One, with the scale and scope of operation of the quality management organization or full-time quality management personnel. Quality management personnel should have state-recognized relevant professional qualifications or titles; two, with the scale and scope of operation of the relatively independent business premises; three, with the scale and scope of operation of the storage conditions, including storage facilities and equipment in line with the requirements of the characteristics of the medical device products; four, should establish and improve product quality management system, including purchasing, incoming goods acceptance, Warehousing and storage, out of the warehouse review, quality tracking system and reporting system of adverse events; v. Should have the appropriate technical training and after-sales service capacity of its medical device products, or agreed by the third party to provide technical support.
Legal Objective:"Regulations for the Supervision and Administration of Medical Devices" Article V medical device supervision and management follow the principles of risk management, control throughout the process, scientific supervision, social **** governance. Article 6 of the state of medical devices in accordance with the degree of risk to implement classification management. The first category is a low degree of risk, the implementation of routine management can ensure its safety, effective medical devices. The second category is a moderate risk, need to strictly control the management to ensure its safety, effective medical devices. The third category is a high risk, need to take special measures to strictly control the management to ensure the safety and effectiveness of medical devices. Evaluation of the degree of risk of medical devices should take into account the intended purpose of the medical device, structural features, use and other factors.