What is the domestic registration risk level identification?
The state Food and Drug Administration recognizes the risk levels as follows:
The first category is the low risk degree, the implementation of routine management can ensure its safety, effective medical devices. Therefore, a class of medical devices to implement product record management.
The second category is the medical devices with moderate risk, which need strict control and management to ensure their safety and effectiveness.
The third category is the medical devices with high risk, which need to take special measures to strictly control and manage to ensure their safety and effectiveness. Therefore, the second and third categories of medical devices implement product registration management.
The following materials shall be submitted for filing of category I medical device products and for applying for registration of Category II and Iii medical device products:
1. Product risk analysis data;
2. Product technical requirements;
3. Product inspection report;
4. Clinical evaluation data;
5. Product manual and label sample;
6. management system documents related to product development and production;
7. Other information required to prove the safety and effectiveness of the product.
Medical device registration applicants and record holders shall be responsible for the authenticity of the materials submitted.
