We are a medical device company, and our main products are Non-absorbable Suture Anchor, etc. Let us share with you the common problems of medical devices.
The state implements classified management according to the degree of risk.
The first category is the low degree of risk, and the implementation of routine management can ensure its safety and effectiveness.
The second category is moderate risk and requires strict control and management to ensure its safety and effectiveness.
The third category is with higher risk, and special measures need to be taken to strictly control and manage to ensure its safety and effectiveness.
To evaluate the degree of risk, factors such as the intended purpose, structural characteristics, and usage methods should be considered.
The Food and Drug Administration of the State Council is responsible for formulating classification rules and classification catalogues, and timely analyzes and evaluates risk changes and adjusts the classification catalogues according to the production, operation and use conditions. When formulating and adjusting the classification catalogue, the opinions of production and operation enterprises, user units and industry organizations shall be fully listened to, and the practice of international classification shall be referred to. The classified catalogue shall be published to the public.
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