Article 30 The medical device business enterprise shall, in accordance with the requirements of the standard for managing the quality of medical device business, establish a business management system covering the whole process of quality management, and make relevant records to ensure that the business conditions and business behavior continue to meet the requirements.
Article 31 of the medical device business enterprises to its office or sales staff in the name of the enterprise engaged in the purchase and sale of medical devices bear legal responsibility. Medical device business enterprise sales personnel sales of medical devices, shall provide the stamped official seal of the enterprise's authorization. The authorization shall set out the authorized sales of varieties, geographic area, period, indicating the salesperson's identity card number.
Article 32 The medical device business enterprises shall establish and implement the purchase inspection record system. Engaged in the second and third class medical device wholesale business and the third class medical device retail business enterprises shall establish a sales record system. Incoming inspection records and sales records information should be true, accurate and complete.
Enterprises engaged in the wholesale business of medical devices, its purchase, storage, sales and other records should meet the traceability requirements.
Incoming inspection records and sales records should be kept until 2 years after the expiration date of the medical device; no expiration date, not less than 5 years. Implantable medical devices purchase inspection records and sales records should be kept permanently.
Encourage other medical device business enterprises to establish sales record system.
Article 33 The medical device business enterprises shall purchase medical devices from qualified manufacturers or business enterprises.
Medical device business enterprises shall agree with the supplier of quality responsibility and after-sales service responsibility to ensure the safe use of medical devices after sale.
Agreement with the supplier or the corresponding organizations responsible for product installation, maintenance, technical training services of medical equipment business enterprises, may not be engaged in technical training and after-sales service department, but there should be appropriate management personnel.
Article 34 of the medical device business enterprises shall take effective measures to ensure that the medical device transportation, storage process in line with the medical device instructions or labeling requirements, and make appropriate records to ensure the quality and safety of medical devices.
Instructions and labeling requirements for low-temperature, refrigerated, should be in accordance with relevant regulations, the use of low-temperature, refrigerated facilities and equipment for transportation and storage.
Article 35 of the medical device business enterprises commissioned other units 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, clear quality responsibility, to ensure that the quality and safety of the transportation process.
Article 36 of the medical device business enterprises for other medical equipment production and management enterprises to provide storage, distribution services, shall sign a written agreement with the commissioning party to clarify the rights and obligations of both parties, and with the product storage and distribution conditions and scale of equipment and facilities, with the commissioning party to carry out real-time electronic data exchange and realize the whole process of product management can be traced back to the computer information management platform and the technical means. Technical means.
Article 37 of the wholesale business of medical devices business enterprises should be sold to qualified business enterprises or use units.
Article 38 The medical device business enterprises shall be equipped with full-time or part-time personnel responsible for after-sales management, customer complaints about the quality of the problem should be identified, take effective measures to deal with and feedback in a timely manner, and make a good record of it, and if necessary, shall notify the supplier and the medical device manufacturer.
Article 39 of the medical device business enterprises do not have the original business license conditions or with the filing information does not match and can not get in touch with the original licensing or filing department after the public notice, according to law, the cancellation of its "Medical Device License" or in the second class of medical devices business filing information to be marked, and to the public notice.
Article 40 of the third class of medical devices business enterprises shall establish quality management self-examination system, and in accordance with the requirements of the standard for quality management of medical device business project-wide self-examination, at the end of each year to the municipal food and drug supervision and management department of the location of the annual self-examination report submitted to the municipal level.
Article 41 of the third class of medical devices business enterprises to suspend their own business for more than one year, to re-open, should be reported in advance in writing to the municipal food and drug supervision and management department of the location, after verification of compliance with the requirements before resumption of business.
Article 42 The medical device business enterprises shall not operate without registration or filing, no qualification documents and expired, expired, out of medical devices.
Article 43 The medical device business enterprises operating medical devices in the event of a major quality incident, shall be reported within 24 hours of the location of the provincial, autonomous regions, municipalities directly under the Central Food and Drug Administration, the provincial, autonomous regions, municipalities directly under the Central Food and Drug Administration shall immediately report to the State Food and Drug Administration.
Be sure to record with the latest requirements and related documents.