Medical device use quality supervision and management measures since when it came into force

Chapter I General

Article I in order to strengthen the supervision and management of the quality of medical devices to ensure that the use of medical devices, safe and effective, according to the "supervision and management of medical devices regulations", the development of this approach.

Article II of the use of medical equipment quality management and supervision and management, shall comply with these measures.

Article III of the State Food and Drug Administration is responsible for the national supervision and management of the use of medical equipment quality. Above the county level, the 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 supervision and management of the quality of medical devices.

Article 4 The use of medical devices should be 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 management of the unit.

Encourage the use of medical devices to use information technology for the quality management of medical devices.

Article V medical device production and management of sales of medical devices should be in line with mandatory standards and registered or filed by the technical requirements of the product. Medical device production and management enterprises should be in accordance with the contract with the use of medical devices, medical devices to provide after-sales service, guidance and cooperation with the use of medical devices to carry out quality management.

Article 6 of the use of medical devices found in the use of medical devices adverse events or suspected adverse events, should be in accordance with the relevant provisions of the monitoring of adverse events of medical devices reported and processed.

Chapter II procurement, acceptance and storage

Article 7 of the medical device user should be unified management of medical device procurement, by its designated departments or personnel unified procurement of medical equipment, other departments or personnel shall not purchase their own.

Article VIII of medical devices should be used from the qualified medical equipment production and management enterprises to purchase medical devices, request, check the qualifications of the supplier, 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 of 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 after 2 years or 2 years after the termination of use. Large medical device purchase inspection records should be kept until the expiration of the specified period of use of medical equipment 5 years after the expiration or termination of the use of 5 years; implantable medical devices purchase inspection records should be permanently stored.

Medical devices using units should be properly preserved purchase of Class III medical devices of the original information to ensure that the information is traceable.

Article 10 of the medical device 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; on the temperature, humidity and other environmental conditions have special requirements, but also should be monitored and recorded in the storage area of the temperature, humidity and other data.

Article XI of 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 of medical devices shall not be purchased and used in the use of medical equipment is not registered or filed according to law, no qualified documents and expired, expired, out of medical equipment.

Chapter III use, maintenance and transfer

Article XIII of 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 14 of the use of medical devices on implantable and interventional medical devices should be established to use records, implantable medical devices to use records of permanent preservation, the relevant information should be incorporated into the information management system to ensure that the information can be traced.

Article 15 of the medical device user shall establish a medical device maintenance and repair management system. The need for regular inspection, inspection, calibration, maintenance, maintenance of medical devices, should be in accordance with the requirements of the product specification inspection, inspection, 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 of 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 the past should be destroyed in accordance with relevant state regulations and records.

Article XVII of medical devices can be used in accordance with the contractual requirements of medical equipment manufacturers and operators to provide medical equipment maintenance and repair services, but also can be entrusted with the conditions and capabilities of the maintenance service organizations to maintain and repair medical equipment, or their own in-use medical equipment maintenance and repair.

Medical devices using units entrusted to the maintenance service organizations 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 of the medical device production and management enterprises or maintenance service organizations for the maintenance and repair of medical equipment, should be agreed in the contract clear quality requirements, maintenance requirements and other related matters, the use of medical devices should be in each maintenance and repair after requesting and preserving the relevant records; the use of medical devices on their own maintenance and repair of medical devices should be strengthened to engage in the maintenance and repair of medical equipment technical personnel training and assessment. Maintenance and repair of medical devices should be strengthened to engage in the maintenance and repair of technical personnel training and assessment, and the establishment of training files.

Article 19 of the use of medical equipment found in the use of medical devices have hidden safety problems, should immediately stop using, notify the maintenance; by the maintenance 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 of the medical equipment between the use of medical devices in the transfer of medical equipment, 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 should 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 The use of medical equipment units to accept the production and management of medical equipment or other organizations, individuals donate medical equipment, the donor shall provide the relevant legal documents of medical equipment, the recipient shall refer to the provisions of Article 8 on the purchase of goods inspection, inspection, meet the requirements before use.

shall not be donated not registered or filed according to law, no qualified documents or test failed, as well as expired, invalid, out of medical equipment.

Medical devices 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 Administration

Article 22 of the Food and Drug Administration in accordance with the principles of risk management, the use of medical equipment quality supervision and management.

Municipal food and drug supervision and management departments should be prepared and implemented in the administrative region of the use of medical devices 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 provincial, autonomous regions and municipalities directly under the Central Food and Drug Administration.

