The state of medical devices in accordance with the degree of risk to implement three categories of management.
The first category is a low risk, the implementation of routine management can ensure the safety and effectiveness of medical devices, such as ordinary surgical knives, scissors, tweezers and so on. The second category is a moderate risk, need to take measures to strengthen control to ensure the safety and effectiveness of medical devices, such as pacemakers, artificial crystals, vascular stents and so on.
The third category is a higher risk, need to take special measures to strictly control to ensure the safety and effectiveness of medical devices, such as implantable cardiac pacemakers, artificial joints, heart valves, intravascular catheters and so on. In addition, the state also implements registration management for some medical devices, that is, they need to be registered and approved by the State Food and Drug Administration before they can be marketed.
Registration-managed medical devices usually carry a high level of risk and need to provide sufficient evidence of safety and efficacy before they can be approved. In short, the state's classification and management of medical devices is based on the degree of risk, aiming to ensure the safety and efficacy of medical devices and protect public health and safety.
Medical device company registration requirements:
1, qualification license
Medical device companies must have the relevant qualification licenses, including medical device business license and medical device manufacturer license. These qualification license documents are necessary to apply for registration, proving that the company has the relevant ability to engage in the operation and production of medical devices.
2, a certain amount of money
Registered medical device companies need a certain amount of money, including registered capital, start-up costs, office space rental costs. These funds are the basis and guarantee for starting a medical device company, and are used for the normal operation and business development of the enterprise.
3, professional personnel
Registered medical device companies need to have professional and technical personnel, including quality management personnel, technicians, sales staff and so on. These personnel must undergo relevant training and assessment, with appropriate professional knowledge and skills, to ensure that the business standardized operation, product quality is stable and reliable.