Medical Devices Group

  • Community
  • Webinars
  • Jobs
  • Events
  • Contact
  • Go Premium
« Back to Previous Page
Bridget Desroches, M.S., RAC
Regulatory Affairs Specialist at Nova Biomedical
January 2016
International Legalization of Documents Question
< 1 min reading time

I have received a request regarding legalization of documents that I could use some guidance on. The request originates from Mexico, asking that an ISO cert for an OEM be legalized either 1) in the originating country of the certificate issuer or 2) in the originating country of the device manufacturer.
In the past, regardless of the above 2 conditions, we have had the ISO certs legalized here in the US specifically for Mexico. I am at a loss as how to proceed with initiating legalization internationally for a request of this type.
Can anyone point me towards a good resource or provide feedback on their own experience with this?
Many thanks!

source: https://www.linkedin.com/groups/2070960/2070960-6098100696656211969

Marked as spam
Posted by Bridget Desroches, M.S., RAC
Asked on January 27, 2016 8:00 am
34 views
  • Follow
  • Unfollow
  • Report spam

Meet your next client here. Join our medical devices group community.

Private answer
Karen Boyd, ASQ CQA Typically, the document is notarized, then distributed to appropriate secretary of state for seal, then forwarded to that consulate, embassy, or country delegate office for authentication or apostille (contingent upon Hague or non-Hague).

If you're still uncertain, I would go back to the originator of the request and gain a clearer understanding of the needs.
Marked as spam
  • Report spam
Private answer
Pernelle Kruse Schøndorff Karen is right. If the device is produced in Germany get the document notarized in Germany and afterwards get the Apostille (Also Germany). Finally take the document to the Embassy of Mexico to get the final stamp (also Germany) Often you need to pay some kind of fee.
Marked as spam
  • Report spam
Private answer
Ee Bin Liew in general, Karen's advice is sound and the correct approach, so I second that.
Marked as spam
  • Report spam
Private answer
Karen Boyd, ASQ CQA Hi Bridget - Were you able to make any headway on your document legalization?
Marked as spam
  • Report spam
Private answer
Bridget Desroches, M.S., RAC Thanks Karen! That is how we usually obtain legalization. However, apparently the Mexican Agency is now insisting that legalization occur either in the country of residence of the OEM (Poland in this case) or of the ISO cert issuer (TUV Nord/Germany). It has proven to be a frustrating situation to resolve.
Marked as spam
  • Report spam
Private answer
Bridget Desroches, M.S., RAC All, thanks for your feedback. The device manufacturer is actually in Poland, but the certificate issuer is in Germany. Operating out of the US, how would I go about getting a document notarized and apostatized in Germany? Is there an organization in Germany that serves as an intermediary for this service? We have ultimately solved the problem by working through a division of our company located in Germany. Not an ideal solution as is a separate division and the accounting for processing gets complicated. Better if we could interface directly with an intermediary that performs the service that we can arrange PO's with etc..
Marked as spam
  • Report spam
« Back to Previous Page

Please log in to post questions.

  • Go to WP login page

Stay connected with us.

By signing up you are agreeing to our Privacy Policy.

Categories

  • Capital/Investment
    • Business Model
    • Funding
  • Careers
  • Design/Devel
    • Design
    • Development
    • Human Factors
    • Labeling
    • Material Selection
    • R&D
    • Trials and Post-Market
  • Featured
  • Industry
    • Announcements
    • Device Tax
    • Hospital and Health Care
    • Innovation
    • Medtech
  • LinkedIn, etc.
  • Markets
    • Africa
    • Americas
    • Asia
    • Australia
    • Europe
  • Regulating
    • CE Marking
    • EU
    • FDA
    • FDA/EU etc.
    • Notified Bodies
    • Quality
    • Regulatory
  • Selling
    • Distribution
    • Intellectual Property
    • Marketing/Sales
    • Reimbursement
  • Worth bookmarking!
Feature your job here.
logo

Companion to LinkedIn's 350,000 member community

  • Contact
  • Medical Device Marketing
  • In Memoriam
  • Medical Device Conference

The Medical Devices Group   |   Copyright © Terms, Conditions & Privacy

Medical Devices Group
Powered by  GDPR Cookie Compliance
Privacy Overview

This website uses cookies so that we can provide you with the best user experience possible. Cookie information is stored in your browser and performs functions such as recognising you when you return to our website and helping our team to understand which sections of the website you find most interesting and useful.

Strictly Necessary Cookies

Strictly Necessary Cookie should be enabled at all times so that we can save your preferences for cookie settings.

If you disable this cookie, we will not be able to save your preferences. This means that every time you visit this website you will need to enable or disable cookies again.