For Class I medical devices; no.
The state of medical devices in accordance with the degree of risk to implement classification management. The first class is low risk, the implementation of routine management can ensure the safety and effectiveness of medical devices. The second category is a medium risk, need to strictly control the management to ensure its safety and effectiveness of 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.
Engaged in medical device business activities, there should be with the scale and scope of business operations and storage conditions, as well as with the operation of the medical device quality management system and quality management organizations or personnel.
Expanded Information:
1, medical equipment business enterprises, the use of units purchasing medical devices, should check the qualifications of the supplier and medical equipment qualification documents, the establishment of purchase inspection record system. Engaged in the second and third class medical device wholesale business and the third class medical device retail business enterprises, should also establish a sales record system.
2, transportation, storage of medical devices, should be consistent with the instructions and labeling requirements of medical devices; temperature, humidity and other environmental conditions have special requirements, should take appropriate measures to ensure the safety and effectiveness of medical devices.
3, medical equipment using units configured with large medical equipment, should be in line with the State Council competent department of health planning large medical equipment configuration planning, and its functional position, clinical service needs, with the corresponding technical conditions, supporting facilities and have the appropriate qualifications, capabilities and professional and technical personnel.
Baidu Encyclopedia - Medical Devices Supervision and Administration Regulations