FDA Medical device registration

FDA Medical Device Registration Qucik and Easy 

FDA Registration and Device Listing Services

FDAbasics offer medical device registration and listing services at the lowest fee. We also offer US Agent service for foreign companies. Our annual fee for US Agent services is $ 299 per year, and registration/listing assistance fee is $ 199.  We can list as many devices and free assistance to update the registration/listing information. 

 

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.

FDAbasics 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.

  • PUS Agent services for foreign companies
  • PDevice classification
  • PIdentification of initial importer requirements
  • PObtaining operator number and registration number
  • PDevice and proprietary name listing
  • PAssistance for FDA’s registration fee payment

Why Choose FDAbasics for Medical Device Establishment Registration and Listing?

  • PCompetitive fees
  • PFast processing
  • PTransparent services, with no hidden charges or increased annual fees
  • PAdvice and guidance on the applicable regulatory requirements for your device
  • PAssistance for device classification
  • PFREE registration and listing services for our US Agent clients
  • PNo separate fees for device listing
  • PCreation of cover sheet and PIN to help you process your FDA fees payment

For US-based companies looking for assistance for device registration and listing, our fees are $299. Registration and listing fees for foreign companies is $ 498, this fee includes annual US agent fee $ 299 and multiple device listings. Our prices reflect excellent value for a high-quality service. Please note, medical device facilities are also required to pay FDA registration fees (for 2023, $7,653). 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 hours and help you to release your shipment.

To proceed with the registration, please complete the 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.