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