US Agent & Official Correspondent Services
Through Qserve Group US Inc., Qserve is pleased to offer US Agent and Official Correspondent services for medical device manufacturers who wish to sell their products in the United States. It is a requirement of the US FDA regulations that foreign manufacturers retain a US Agent with a physical address within the USA. The US Agent helps ensure that the FDA can contact a foreign manufacturer, when necessary. The US Agent will also assist in scheduling FDA Inspections of the manufacturer’s facilities. In practice, the FDA will usually contact the US Agent first, for the same reasons they would rather that a company identifies a domestic Official Correspondent as described below.
While it is not mandatory to utilize a US entity as Official Correspondent, the FDA prefers to work with US representatives for reasons of language and time zone differences. The Official Correspondent will be contacted by the FDA whenever it has a question about your company or its products. Qserve understands the needs of the FDA and can help prevent misunderstandings that can delay or preclude your product from being sold in the USA. As part of our on-going commitment to better serve our US Agent clients, Qserve will at the client’s request also serve as the client’s Official Correspondent at no extra charge.
Qserve can also undertake:
Preparation and/or Review of Establishment Registration and Device Listing Forms
All device manufacturers must register all of their establishments and devices with the FDA, before the devices can be legally marketed in the U.S. These registrations must be updated annually or whenever a significant change occurs. As an additional service to our clients, Qserve will prepare and/or review these forms and submit them to the FDA. Again, this service is provided at no additional charge, provided the client uses Qserve as their U.S. Agent.
Adverse Event Reporting According to the U.S. Medical Device Reporting (MDR) regulations
All product complaints must be assessed for MDR applicability. The reporting rules are complex with unique forms and requirements. They also change regularly. QSA will assist clients in assessing complaints received from the field and ensure that the proper procedures are followed and, if necessary, that the proper forms are completed and that the FDA is properly notified. There is no additional fee to sign up for this service, and all U.S. Agent clients of QSA receive a reduced rate for each complaint evaluation.
With over 24 years of USA FDA and international regulatory and quality experience , Qserve America working with the Qserve Group, as medical device regulatory consultants, provides coordinated American and European regulatory and quality strategic planning, guidance and implementation from design and development through market launch, including all regulatory documentation and filings. These services are provided to medical device companies worldwide. Additional services include training in FDA regulations and project management, USA Medicare reimbursement assistance, and identification of USA distribution partners.
If you would like more information on how to nominate Qserve to become your US Agent and Official Correspondent, please contact us.