MEDICAL DEVICE FDA REGISTRATION AND 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. The annual medical device facility registration fee for the fiscal year 2022 is $5672

  • Domestic Manufactures or Initial Importers

  • Foreign Manufactures

  • Foreign Manufactures

 TRUSTED REGULATORY EXPERTS & US AGENTS

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.

Contact Us

BEST PRICE OFFER

We guide, We review, We apply, We reply

  • 24 X 6 Chat support

  • 6 days working and processing files

  • Economic pricing and polite staff

449 USD. Additional Devices 50 USD each

Establishment Registration and Renewal: 100 USD

Device Listing: 300 USD(One day service)

REGISTRATION AND LISTING

How long the process will take to complete?

The registration and listing may take around 3-5 days.

FOREIGN ESTABLISHMENT REGISTARTION

Is US Agent Mandatory?

All foreign manufacturers and Exports must appoint US Agent.

JOIN THE TEAM. APPLY NOW

MAIL APPLICATIONS

12345 North Main Street,
New York, NY 555555
Phone: 1.800.555.6789
Email: support@your-domain.com
Web: Themefusion.com

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