Tag Archives: Establishment

FDA- Multiple Locations and Medical Establishment Registration

Now that FDA has indicated that they will be charging importers for Establishment Registration, some importers have asked me to clarify whether they need to register each and every facility that receives goods. For example, the importer may have a … Continue reading

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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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