises that have not been filed;
 

(IV) the place, facilities and conditions for the storage of medical devices are not compatible with the variety and quantity of medical devices, or the stored medical devices are not regularly inspected and recorded in accordance with the storage conditions, medical device validity period and other requirements;
 

The (V) fails to establish and implement the pre-use quality inspection system for medical devices;
 

The (VI) fails to obtain and keep relevant records of medical device maintenance and repair as required;
 

The (VII) fails to train and assess the relevant technical personnel of the unit engaged in the maintenance and repair of medical devices and establish training files in accordance with the regulations;
 

The (VIII) fails to conduct self-examination and form a self-examination report on the quality management of its medical devices in accordance with the regulations.
 

Article 31 If a medical device production and operation enterprise violates the provisions of Article 17 of these Measures by failing to provide maintenance and repair services as required, or failing to provide materials and information necessary for maintenance and repair as required, the food and drug supervision and administration at or above the county level The department gave a warning and ordered corrections within a time limit; if the circumstances are serious or refuse to make corrections, a fine of 5000 yuan up to 20000 yuan shall be imposed.
 

Article 32 If medical device users, production and operation enterprises and maintenance service institutions do not cooperate with the supervision and inspection of the food and drug regulatory department, or refuse, conceal or fail to provide relevant information and materials truthfully, the food and drug supervision and administration department at or above the county level shall order them to make corrections, give them a warning and may concurrently impose a fine of less than 20000 yuan.

 

Chapter VI Supplementary Provisions
 

Article 33 The quality management of medical devices for clinical trials shall be carried out in accordance with the relevant provisions on clinical trials of medical devices.
 

Article 34 The supervision and administration of the use of medical devices in the use process shall be implemented in accordance with the relevant provisions of the National Health and Family Planning Commission.

 

Article 35 These Measures shall come into force as of February 1, 2016.