(a) in accordance with the "Regulations on the Administration of Medical Institutions", to obtain "medical institutions license" to engage in disease diagnosis, treatment activities of institutions;
(b) in accordance with the "Regulations on the Administration of Family Planning Technical Services", to obtain "family planning technical services institutions license" of the institution;
(C) other institutions in accordance with the law to obtain practicing license and the use of medical devices. Article IV Food and Drug Administration is responsible for the supervision and management of the use of medical devices in the administrative region.
Health, population and family planning, quality and technical supervision and other departments shall, within their respective areas of responsibility, be responsible for the work related to the management of the use of medical devices. Article 5 The use of medical devices should be set up with the unit's business scope and scale of the medical device management organization or full-time management personnel, specifically responsible for the management of the use of medical devices. Article VI medical devices should be used to establish and implement the purchase of medical equipment, acceptance, storage, use, maintenance, sterilization, scrapping, disposal and other management systems. Article 7 The medical device user shall purchase medical devices from enterprises with medical device production and operation qualification. Purchase of medical devices, medical devices should be used to verify the qualifications of the supply unit and product certification. Article VIII of medical devices using units shall establish a medical device purchase file, including:
(a) medical device manufacturer or operator license, a copy of the business license;
(b) the medical device registration certificate (including attachments) and other supporting documents a copy of;
(c) a copy of the registration of the import of medical equipment;
(d) medical device products, products, products and services, medical devices, products and services, medical devices, products and services, medical devices and services. p>(D) medical device product certification;
(E) medical device sales staff unit authorization or power of attorney and its identity.
Provide (a), (b), (c) the information specified in the item, shall be stamped on the copy of the unit providing the seal. Article IX of medical devices using units to purchase medical devices should establish a true and complete purchase and acceptance records to ensure product traceability.
Purchase and acceptance records should include: product name, registration number, specifications, expiration date, manufacturer, supplier, purchase quantity, date of purchase, certificate of conformity, date of manufacture, production batch number, sterilization batch number, acceptance conclusion.
Purchase and acceptance records should be signed or stamped in the acceptance of personnel, save to more than the expiration date of the medical device 2 years; no expiration date, should be saved to not less than 2 years after the termination of the use of medical devices. Article 10 The storage of medical devices shall comply with national standards, industry standards, registered product standards in the relevant provisions. Medical devices should be used in accordance with the product characteristics of medical devices, the implementation of zoning, categorized storage, and equipped with appropriate storage facilities. Article XI of medical devices in the use of medical equipment before the unit shall be put into use, the quality of routine inspection.
Before the use of sterile medical devices, medical devices should be used in direct contact with the medical device packaging and its expiration date for routine inspection, packaging damage, poorly labeled, more than the expiration date or may affect the use of safety, shall not be used. Article XII of the medical equipment for diagnosis and treatment, medical devices should be used in accordance with the relevant provisions of the medical device management testing, repair and use of maintenance, and the establishment of regular testing, repair and use of maintenance records file.
Periodic testing, repair and use of maintenance records include: the use of department, equipment name, equipment number, specifications, manufacturer, start time, testing and repair (use of maintenance) time, testing and repair (use of maintenance) projects, testing and repair (use of maintenance) units, testing and repair (use of maintenance) results and so on. Article XIII of medical devices using units to accept gifts, donations of medical equipment, medical equipment should have a complete product file information, and meet the requirements of medical device product standards. Article XIV of implantable medical devices should be established quality tracking records.
Implantable medical devices, mainly refers to orthopedic internal fixation devices, cardiac pacemakers, intravascular catheters, stents, artificial crystals and so on. Article XV of implantable medical devices quality tracking records include: the use of the department, the patient's basic information and case number, the name of the operation, the operator, the date of the operation, the name of the implanted device, specifications and models, the use of the number of production batch number, sterilized batch number, expiration date, manufacturers, suppliers, certificates of conformity, the serial number of a single product and other necessary information.
Quality tracking records should be filed in the patient's medical records for management. Article XVI strictly prohibit the reuse of implantable medical devices.
Medical device use units should be used in accordance with the provisions of the implantable medical devices for destruction, and record the name of the product, the number of destruction of the time, manner, and implementation of personnel. Article XVII of medical devices using units in the purchase, acceptance, storage, use of unqualified medical devices found in the link, should take appropriate measures to deal with and record, shall not be put into use.