Services to Ease FDA Regulatory Compliance

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.

Pragmatic Compliance LLC 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
  • Creation 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 $225. Registration and listing fees for foreign companies are included in our US Agent fees, of $299. 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.

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