Services to Ease FDA Regulatory Compliance

Monthly Archives: November 2017

US Agent for Medical Device Companies November 20, 2017

US Agent for Medical Device companies. All the foreign medical device companies  who are required to comply with FDA registration requirements should appoint U.S Agent for communication with FDA.  US Agent acts acts as medium of communication between FDA and foreign company. Pragmatic offer services to act US Agent for Medical Device companies. Responsibilities of … Continue reading US Agent for Medical Device Companies

FDA NO CHANGES CERTIFICATION OF PRODUCT LISTING November 10, 2017

Under 21 CFR 207.57(b), registrants must submit updated listing information at each June and December if there is change since the previous listing and they must submit this information to the FDA via electronic format, These changes include any drug recently introduced in the U.S. commercial distribution which was not previously listed, any drug which … Continue reading FDA NO CHANGES CERTIFICATION OF PRODUCT LISTING

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