Technical Documentation Assessment Certificate
Digital / Online
Fast-track your global medical device registrations with expert federal authentication. A Technical Documentation Assessment Certificate—issued by an EU Notified Body—proves that your medical device’s technical file, clinical data, and risk management comply with strict safety and performance standards. When registering high-risk medical devices (such as Class III or active implantable devices) with ministries of health outside the European Union, a legalized certificate is mandatory to secure market entry.
At US Apostille, we specialize in navigating the complex federal authentication process. We ensure your critical technical assessment certificates are processed flawlessly, securing your Federal Apostille or Embassy Legalization in just 9 business days.
We Accept Both Digital & Physical Assessment Certificates
In the fast-moving medical technology sector, regulatory delays mean lost revenue. We accept both digitally-issued e-certificates and traditional paper credentials to keep your global launches on schedule.
1. Digital (PDF) Submission — Direct & Secure
How it works: If your Notified Body (e.g., TÜV SÜD, BSI, DEKRA) issued your Technical Documentation Assessment Certificate as a secure, digitally-signed PDF, simply upload the original file directly to our portal.
The Benefit: No printing or expensive international courier shipping. We verify the digital credentials and process the document directly for Federal Apostille.
2. Physical (Hard Copy) Submission
How it works: If your certificate has physical "wet-ink" signatures, official stamps, or holographic security seals, you must mail the physical document to our office.
When it is required: This step is mandatory if the destination country (such as China, Egypt, Saudi Arabia, or Brazil) requires a physical original for full Embassy Legalization.
Company Documents
⚠️ Federal Jurisdiction Notice
A Technical Documentation Assessment Certificate is an international regulatory trade document. Therefore, it cannot be apostilled by a local state-level Secretary of State. It requires a Federal Apostille from the U.S. Department of State (Office of Authentications) in Washington, D.C.
Transparent Pricing & Turnaround Times
Document Type
Federal Fee
Service Fee
Total Cost
Processing Time
Technical Documentation Assessment Certificate
(Digital or Physical)
$20
$60
$80
9 Business Days
*Note: Processing times are subject to the U.S. Department of State’s current capacity. For non-Hague countries, additional Embassy fees and processing timelines will apply.
One-day apostille service for your company documents.
We obtain the apostille from the State of Maryland.
Regardless of which state your documents originated from.
Valid for use in all Hague Apostille Convention countries.
Processing time for all Company documents is
1
Business Day.
In real
6 days
US Department closes on Fri, Sat & Sun.
Order today by 4:00 PM
EST. We ship on
April 1, 2026
$50
per document + shipping
No extra fees.
Submit Your Company Documents
Click to select a file
Upload a
scanned copy of your document (PDF, JPEG, PNG)
Select your destination country and document type on the left to see your projected timeline and costs.
Why Medical Device Exporters Trust Us
Regulatory Speed: We are fully integrated with modern e-certification standards to process your digital compliance files without shipping delays.
Direct Washington D.C. Footprint: Located near the U.S. Department of State, we bypass standard mail-in delays to deliver fast, reliable federal authentications.
Global Medical Compliance Experts: We ensure your highly technical conformity and assessment certificates meet the precise, exacting criteria of foreign ministries of health, customs authorities, and international registration bodies.
Frequently Asked Questions
No. A standard scan or photo of a physical paper document is not a digital original. You must provide the original, secure PDF issued electronically by your Notified Body, or mail the physical paper original to our office. The U.S. Department of State will reject standard scans.
For countries that are members of the Hague Apostille Convention, a Federal Apostille is all you need. However, many major medical device markets (such as those in the Middle East, East Asia, or South America) require a multi-step Embassy Legalization process after the Federal Apostille is complete. We handle this entire workflow for you.
Medical device technical certifications are highly time-sensitive and tied to strict regulatory lifecycles. We prioritize these corporate files to ensure the authentication and legalization process is completed well before your current certificate or regulatory window expires.
Yes. We frequently process Technical Documentation Assessment Certificates alongside Declarations of Conformity (DoC), ISO 13485 Certificates, and Certificates of Free Sale (CFS). We can authenticate your entire regulatory submission package as a single, coordinated project.
