Medical devices should be reviewed and establish a record of the review of the contents of what content includes

Chapter VII sales, warehousing and transportation

Article 47 of the enterprise's offices or sales staff in the name of the enterprise to engage in the purchase and sale of medical equipment bear legal responsibility. Enterprise sales staff sales of medical equipment, should provide the official seal of the enterprise seal of authorization. The authorization shall set out the authorized sales of varieties, geographic areas, the period, indicating the salesperson's identity card number.

Enterprises engaged in the wholesale business of medical devices, medical devices should be sold wholesale to legitimate purchasers, before the sale should be on the purchaser's documents, business scope of verification, the establishment of the purchaser's file, to ensure that the flow of sales of medical equipment is real, legitimate.

Article 48 engaged in the second and third class medical device wholesale and third class medical device retail business enterprises shall establish sales records, sales records should include at least:

(a) the name of the medical device, specifications (model), registration certificate number or record certificate number, quantity, unit price, amount;

(b) the production of medical devices or serial number, expiration date, Sales date;

For enterprises engaged in the wholesale business of medical devices, sales records should also include the name of the purchaser, business license number (or record certificate number), business address, contact information.

Article 49 The medical device retail business enterprises, should be issued to the consumer sales vouchers, records of medical equipment, name, specifications (models), the name of the manufacturer, quantity, unit price, amount, retail unit, business address, telephone, date of sale, etc., in order to facilitate the quality of traceability.

Article 50 of the medical devices out of the warehouse, the warehouse custodian should be checked against the out of storage of medical equipment, found the following conditions shall not be out of storage, and report to the quality management organization or quality management personnel to deal with:

(a) the medical device packaging is broken, contaminated, sealing is not secure, sealing damage and so on;

(b) labeling, blurred handwriting, or labeling of the contents of the physical Does not match;

(D) the existence of other abnormalities in the medical device.

Article 51 The medical devices should be reviewed and establish a record, the review includes the purchaser, the name of the medical device, specifications (model), registration certificate number or record certificate number, production batch number or serial number, date of production and expiration date (or expiration date), the production company, the number, the date of discharge and other content.

Article 52 The medical devices shipping boxes should be conspicuous shipping content labeling.

Article 53 The need for refrigeration, freezing transportation of medical devices box, loading operations, should be responsible for by a person, and meet the following requirements:

(a) vehicle refrigerator or thermal insulation box should be used to achieve the corresponding temperature requirements;

(b) should be in a refrigerated environment to complete the packing, sealing work;

(c) loading should be checked before the start of the refrigerated vehicle, the operating status, after reaching the required temperature (C) before loading should check the refrigerated vehicle start, run state, to achieve the required temperature before loading.

Article 54 Enterprises commissioned other organizations to transport medical devices, the carrier should be transported to assess the quality of medical devices to assess the ability to ensure the quality of the transportation process, the quality of clear responsibility to ensure the quality and safety of the transportation process.

Article 55 The transportation of medical devices need to be refrigerated, frozen refrigerated trucks, car refrigerator, thermal insulation box should be in line with the requirements of temperature control during the transportation of medical devices. Refrigerated vehicles with display temperature, automatic temperature control, alarm, storage and reading temperature monitoring data.

Chapter VIII After-sales service

Article 56 The enterprise shall have with the operation of medical devices appropriate professional guidance, technical training and after-sales service capabilities, or agreed to provide technical support by the relevant organizations.

Enterprises should be in accordance with the procurement contract with the supplier to agree on the quality of responsibility and after-sales service responsibility to ensure the safe use of medical devices after sale.

Enterprises and suppliers agreed that the supplier is responsible for product installation, maintenance, technical training services or technical support by the relevant organizations to provide technical support, can not be engaged in professional guidance, technical training and after-sales service departments or personnel, but there should be appropriate management personnel.

Enterprises to provide customers with their own installation, maintenance, technical training, should be equipped with professional qualifications or after the manufacturer's training.

Article 57 Enterprises should strengthen the management of returns to ensure that the return of medical equipment quality and safety, to prevent the mixing of fake and shoddy medical equipment.

Article 58 The enterprise shall, in accordance with the requirements of the quality management system, the development of after-sales service management procedures, including complaint channels and methods, file records, investigation and evaluation, processing measures, feedback and follow-up.

Article 59 The enterprise shall be equipped with full-time or part-time personnel responsible for after-sales management, customer complaints about the quality and safety issues should be identified, take effective measures to deal with timely and feedback, and make a good record, if necessary, should be notified to the supplier and medical device manufacturers.

Article 60 The enterprise should be timely after-sales service to deal with the results and other information into the archives, in order to query and track.

Article 61 engaged in the retail business of medical devices should be published in the business premises of the food and drug supervision and management department of the supervision and management of the telephone number, set up a customer opinion book, and timely handling of customer complaints about the quality and safety of medical devices.

Article 62 The enterprise shall be equipped with full-time or part-time personnel, in accordance with relevant state regulations to undertake the monitoring and reporting of adverse events of medical devices, medical devices should be monitoring organizations, food and drug supervision and management departments to carry out the investigation of adverse events to cooperate.

Article 63 The enterprise found that the operation of medical devices have serious quality and safety issues, or does not meet the mandatory standards, registered or filed by the technical requirements of medical equipment products, should immediately stop operating, notify the relevant production and management enterprises, the use of units, purchasers, and record the cessation of operations and notification. At the same time, immediately report to the local food and drug supervision and management departments.

Article 64 The enterprise shall assist the medical device manufacturer to fulfill the recall obligation, in accordance with the requirements of the recall plan in a timely manner to convey, feedback medical device recall information, control and recovery of medical devices there are quality and safety hazards, and the establishment of medical device recall records.

Chapter IX Supplementary Provisions

Article 65 The Internet business medical devices should comply with the relevant supervision and management methods developed by the State Food and Drug Administration.

Article 66 This specification shall come into force on the date of publication.