Article XVIII of the medical device business enterprises and the use of units should be from the legal qualifications of medical equipment production and operation of enterprises to purchase medical devices.
Medical equipment business enterprises shall not operate unregistered, no proof of conformity, expired, invalid or obsolete medical devices. Medical devices shall not use the use of unregistered, no proof of conformity, expired, invalid or obsolete medical devices.
Article 19 of the medical device business enterprises and the use of medical devices purchased by the unit, should be requested, retain sales vouchers and related information required by the state; for the first time to the supply of units, but also should be requested to file the following information stamped with the seal of the supplying unit:
(a) "Medical Device Manufacturer's License" or "Medical Device Operator's License" and the business license Copies of the production and operation of medical devices belonging to the "Medical Device Classification Catalog" in the first class of medical devices, only need to obtain a copy of the business license;
(b) medical device registration certificate and "medical device registration form" copy;
(c) the supply unit of medical equipment sales power of attorney;
(d) a copy of the valid identity of the sales staff.
Medical equipment business enterprises and the use of units in accordance with the provisions of the preceding paragraph of this article retained sales vouchers and information should be preserved until more than the expiration date of the medical device or the use of 1 year, but shall not be less than 2 years.
Article 20 of the medical device business enterprises and the use of units to purchase medical devices, shall establish and implement the purchase inspection and acceptance system, inspection of medical devices and other identification; does not meet the prescribed requirements, shall not be purchased.
Medical equipment business enterprises and the use of units purchasing medical devices must have a true and complete procurement and acceptance records, procurement and acceptance records should be confirmed by the signature of the acceptance of personnel.
Article 21 of the medical device manufacturer sales of medical devices should be issued marked with the name of the purchasing unit, the name of the medical device, product registration number, specifications, quantity, price, manufacturer, production batch number or product number of the content of the sales voucher, and stamped.
Medical equipment business enterprises selling "Medical Device Classification Catalog" in the second and third class of medical devices, should be issued to indicate the name of the purchasing unit, the name of the medical device, product registration number, specifications, quantity, price, manufacturer, production batch number or product number of the content of the sales voucher and stamped.
Medical device manufacturers, operators of medical devices sales of medical devices must have a true and complete sales records.
Article 22 of the purchase and acceptance of medical devices, sales records, should indicate the name of the medical device, specifications, production batch number or product number, expiration date, manufacturer, date of manufacture, product registration number, purchase and sale of units, purchase and sale of quantities, purchase and sale price, purchase and sale date and other content. Sterile medical devices must indicate the date of sterilization, sterilization lot number.
Medical device purchase and acceptance, sales records should be saved to more than the product expiration date or use 1 year, but not less than 2 years; one-time use of sterile medical devices, purchase and acceptance, sales records should be saved to more than the product expiration date of 2 years; implantable medical devices, purchase and acceptance, sales records should be permanently stored.
Article 23 of the medical device production, operation and use of enterprises should be in accordance with product standards and instructions for the storage and transportation of medical devices, and the establishment of medical device maintenance records.
Medical device production, operation and use of enterprises can be entrusted to have to ensure the quality and safety of medical devices, storage and transportation of products.
Article 24 The use of medical devices shall have the following conditions before the use of medical devices for diagnosis and treatment and other acts:
(a) a sound management system for the use of medical devices;
(b) in line with the requirements of the performance of medical devices place, facilities, equipment and sanitation;
(c) with the use of medical devices compatible with the technical staff
(D) laws and regulations of other conditions.
Article 25 of the medical device use units using implantable medical devices, shall establish and permanently save the following records of use:
(a) the patient's name, gender, age, address, mailing address, contact phone number, medical record number, surgery time, surgeon;
(b) the product name, registration number, product number, specification number, production date, Production batch number, expiration date;
(C) the name of the manufacturer, registered address, production address, manufacturer's license number;
(D) the name of the supply unit and its license number.
Patients requesting the use of the previous paragraph of the record, the use of medical devices should be provided.