In this article, we will elaborate on the differences between the three categories from the risk level, regulatory perspective and production perspective.

From the risk level, a class, it will not cause direct harm to the human body, such as surgical forceps, tongue depressor and so on, how you use will not directly cause harm to the human body;

The second category, the risk is slightly higher, may indirectly cause greater harm to the human body, such as some monitoring beds, diagnostic instruments, will not directly harm people, but the accuracy of its diagnostic results will bring indirect harm to patients; three categories, that is, the highest risk of medical devices, will cause greater harm to patients directly in the morning, especially the blood class, implants are classified as high-risk medical devices, these devices Improper use of these devices can cause greater harm to the human body.

From the regulatory (registration) point of view, a class of the smallest, by the Municipal Bureau for the record (the new regulations to be implemented will be improved for the record of the Provincial Bureau);

Second class, the need to register in the provincial bureau, and in addition to the Drug Administration of your customers can be exempted from clinical products, other products need to do clinical, and have a system audit; the highest class three, the need for testing, clinical, for the "specification" audit, the need for more documentation to prove the safety and effectiveness of the product.

From the production point of view, one of the requirements of the lowest, regardless of personnel or equipment, can meet your requirements on the line, the second category, the highest three categories, three types of devices must meet the requirements of national standards or industry standards, personnel site equipment are required, and a complete system, from documents, equipment, environment, personnel and so on to control.

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