To apply for a Class I medical device registration certificate in the United States, follow these steps:

1. Determine Device Classification: Confirm that your device is classified as Class I. Most Class I devices are low-risk and do not require premarket approval (PMA) or premarket notification (510(k)).

2. Establishment Registration: Register your manufacturing or importing facility with the FDA. This process must be completed annually through the FDA Establishment Registration system.

3. Device Listing: After registering the establishment, list the specific Class I medical device(s) you intend to market with the FDA. This step is necessary to ensure the FDA is aware of the devices being sold in the U.S.

4. Compliance with Quality System Regulations (QSR): Ensure your manufacturing processes comply with the Quality System Regulations (QSR), which are designed to ensure the safety and effectiveness of your devices.

5. Labeling Requirements: Ensure that the labeling of your Class I device complies with the FDA's requirements. This includes providing proper device descriptions, intended use, and any necessary warnings or instructions.

6. Pay User Fees: Pay the required user fees for establishment registration and device listing, even though Class I devices are generally exempt from 510(k) premarket notification.

7. Postmarket Surveillance: Once the device is on the market, comply with postmarket requirements, such as adverse event reporting, recalls, and maintaining quality controls.

By completing these steps, your Class I medical device will be registered with the FDA, allowing it to be legally marketed in the United States.

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