MEDICAL DEVICE ESTABLISHMENT REGISTRATION AND DEVICE LISTING
Companies who are involved in manufacturing, testing, packing, labeling, sterilization or import of medical devices are required to register their facility, pay FDA registration fees, and list their devices with the FDA. Medical device companies must also review their medical device establishment registration and listing information annually, and renew their registration.
ORIGO offers FDA medical device registration and listing services at competitive fees. With over twenty years of experience, we can provide expert advice on all regulatory requirements for medical devices. Our complete solution will give you the support you need until you have met all the FDA medical device regulations.
Our FDA Medical Device Registration services include:
US Agent services for foreign companies
Device classification
Identification of initial importer requirements
Obtaining operator number and registration number
Device and proprietary name listing
Assistance for FDA’s registration fee payment
Why Choose Pragmatic for Medical Device Establishment Registration and Listing?
Competitive fees
Fast processing
Transparent services, with no hidden charges or increased annual fees
Advice and guidance on the applicable regulatory requirements for your device
Assistance for device classification
FREE registration and listing services for our US Agent clients
No separate fees for list devices
Our prices reflect excellent value for a high-quality service. Please note, medical device facilities are also required to pay FDA registration fees (for 2017, $3,382). We can help you set up your account and create your PIN to pay your fees directly to the FDA accounts.
We also offer quick processing and immediate assistance for any company whose shipments are on hold because of regulatory compliance issues. We can obtain an FDA operator number for your facility within 24 hour, and help you to release your shipment.
To proceed with registration, please complete online medical device registration and listing form. If you need help, please contact us. You can find answers to your questions in our medical device FAQ section.