Article 23 of the food and drug supervision and management departments on the use of medical equipment units to establish and implement the use of medical equipment quality management system for supervision and inspection, supervision and inspection results should 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 users, production and management 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 rejected and concealed.

Article 24 The use of medical devices should be in accordance with these measures and the establishment of the unit of medical device quality management system, the annual quality management of medical devices to carry out a comprehensive self-examination, and the formation of self-examination 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 The food and drug supervision and management departments shall strengthen the use of medical equipment 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, and timely release of medical device quality announcements.

Article 26 individuals and organizations found that the use of medical devices in violation of these measures, the right to use medical devices to the local food and drug supervision and management departments to report. Received the report of the food and drug supervision and management departments shall promptly verify, deal with. After verification, shall be in accordance with the relevant provisions of the whistleblower reward.

Chapter V Legal Liability

Article 27 of the use of medical devices, 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 66 shall be punished:

(a) the use of medical devices does not meet the mandatory standards or does not meet the technical requirements of the registered or filed products;

(b) (ii) the use of non-conforming documents, expired, the use of medical devices; and The use of non-conforming documents, expired, expired, out of medical devices, or the use of medical devices not registered according to law.

Article 28 The use of medical devices, 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 management of medical equipment regulations" shall be punished in accordance with the provisions of Article 67:

(a) not in accordance with the product specification and labeling requirements for the storage of medical devices;

(b) the transfer or donation of expired, expired, eliminated, failed inspection Medical devices in use.

Article 29 The use of medical equipment in 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 management of medical equipment regulations" shall be punished in accordance with the provisions of Article 68:

(a) the failure to establish and implement the system of purchase and inspection of medical equipment, the failure to check the qualifications of the supplier, or not a true, complete, and accurate record of the purchase of the inspection situation;

(b) not in accordance with the instructions of the product storage requirements;

(ii) the transfer or donation of expired, obsolete, unqualified for testing in the use of medical equipment. (Not in accordance with the requirements of the product specification for regular inspection, testing, calibration, maintenance, maintenance and record;

(C) found that the use of medical devices are not immediately stop the use of safety hazards, notification of maintenance, or continue to use the maintenance can not meet the use of safety standards for medical devices;

(D) not properly preserved the purchase of Class III medical devices, the original information;

(C) not to establish a system of inspection and testing of medical devices, or not true, complete and accurate records of the purchase inspection;

( (E) not in accordance with the provisions of the establishment and preservation of implanted and interventional medical devices use records.

Article 30 of the medical device use one of the following circumstances, by the food and drug supervision and management departments at or above the county level ordered to make corrections within a specified period of time, be given a warning; refused 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 the whole process of quality management covering the use of quality management system;

(b) the use of medical devices to ensure that the medical devices used by the medical device manufacturers are in accordance with the requirements of the medical device manufacturer. 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 Class I medical devices are not filed, or not filed for the purchase of Class II medical devices from the business enterprise;

(D) the storage of medical devices and medical equipment, facilities and conditions of the place, the number of varieties, or in accordance with the requirements of the storage conditions, the expiration date of medical devices. Medical devices, the expiration date and other requirements for the storage of medical devices for regular inspection and record;

(E) not according to the provisions of the establishment and implementation of medical equipment before use quality inspection system;

(F) not according to the provisions of the request, save the medical equipment maintenance and repair records;

(G) not according to the provisions of the unit engaged in the maintenance and repair of medical devices related to the training and assessment of technicians, the establishment of training files;

(G) not according to the provisions of the maintenance and repair of medical equipment related to the training and assessment of technicians, the establishment of training files;

(H) not according to the provisions of the medical equipment maintenance and repair of medical devices related to the training and assessment of medical devices;

Article 31 of the medical device production and management enterprises in violation of the provisions of Article XVII of these measures, failure to provide maintenance and repair services, or failure to provide maintenance and repair of materials and information necessary, 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 refused to make corrections, impose a fine of 5,000 yuan of 20,000 yuan or less.

Article 32 The use of medical devices, production and operation of enterprises and maintenance service organizations do not cooperate with the food and drug supervision and management supervision and inspection, or refused, concealed, not truthfully provide relevant information and data, by the food and drug supervision and management departments above the county level shall order correction, give a warning, and may impose a fine of 20,000 yuan.

Chapter VI Supplementary Provisions

Article 33 of the clinical trials for the test of 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 of behavior, in accordance with the relevant provisions of the National Health and Family Planning Commission.

Article 35 of these measures since February 1, 2016 shall come into force.