Business management system covering the whole process of quality management, and make relevant records, to ensure that business conditions and business behavior continue to meet the requirements can be.
Based on the "supervision and management of medical devices business approach" Article 30: medical device business enterprises should be in accordance with the requirements of the quality management standard for medical device business, the establishment of quality management covering the whole process of business management system, and make good records, to ensure that the operating conditions and business behavior continue to meet the requirements.
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, should provide the official seal stamped with the authorization of the enterprise. The authorization shall contain the authorized sales of varieties, geographic area, period, indicating the salesperson's identity card number.
Expanded:
Medical device filing requirements stipulate:
1, medical device operators should take effective measures to ensure that the medical device transportation, storage process in line with the medical device instructions or labeling requirements, and make the appropriate records, to ensure the quality and safety of medical devices.
2, instructions and labeling requirements of low temperature, refrigeration, should be in accordance with relevant regulations, the use of low temperature, refrigeration facilities and equipment for transportation and storage.
3, medical device operators entrusted 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 during transportation, to ensure quality and safety in the transportation process.
Guangdong Provincial People's Government-Medical Devices Business Supervision and Management Measures