What are the three types of medical devices?

Judging from the level of risk, the first category, such as surgical forceps and tongue depressor, will not cause direct harm to human body, and no matter how you use it; The second category, with slightly higher risk, may indirectly cause great harm to human body, such as some monitoring beds and diagnostic instruments, which will not directly harm people, but the accuracy of their diagnosis results will indirectly harm patients; The third category is the medical devices with the highest risk, which will directly cause great harm to patients when they get up in the morning, especially blood-borne and implantable medical devices which are classified as high-risk medical devices. Improper use of these devices will cause great harm to human body.

From the perspective of supervision (filing), the first category is the least effective and will be filed by the municipal bureau (the new regulations to be implemented will be raised to the provincial bureau for filing); Secondly, it needs to be registered in the provincial bureau. Except for the clinical products that can be exempted from inspection by the guests of the Food and Drug Administration, all other products need clinical review and systematic audit; The third category is the highest, which requires testing, clinical examination and "code" audit, and more documents are needed to prove the safety and effectiveness of the product.

From the production point of view, the first category has the lowest requirements, and both personnel and equipment can meet your requirements, followed by the second category and the third category. The third type of equipment must meet the requirements of national standards or industry standards, have requirements for personnel and equipment, and have a complete system to control documents, equipment, environment and personnel.

I don't know much about management, but according to different levels, the qualification requirements are different.

Unknown, please consult; Deficiencies, please add; If there is anything wrong, please point it out; thank you