Why is Class III medical device more stringent? What is the difference between Class I and Class II?

From the risk of high and low point of view, a class of it, will not cause direct harm to the human body, such as surgical forceps, tongue depressor plate and so on, you in how to use it will not directly cause harm to the human body; Class II it, the risk is slightly higher, may indirectly cause greater harm to the human body, for example, some of the guardianship beds, diagnostic equipment, will not directly harm people, but its diagnostic results of the accuracy of the results of the patient will bring about indirect harm; Class III, is the highest risk of medical devices, will be directly to the patient in the morning greater harm, especially blood, implants are classified as high-risk medical devices, the improper use of these devices will cause greater harm to the human body.

From the regulatory (registration) point of view, a class of words, the least effort, by the municipal bureau for the record (the upcoming implementation of the new regulations will be raised to the provincial bureau for the record); Class II is second, need to be registered in the Provincial Bureau, and in addition to the Pharmacovigilance Bureau of your guests can be exempted from the clinical products, other products need to be done clinically, and there is a systematic audit; Class III is the highest, need to be detected, clinically, for the "norms" audit, the need for more information on the documents prove the safety and effectiveness of the product.

From the production point of view, a class of the lowest requirements, whether it is 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, the requirements of the personnel sites and equipment, and there is a complete system of control from the documents, equipment, environment, personnel and so on.

Operational aspects are not well understood, but according to the level of high and low, the qualification requirements are different.

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