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FDA Medical Device Establishment Registration Now Open

It's time to renew your medical device establishment registration with the FDA.

doctor's stethoscope and mask

The FDA requires all domestic and foreign manufacturers and importers of medical devices to register every year.

Facilities that fail to obtain a valid medical device establishment registration by December 31, 2020, risk refusal of imports by the FDA or CBP.

For domestic medical device establishment registration,click here.
For foreign medical device establishment registration, click here.

If you have any specific questions regarding this matter, please reach out to your local DSV representative.