Article 47 An enterprise shall bear legal responsibility for the purchase and sale of medical devices by its offices or sales personnel in the name of the enterprise. When selling medical devices, the sales staff of an enterprise shall provide a power of attorney stamped with the official seal of the enterprise. The power of attorney shall specify the variety, area and time limit of authorized sales, and indicate the ID number of the salesperson.

Enterprises engaged in the wholesale business of medical devices shall sell medical devices to legitimate buyers. Before the sale, the buyer's certification documents and business scope shall be verified, and the buyer's file shall be established to ensure that the sales flow of medical devices is true and legal.

Article 48 Enterprises engaged in the wholesale and retail business of Class II and Class III medical devices shall establish sales records, which shall at least include:

(1) Name, specification (model), registration certificate number or filing certificate number, quantity, unit price and amount of the medical device;

(2) The production batch number or serial number, expiration date and sales date of the medical device;

(three) the production enterprise and the license number of the production enterprise (or the registration certificate number).

For enterprises engaged in the wholesale business of medical devices, the sales records shall also include the buyer's name, business license number (or registration certificate number), business address and contact information.

Article 49 Enterprises engaged in the retail business of medical devices shall issue sales vouchers to consumers, and record the name, specification (model), name, quantity, unit price, amount, retail unit, business address, contact telephone number and sales date of medical devices, so as to facilitate quality traceability.

Article 50 When medical devices are out of the library, the keeper shall check and accept the medical devices out of the library. If any of the following conditions is found, it is not allowed to leave the warehouse, and it shall be reported to the quality management organization or quality management personnel for handling:

(a) the packaging of medical devices is damaged, polluted, the seal is not firm, and the seal is damaged;

(two) the label falls off, the handwriting is blurred or the marked content is inconsistent with the real thing;

(3) The medical device has expired;

(4) Medical devices with other abnormal conditions.

Article 51 Medical devices shall be re-examined after leaving the warehouse, and records shall be established. The re-inspection contents include name, specification (model), registration certificate number or filing certificate number, production batch number or serial number, production date and validity period (or expiration date), manufacturer, quantity, factory date, etc.

Article 52 The substitute packing box for LCL delivery of medical devices shall be marked with striking delivery contents.

Article 53 Medical devices that need to be refrigerated or transported by freezing shall be packed and loaded by special personnel and meet the following requirements:

(a) the car refrigerator or incubator shall meet the corresponding temperature requirements before use;

(2) Packaging and sealing should be completed in a refrigerated environment;

(three) before loading, should check the start-up and running state of refrigerated trucks, after reaching the specified temperature, before loading.

Article 54 When an enterprise entrusts other institutions to transport medical devices, it shall evaluate the quality assurance capability of the carrier in transporting medical devices, clarify the quality responsibility in the transportation process, and ensure the quality and safety in the transportation process.

Fifty-fifth refrigerated trucks, vehicle freezers and incubators that need to be refrigerated and frozen for the transportation of medical devices shall meet the temperature control requirements during the transportation of medical devices. The refrigerated truck has the functions of temperature display, automatic temperature control, alarm, storage and reading of temperature monitoring data.

Chapter VIII After-sales Service

Article 56 An enterprise shall have the professional guidance, technical training and after-sales service capabilities suitable for the medical devices it operates, or agree relevant institutions to provide technical support.

The enterprise shall, in accordance with the procurement contract, agree with the supplier on quality responsibility and after-sales service responsibility to ensure the safety of after-sales use of medical devices.

Where an enterprise and a supplier agree that the supplier is responsible for product installation, maintenance and technical training services or relevant institutions agree to provide technical support, there may be no department or personnel engaged in professional guidance, technical training and after-sales service, but there should be corresponding management personnel.

Enterprises that provide customers with installation, maintenance and technical training by themselves should be equipped with professionally qualified personnel or trained by manufacturers.

Article 57 Enterprises shall strengthen the management of returning goods, ensure the quality and safety of medical devices in the process of returning goods, and prevent adulteration of fake and shoddy medical devices.

Article 58 An enterprise shall, in accordance with the requirements of the quality management system, formulate operating rules for after-sales service management, including complaint channels and methods, file records, investigation and evaluation, treatment measures, feedback and follow-up afterwards.

Article 59 An enterprise shall be equipped with full-time or part-time personnel to be responsible for after-sales management. For the quality and safety problems complained by customers, it shall find out the reasons, take effective measures to deal with them and give timely feedback, make records, and notify suppliers and medical device manufacturers when necessary.

Article 60 An enterprise shall timely record the after-sales service processing results and other information in the archives for inquiry and tracking.

Article 61 An enterprise engaged in the retail business of medical devices shall publish the supervision telephone number of the food and drug supervision and administration department in the business place, set up a customer suggestion book, and promptly handle customers' complaints about the quality and safety of medical devices.

Article 62 An enterprise shall, in accordance with the relevant provisions of the State, provide full-time or part-time personnel to undertake the monitoring and reporting of adverse events of medical devices, and cooperate with the monitoring institutions of adverse events of medical devices and the food and drug supervision and administration departments in the investigation of adverse events.

Article 63 If an enterprise finds that the medical devices it operates have serious quality and safety problems, or do not meet the mandatory standards and the technical requirements for registering or filing medical devices, it shall immediately stop operating, notify relevant production and operation enterprises, users and purchasers, and record the situation of stopping operating and notifying. At the same time, immediately report to the food and drug supervision and administration department where the enterprise is located.

Article 64 Enterprises shall assist medical device manufacturers to fulfill their recall obligations, timely convey and feed back medical device recall information according to the requirements of the recall plan, control and recall medical devices with potential quality and safety hazards, and establish medical device recall records.

Chapter IX Supplementary Provisions

Article 65 The operation of medical devices through the Internet shall comply with the relevant supervision and management measures formulated by China Food and Drug Administration.

Article 66 These Standards shall come into force as of the date of promulgation.