Hivebench fda compliance registration#
The Official Correspondent is responsible for the registration and listing information for each establishment to which he/she is assigned. The Official Correspondent also receives correspondence from the FDA involving the owner/operator and any of the firm’s establishments. The person designated by the owner/ operator of an establishment responsible for the annual registration of the establishment and the device listing. Per FDA definition, an Official Correspondent is defined as: Agent support setup, including confirm of the QNR team's consent to act as a representative/liaison on behalf of the foreign establishment.Įstimated miscellaneous support throughout the year.Ĭustomized packages and flexible payment options are also offered. The standard package rate includes the following services: Please note that these service as U.S Agent are limited in comparison to the other packages, and is primarily an in-country point of contact for your establishment. Agent, and such an action shall be considered to be equivalent to providing the same information or documents to the foreign establishment. If FDA is unable to contact the foreign establishment directly or expeditiously, FDA may provide information or documents to the U.S. Responding to questions concerning the foreign establishment's devices that are imported or offered for import into the United States,Īssisting FDA in scheduling inspections of the foreign establishment and Agent include the following:Īssisting the FDA in communications with the foreign establishment, The QNR team resides domestically within the U.S. or maintain a place of business in the U.S. Agent needs to meet, including that the U.S. There are certain requirements that the U.S. The QNR team can support your business in this capacity to serve as point of contact with the FDA. Per FDA requirements, 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.
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