Registrar Corp to present Seminar on U.S. FDA Medical Device Regulations at FIME Show in Miami
Hampton, Virginia (PRWEB) July 31, 2013 -- On August 8, 2013 at 11am, Registrar Corp will present a FDA Medical Device Compliance Seminar at the FIME Show in Miami Beach, Florida. Registrar Corp's FDA Medical Device seminar will review changes in U.S. FDA Medical Device Registration and Listing Requirements, including the Medical Device User Fee Amendments (MDUFA) contained in the FDA Safety and Innovation Act (FDASIA).
Effective October 1, 2012, FDASIA imposed several new medical device establishment registrations and listing requirements on medical devices manufacturers.
Some of the new FDASIA medical device requirements include (but are not limited to):
1. All proprietary names under which a medical device is marketed must be reported, at a minimum, when a medical device is first listed and during the annual update of registration and listing information.
2. All contract manufacturers and sterilizers of finished medical devices must register and list regardless of whether they put the medical device into commercial distribution or return the medical device to the manufacturer or specification developer.
3. Initial importers must identify the manufacturers of the medical devices they are importing.
4. Foreign establishments that are exporting medical devices or offering medical devices for export to the U.S. must identify all known U.S. importers of their devices.
5. All establishments that are required to register must now pay an annual registration user fee.
Registrar Corp provided industry with a list of Top 10 Changes to FDASIA imposes on Medical Device Registrations and Listings. Read more at: FDASIA Top 10.
Registrar Corp's seminar will be on August 8, 2013 at 11:00 am in room D237 of the Miami Beach Convention Center. Register to attend the Registrar Corp's complimentary FDA seminar here. The FDA Medical Device Seminar is free to all FIME show exhibitors and attendees.
As a FDA regulatory compliance firm, Registrar Corp assists companies with Medical Device Facility Registrations, Listings, Medical Device Master Files, and other Medical Device Requirements. Registrar Corp has over 20,000 clients worldwide and operates 19 regional offices outside the U.S.
Registrar Corp will continue to keep industry updated on changes to U.S. FDA requirements in order to help Medical Device manufacturers understand and comply with U.S. FDA regulations. For more information on how the MDUFA may affect you, Registrar Corp is available by phone at +1-757-224-0177 or 24/7 via online Live Help. To receive regulatory updates, visit: FDA Regulatory Updates by Registrar Corp.
David Lennarz, Registrar Corp, http://www.registrarcorp.com, +1-757-224-0177, [email protected]
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