CFG-NE Export Certificate
The CFG-NE certificate is issued by FDA for medical devices that are Not Exported from the United States may be issued for medical devices manufactured outside of the United States.
CFG-NE Certificate Services
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AÂ Certificate to Foreign Government for Device Not Exported from the United States (CFG-NE) is an official document issued by the FDA for devices authorized to be marketed in the U.S. that are manufactured outside of the United States but not exported from the US and comply with the FD&C Act. LMG prepares and submits CFG-NE applications to FDA for device manufacturers whose products are intended solely for export markets.
CFG-NE is a self-certification process. By completing the application, a firm confirms:
- The facility is registered, and the device is listed with the FDA.
- The product is authorized to be marketed in the U.S. and is not under recall.
- All manufacturing facilities comply with FDA regulations.
- The product is not currently being exported from the U.S.
Requirements to Obtain a CFG-NE
- Valid medical device establishment registration for facilities located outside the U.S.
- Devices must be properly listed with the FDA.
- 510(k) clearance or Premarket Approval (PMA) must be active, unless exempt.
- Compliance with 21 CFR 801/809 (Labeling) and 21 CFR 820 (Good Manufacturing Practice).
- No subject of import alerts, recalls, seizures, or injunctions.
CFG-NE Application
Complete preparation and submission of your CFG-NE application to FDA for devices manufactured outside of the United States —authorized to be marketed in the United States.
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Export Compliance
CFG-NE certificates enable export of devices not cleared in the U.S. to foreign markets that require official FDA documentation.
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Standard CFG
For devices that are cleared or approved and legally marketed in the U.S., we also assist with the standard CFG certificate application.
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Device Registration
LMG can support your full FDA device establishment registration and listing alongside your CFG-NE application.
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How It Works
Frequently Asked Questions
What is a CFG-NE certificate?
A Certificate to Foreign Government (CFG) is an official document from FDAÂ 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, and are shipped from outside of the United States to another foreign country provided certain conditions are met.
Under what regulation are CFG-NE certificates issued?
Manufacturers of devices not exported from the United States, as described in section 801(e)(4)(F)(1) of the FD&C Act, may not receive export certificates (i.e., CFGs), but may request a Certificate to Foreign Government for Device Not Exported from the United States (CFG-NE). .
What conditions must be met for CFG-NE?
The device must meet the specifications of the foreign purchaser, not be in conflict with the laws of the importing country, be labeled for export only, and not be sold or offered for sale in the U.S.
Is there a government fee for CFG-NE?
Yes. FDA charges a $175 government fee for CFG-NE applications and $85 for additional certificates (same request).
Need a CFG-NE Certificate?
LMG prepares CFG-NE applications for device manufacturers exporting to international markets.
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