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Medical devices that are not FDA approved or cleared for marketing legally in ..... .fda.gov/downloads/AboutFDA/ReportsManualsForms/Forms/UCM052378.pdf.

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A Certificate to Foreign Government (CFG) is required by many medical device market regulators in Asia, the Middle East, and Latin America in order to legally sell your product in their territories.

A Certificate to Foreign Government is issued for legally marketed devices in the United States that are in compliance with the requirements of the Federal Food, Drug, and Cosmetic Act (FD&C). Eligibility Note: Are cleared or approved by FDA for marketing in the U.S. May be legally commercially distributed in the U.S.

The CFG is available for products that meet the applicable requirements of the FD&C Act for marketing in the United States. The COE is available for products that may not be sold in the United States but meet the requirements of section 801(e)(1) of the FD&C Act and may be legally exported.

A Certificate to Foreign Government for Device Not Exported from the United States (CFG-NE) may be issued for medical devices manufactured outside of the United States that are cleared, approved, licensed, or are not required to submit a premarket report pursuant to subsection (l) or (m) of section 510 of the FD&C Act, ...

The only requirement that is currently being enforced, however, is the presentation of a CFG or FSC. If the product is manufactured in the United States, the CFG is required. If the product is manufactured outside the United States, the FSC from the appropriate country is required.

Industry may request most types of FDA-issued export certificates for food products through the CFSAN Export Certification Application and Tracking System (CFSAN eCATS). CFSAN eCATS is one of the FDA Industry Systems available at https://.access.fda.gov.

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© Copyright 1997-2025
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Form Packages
Adoption
Bankruptcy
Contractors
Divorce
Home Sales
Employment
Identity Theft
Incorporation
Landlord Tenant
Living Trust
Name Change
Personal Planning
Small Business
Wills & Estates
Packages A-Z
Form Categories
Affidavits
Bankruptcy
Bill of Sale
Corporate - LLC
Divorce
Employment
Identity Theft
Internet Technology
Landlord Tenant
Living Wills
Name Change
Power of Attorney
Real Estate
Small Estates
Wills
All Forms
Forms A-Z
Form Library
Customer Service
Terms of Service
Content Takedown Policy
Bug Bounty Program
About Us
Blog
Affiliates
Contact Us
Privacy Notice
Delete My Account
Site Map
Industries
Forms in Spanish
Localized Forms
State-specific Forms
Forms Kit
Legal Guides
Real Estate Handbook
All Guides
Prepared for You
Notarize
Incorporation services
Our Customers
For Consumers
For Small Business
For Attorneys
Our Sites
US Legal Forms
USLegal
FormsPass
pdfFiller
signNow
airSlate workflows
DocHub
Instapage
Social Media
Call us now toll free:
+1 833 426 79 33
As seen in:
  • USA Today logo picture
  • CBC News logo picture
  • LA Times logo picture
  • The Washington Post logo picture
  • AP logo picture
  • Forbes logo picture
© Copyright 1997-2025
airSlate Legal Forms, Inc.
3720 Flowood Dr, Flowood, Mississippi 39232