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In Country representative

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.

US agent
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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  • I would like to thank entire team of Meddevices for your assistance and guidance in obtaining ISO & CE certification. Your help will be instrumental in our continued growth & success.

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Company Info

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 .

Med Devices 123 fifth Avenue
New York, NY 10160
Ph: +19142942185
Email: info@meddevices.com
                        

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