US FDA Export Certificates

  

When should an Export certificates are requested: To export a medical device to foreign government

 Prerequisites of export certificates,

Export Certificates type	Legally marketed devices in the United States	Establishment Registration	Device Listing	Labelling	QSR	Comply with laws of exporting country
Certificate to Foreign Government (CFG)	Yes	Yes	Yes	Yes. applicable labeling requirements	Yes	Yes
Certificate of Exportability: Section 801(e)(1)	No	Yes	May be	Device labeled as “intended for export” or “for export only	No	Yes
Certificate of Exportability: Section 802	No. Devices meet performance standards per Section 514 of the FD&C Act –for Class II and III devices not legally marketed	Yes	May be	Establishments substantially conform to CGMPs   Device is not adulterated Devices are in accordance with specifications of foreign purchaser	No	Yes. Devices are marketed in the countries listed in Section 802 (b)(1)(A)(i) and (ii) of the FD&C Act

  Other export certificates are,

• Non-Clinical Research Use Only Certificate
• Export Permit Letters (EPL) per Section 801(e)(2) for Class III, investigational
•  Simple Notifications per Section 802(g)

 From whom CFG is obtained: CDRH

The Center for Devices and Radiological Health (CDRH) is responsible for issuing export certificates for medical devices. To obtain an export certificate, a request must be submitted and CDRH will provide approval or denial of the request.

 How to obtain a CFG: CDRH Export Certification and Tracking System (CECATS)

FDA Unified Registration and Listings System (FURLS) have  CDRH Export Certification and Tracking System (CECATS) System. CECATS allows manufacturers to request export documents, including Certificates to Foreign Governments.

The following information are required for CFG,

• Section 1 - Requestor Information
• Section 2 - Manufacturer Information
• Section 3 - Distributor Information
• Section 4 – Product Information
• Section 5A – Was the product ever recalled?
• Section 5B – INJUNCTION
• Section 5C – SEIZUR
• Section 6 – List Country(ies) for which the Certificates are requested
• Section 7 – Indicate what product information should appear on the certificate.
• Section 8 – Should the country destination be listed on the certificate?
• Section 9 – Exporter's Certification Statement (ECS)
•  

All establishment should register with FDA via FDA Online Account(FDAOAA) 

FDA OAA account ID and password may be used to access or create subaccounts for CDRH Export Certification and Tracking System (CECATS)

CECATS may be accessed after logging into the FDA Unified Registration and Listing Systems (FURLS)

Timelines:

Certificates issued within 20 business days if applicable requirements are met

References

Types of Export Certificates: https://www.fda.gov/medical-devices/exporting-medical-devices/types-export-certificates