MEDICAL DEVICES
Apostilles for Medical Device Companies
Registering a device in Saudi Arabia, Brazil, the UAE or elsewhere? We authenticate FDA export certificates through the U.S. Department of State, and notarize and apostille your declarations, letters of authorization and powers of attorney.
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MEDICAL DEVICES
Federal and state documents
Each authenticated through the right channel.
- FDA export certificates
- Declarations of conformity
- Authorized representative letters
- Embassy legalization
Documents for registering medical devices abroad
How each document is authenticated
| Document | How it is prepared | Authenticated by |
|---|---|---|
| FDA Certificate to Foreign Government (CFG) | Issued electronically by FDA with a QR code; print in color | U.S. Department of State (never notarize) |
| FDA Certificate of Exportability | Issued electronically by FDA | U.S. Department of State |
| Declaration of conformity or manufacturer declaration | Signed by a company officer before a notary | Secretary of the Commonwealth, or the state where signed |
| Letter of authorization or authorized representative appointment | Signed before a notary | Secretary of the Commonwealth |
| Power of attorney for a local registration holder | Signed before a notary | Secretary of the Commonwealth |
| ISO 13485 certificate copy | Certified as a true copy as the destination requires | Secretary of the Commonwealth, after notarization |
| Certificate of good standing | Issued by the state of formation | That state |
Requirements vary by regulator and change over time. Your local agent or regulator's current checklist governs.
Ready to get started?
Tell us what you need, and we will take care of every step.
Apostille or legalization for common markets
| Market | Route for U.S. documents |
|---|---|
| Saudi Arabia | Apostille (since December 7, 2022) |
| Brazil, Mexico, China, Indonesia | Apostille |
| United Arab Emirates | Authentication and legalization (consolidated digital process) |
| Egypt, Kuwait, Qatar, Jordan | Authentication and embassy legalization |
Based on the Hague Conference status table. See our Embassy Legalization page for the full chain.
Electronic FDA certificates
How we work with regulatory teams
- 1
Review the registration checklist
Send us the list from your local agent or regulator. We map each document to the right authentication path.
- 2
On-site signing
We come to your office along Route 128, in Kendall Square or the Seaport to notarize declarations, letters and powers of attorney, several signers in one visit.
- 3
State and federal authentication
State filings in person in Boston, and federal submissions through our DC Satellite Office.
- 4
Legalization, translation and delivery
Embassy legalization where required, certified translation, and delivery to your local agent with tracking.
Good to know
Never notarize FDA certificates
Notarizing a federal document invalidates it for apostille or authentication.
Print in color
FDA requires electronic export certificates to be printed in color for authentication.
Certificates of free sale
Pharma and biotech
See Life Sciences and Clinical Research and CROs.
Common mistakes we help you avoid
- Notarizing an FDA certificate. It cannot then be authenticated by the U.S. Department of State.
- Black-and-white prints of electronic certificates. FDA requires color printing for authentication.
- Apostilles for legalization countries. The UAE, Egypt, Kuwait, Qatar and Jordan require the legalization chain.
- Inconsistent company details. Names, addresses and signatory titles should match across every document.
- Expired certificates. Check validity dates before submission.
Official sources
- FDA: exporting medical devices
- FDA: transition to electronic export documents
- FDA: removal of notary block from export certificates
- U.S. Department of State: apostille requirements
- Hague Conference: Apostille Convention status table
Requirements change, and the receiving office always has the final word. We confirm current requirements with every quote.
Frequently asked questions
Who apostilles an FDA Certificate to Foreign Government?
The U.S. Department of State, because it is a federal document. Massachusetts cannot apostille it.
Should an FDA certificate be notarized?
No. Notarizing a federal document invalidates it for authentication.
Can you notarize declarations of conformity at our office?
Yes. We come to your office and notarize every signer in one visit.
Do you handle legalization for the UAE and Egypt?
Yes, including state and federal authentication and embassy legalization.
Registering a device abroad?
Send us your registration checklist, and we will authenticate every document through the right channel.