1, the risk of different levels
Class II, the risk is slightly higher, may indirectly cause greater harm to the human body, Class III, it is the highest risk of medical devices, will directly cause greater harm to patients.
2, the production of different difficulties
The minimum requirements of class II, whether personnel or equipment, can meet your requirements on the line, the highest class III, class III devices must meet the national standards or industry standards, the requirements of the personnel site equipment, and have a complete system.
3, the intensity of regulation is different
Two categories of less intensity, only need to be registered in the provincial bureau, and in addition to the Drug Administration your guests can be exempted from the clinical products; three of the highest, the need for testing, clinical, for the "norms" audit, the need for more documentation to prove that the product's safety and effectiveness.
Expanded information:
Business class III medical device products, quality management, quality institutions should have a nationally recognized, and business products related to the specialty (medical devices, biomedical engineering, machinery, electronics, etc.) college degree or above, or intermediate or above the technical title of the relevant professional.
Operation of single-use sterile medical devices, there should also be more than one holding a medical device quality management system internal auditor certificate of the internal auditor, shall not be concurrently by the quality manager.
Business class II medical device products, quality management, quality organization shall have a nationally recognized, and business products related to the profession of secondary school education or related professional junior or above technical title.
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