Article XVIII of the medical device production and operation of medical equipment sales enterprises, should be issued to indicate the name of the purchasing unit, the name of the medical device, the product registration number, specifications, quantity, price, manufacturer, production batch number or product number and other content of the sales voucher, and stamped with a seal.
Article 19 of the medical device business 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 its supply of units, but also should be requested to file the following information stamped with a unit seal:
(a) medical device manufacturer's license or medical device business license and a copy of the business license;
(b) the medical device manufacturer's license or medical device business license and a copy of the business license;
(b) medical device registration certificate and a copy of the medical device registration form;
(c) the supplier of medical equipment sales power of attorney;
(d) a copy of the salesperson's valid identification.
The transfer of medical devices between medical institutions should provide the transferee with the manufacturer or the statutory body issued by the transfer of the test certificate and the relevant information specified by the state.
Article 20 of the medical device business and the use of medical equipment purchasing units should establish the purchase inspection and acceptance system, check the supplier's production or business qualifications, product approval documents, medical device certification and packaging markings, marking, and the establishment of the purchase, inspection and acceptance records. Sales of medical devices should be established sales records.
Medical device purchase, acceptance, sales records, must indicate the name of the medical device, product registration number, specifications, production lot number or product number, expiration date, manufacturer, purchase and sale of units, purchase and sale of quantities, purchase and sale of prices, purchase and sale date. Sterile medical devices must indicate the sterilization lot number. Medical device acceptance records should also indicate the quality of acceptance and processing opinions, and acceptance of personnel signatures to confirm.
Medical device procurement, acceptance, sales records should be kept until more than the expiration date or use of one year, and not less than two years. Implantable medical devices procurement, acceptance, sales records should be kept permanently.
Article 21 of the medical device business and use of units should be in accordance with product standards and instructions for the transportation and storage of medical devices, and the establishment of medical device maintenance records.
Article 22 of the use of medical devices shall have the following conditions:
(a) have a sound management system for the use of medical devices;
(b) meet the performance requirements of medical devices, facilities, equipment and sanitation;
(c) with the use of medical devices and appropriate technical personnel;
(d) laws and regulations provide other conditions.
(d) the laws, regulations and other conditions.
Article 23 of the use of medical devices using sterile medical devices, should be in contact with the inner packaging of medical devices and the expiration date of the inspection in advance; inner packaging is damaged, poorly labeled, more than the expiration date, shall not be used.
Article 24 of the medical device use units using implantable medical devices, shall establish, permanently save and provide patients with the following records of use:
(a) the patient's name, gender, age, address, mailing address, contact phone number, medical record number, name of the operation, surgery, surgery time, the surgeon;
(b) the name of the product, the registration certificate No., product code, Specification model, production date, production lot 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.
Article 25 of the use of medical devices should be established to establish regular testing of medical devices, and the establishment of testing records.
Included in the national mandatory verification catalog of medical measuring instruments, in accordance with relevant state regulations.
Article 26 of the medical device production and operation of enterprises to donate medical equipment, should provide the recipient of the medical device registration certificate, medical device production or operation of a copy of the enterprise license, the manufacturer or the statutory body issued by the donation of the test certificate and the state regulations and related information. Other donors who do not have the qualification of medical device production and operation shall provide the donee with legal proof of procurement of medical devices. The donee shall establish acceptance records, and the medical device registration certificate copy of the local drug supervision and management department for the record.