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What is the registration timeline for Class II medical devices in the United States?
Category：企业动态 Date：2024-11-28 17:25:52 Author: Source:
The registration timeline for Class II medical devices in the United States typically ranges from 3 to 6 months, depending on the complexity of the device and the submission process. If a 510(k) premarket notification is required, the FDA's review time can take around 90 days, but it may take longer if additional information or clarification is needed.

The registration timeline for Class II medical devices in the United States typically ranges from 3 to 6 months, depending on the complexity of the device and the submission process. If a 510(k) premarket notification is required, the FDA's review time can take around 90 days, but it may take longer if additional information or clarification is needed.

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