our approach aimed at maximizing productivity & efficiency.
US FDA Medical Device Registration and Listing
The manufacturers, initial exporters, initial importers, labeller, reprocessor, specification developer, US manufacturer for the export only medical device and contract sterilizers of facilities intended for use in the United States are required to register with the FDA on an annual basis. Establishment registration is the term for this procedure (Title 21 CFR Part 807).
All establishments that are required to register with the FDA must also specify the devices they manufacture and the operations they do on those devices. majority of the device needs 510k, De Novo, PMA, PDP, HDE number prior to listing.
The FDA requires owners or operators of establishments involved in the manufacturing and distribution of medical devices intended for use in the United States to register with the agency on an annual basis.
FDA Medical Device Listing
FDA Medical Device Listing is a mandatory regulatory requirement under 21 CFR Part 807 for all medical device manufacturers, repackagers, relabelers, and specification developers who market devices in the United States. US Customs and Border Protection checks for device registration and listing before allowing foreign devices to enter the U.S. market. All listed devices appear in the FDA Registration & Listing database, which is searchable by the public, including hospitals and distributors.
FDA Medical Device Registration and Listing FAQ’s
Yes, manufacturers / exporter any time they can transfer the US Agent. We are happy to act as US Agent for any non-US manufacturers. Please bring us the FDA FURLS account login details to update the Agent Information.
Foreign manufactures and exporters interested in selling medical devices in the USA can approach us. Our extensive knowledge of FDA regulations will aid in a smooth and efficient registration process. We the US Agents awake and answer any time when authorities ask for information. In addition to our US office, we have offices in Germany, India, Malaysia, UK and Vietnam.
We are not just like others, we have a big team of device experts, consultants and project managers who can handle any type of service to your organization.
The US Agent Service is vital for FDA medical device registration of foreign medical and in-vitro diagnostic devices manufacturers and initial exporters.
