Tag Archives: FDA

New Requirements for FDA Medical Device Establishment Registration and Listing

As I mentioned in a previous blog, FDA is updating their requirements for Medical Device Establishment Registration and Listings. The changes begin in four days, starting October 1, 2012. The two biggest changes that I initially noted were as follows: … Continue reading

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Important Update – Changes to Medical Device Establishment Registration Requirements!

This is an important update for all importers who have registered Medical Device Establishments with the FDA. Owners or operators of businesses that are involved in the production and distribution of medical devices intended for use in the United States … Continue reading

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