Apostille Services for Medical Device Companies: Ensuring Global Compliance and Seamless Export Operations

Executive Summary: Medical device companies expanding into global markets face stringent documentation and compliance requirements. Apostille services streamline international certification, ensuring documents are recognized in over 120 countries. This blog explores the apostille process, its importance for medical device firms, and how to stay compliant while saving time and resources.



In an increasingly interconnected world, medical device companies are innovating at a rapid pace and distributing their products worldwide. However, global expansion requires more than product readiness—it demands comprehensive documentation that meets the legal and regulatory standards of each target country. Apostille services offer a standardized method to authenticate documents for international use, ensuring smooth cross-border operations.

Medical device firms often need to certify documents like Certificates of Free Sale (CFS), Certificates to Foreign Governments (CFG), ISO certifications, FDA approvals, and notarized affidavits. Without proper authentication, delays and rejections can halt international shipments and complicate regulatory approval.

This blog details how apostille services work, why they matter, and what steps companies can take to maintain global compliance.



What Is an Apostille and Why It Matters for Medical Device Companies?

An apostille is a certificate issued under the Hague Apostille Convention of 1961, which authenticates the origin of a public document for use in another member country. It eliminates the need for diplomatic or consular legalization, simplifying international transactions.

For medical device companies, apostilles validate:

Regulatory compliance

Corporate legitimacy

Product safety certifications

Export readiness


Without apostilles, companies risk border delays, denied certifications, or blocked imports/exports.



Common Documents Medical Device Companies Must Apostille

1. Certificate of Free Sale (CFS)

Proves a device is legally sold in the U.S. Required by countries like Brazil, China, and Saudi Arabia for import approval.

2. Certificate to Foreign Government (CFG)

Issued by the FDA, this document assures foreign authorities that your device complies with U.S. regulations.

3. ISO 13485 Certification

Indicates your company meets international quality management standards. Required for many international partnerships.

4. FDA Device Clearance Letters (510(k), PMA, etc.)

Used in regulatory filings abroad to demonstrate a device's legal marketing status in the U.S.

5. Notarized Business Documents

Includes power of attorney, board resolutions, corporate bylaws, and manufacturing declarations.

6. Import/Export Licenses and Technical Files

Countries often require these for customs clearance and local regulatory review.




The Apostille Process Explained

Step 1: Document Preparation

Ensure your documents are final, signed, and where needed, notarized.

FDA-issued documents like CFGs must be obtained directly from the agency.


Step 2: Notarization (if required)

Documents like power of attorney or declarations must be notarized by a licensed notary public.


Step 3: County Clerk Authentication (Some States)

In some U.S. states, notarized documents must be authenticated at the county level before the apostille.


Step 4: State Apostille

Submit your document to the Secretary of State where notarization occurred. The apostille confirms the notary or issuing officer's authority.


Step 5: Federal Apostille (If Applicable)

For documents issued by federal agencies (e.g., FDA CFGs), the U.S. Department of State provides the apostille.


Step 6: Embassy Legalization (For Non-Hague Countries)

Countries not party to the Hague Convention require consular legalization, a more complex, multi-step process.





Apostille vs. Legalization: What’s the Difference?

Apostille: Used for countries in the Hague Apostille Convention.

Legalization: Required for countries outside the convention (e.g., UAE, China). Involves State Department and consulate review.


Knowing which process applies saves time and avoids costly delays.




Top Export Countries & Their Apostille Requirements

1. European Union (Germany, France, Spain)

Apostille accepted from state authorities

Often requires translations certified by sworn translators


2. Japan

Accepts apostilles on FDA and ISO documents

High demand for Certificates of Free Sale


3. Mexico & Brazil

Apostille required on CFS and CFG documents

Brazil requires notarized translations of apostilled documents


4. India

Accepts apostilles from the U.S. for ISO, FDA, and notarized legal documents


5. United Arab Emirates & Qatar

Not Hague members; require full consular legalization




Real-World Example: Apostille Delays Blocking a Product Launch

A Boston-based medical device company was preparing to launch a new orthopedic implant line in Spain. The company overlooked the need to apostille their ISO 13485 certification and FDA clearance letter. Spanish regulators rejected their initial submission, causing a 3-month delay. Once the documents were apostilled correctly, approval went through within 2 weeks.

Lesson: Proper document authentication upfront avoids regulatory setbacks.



How Apostille Services Simplify the Process for Medical Device Firms

1. Expert Navigation of Bureaucracy

Professionals handle federal and state-level submissions

Avoid missteps and rejections


2. Faster Turnaround Times

Rush apostille and expedited embassy legalization available

Ideal for time-sensitive exports


3. Document Tracking and Updates

Get real-time updates and secure document delivery


4. Bulk Document Handling

Apostille services can manage dozens of files simultaneously, from ISO certs to corporate bylaws





Best Practices for Medical Device Companies

1. Create an Apostille Document Checklist

Include all commonly required certifications, licenses, and notarized forms.

2. Work With an Experienced Apostille Provider

Partner with professionals who understand FDA, ISO, and international compliance standards.

3. Keep Digital Copies of Everything

Upload all certified and apostilled documents to a secure company repository.

4. Plan for Translations

Some countries require apostilled documents to be translated by certified translators.

5. Stay Updated on Global Regulatory Changes

Laws change—an experienced provider stays on top of destination country requirements.




Why Choose Our Apostille Services for Medical Device Firms

At Boston Notary Service and Colon Constable Services, we specialize in helping life sciences and medical device companies authenticate their documents accurately and efficiently.

We offer:

Decades of experience with FDA, ISO, and international compliance

In-person and remote apostille support

Nationwide document pick-up and drop-off

Same-day and rush apostille options

Consular legalization for non-Hague countries


Let us streamline your international documentation so you can focus on innovation, not bureaucracy.




Ready to Get Started?

Let’s take the guesswork out of global compliance. Whether you’re expanding into Europe, Asia, or the Middle East, we’ll ensure your medical device documentation is apostilled or legalized correctly, quickly, and affordably.

Contact us today:

Boston Notary Service: [email protected]


Call us: 617-230-6676

Order directly online: https://bostonnotaryservice.us/apply-here


We handle the paperwork, so you don’t have to.




Boston Notary Service are not law firms and do not provide legal advice. We recommend consulting an attorney for legal questions related to document content or jurisdictional rules.