The state of medical devices in accordance with the degree of risk to implement classification management. Medical devices are divided into three categories:
1, the first category is a low level of risk, the implementation of routine management can ensure its safety and effectiveness of medical devices.
2, the second category is a moderate risk, need to strictly control the management to ensure its safety and effectiveness of medical devices.
3, the third category is a higher risk, need to take special measures to strictly control the management to ensure the safety and effectiveness of medical devices.
The impact and scope of application of medical device industry standards are of great significance to the entire medical device industry. The development and implementation of these standards help to ensure the quality and safety of medical devices and protect the interests of patients. At the same time, these standards also have an impact on the research and development, production and market access of medical devices, promoting the healthy development of the industry. In terms of application scope, these standards cover all aspects of medical device design, production, sales and use, providing uniform norms and guidance for the whole industry and promoting the standardization and sustainable development of the medical device industry. The medical device industry standards issued by the State Food and Drug Administration have been developed through strict procedures and expert review, and have legal effect and must be strictly complied with. Medical device companies must comply with the relevant standard requirements in the process of product development, production and registration declaration, otherwise they will face strict regulatory measures such as failure of product registration and revocation of production license.
In summary, it is critical for medical device companies and practitioners to understand and comply with the medical device industry standards issued by the SFDA.
Legal basis:
"Chinese People's Republic of China and the State Medical Device Supervision and Administration Regulations"
Article VI
Medical device products should comply with the mandatory national standards for medical devices; there is no mandatory national standards, should be in line with the mandatory industry standards for medical devices. And in terms of registration management, it is clearly stipulated that the mandatory standards for medical devices have been revised, the application for renewal of registration of medical devices can not meet the new requirements will not be renewed registration.