European authorized representative
For every non European manufacturer it is mandatory to appoint a representative in EU who on his behalf does all the communication with the vigilance body of the country where it is situated and may register his devices with competent authority.
European representative should be chosen with care as is responsible for activities like communication of Regulatory updates to the company and maintain smooth communications with authorities. He also archives the technical file and makes it available to European authorities in case of any emergency.
Any foreign establishment engaged in the manufacture, preparation, propagation, compounding, or processing of a device imported into the United States must identify a United States agent (U.S. agent) for that establishment.
Information about a foreign establishment’s U.S. agent is submitted electronically to FDA and is part of the establishment registration process. Each foreign establishment may designate only one U.S. agent..
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MED DEVICES LIFESCIENCES LIMITED was formed to provide medical device manufacturers world-wide with flexible and well adjusted service packages to assist its clients to comply with EU & US legislation .
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