Apostille for Medical Device Industry



Medical device companies that import or export their products across nations frequently deal with a slew of legal paperwork that the authorities require. Such legal documents issued in the United States must be verified before they can be deemed genuine by authorities in other countries. However, the procedure of authenticating these types of documents can be confusing, resulting in a situation that wastes time and money. The method of document authentication, especially the Apostille, is briefly explained in this article.


The aim of authentication, as defined by international treaties and agreements, is to confirm the authenticity of a legal document and the signature of a public worker. For the most part, most countries allow two forms of verification:


Legalization: This is the most typical procedure. It entails a chain authentication of the legal document involving various officials from the issuing country. The Embassy or Consulate of the nation where the document will be used completes the last stage. This is a time-consuming and costly procedure. In nations that have signed the Vienna Convention on Consular Relations, legalizations are accepted.


Apostille: This is a streamlined process that involves the issuing of an Apostille authenticity certificate. An authorized authority from the country from where the document was issued conducts this authentication. The nations that signed the agreement accept this authentication procedure as stated in the Hague Convention of 5 October 1961 Abolishing the Requirement of Legalization for Foreign Public Documents.


The Apostille is a quick, low-cost, and practical technique of authentication. However, in order to be Apostilled, the papers must meet certain requirements:

  • The country of origin and destination of the document must be member of the Hague Convention, if this is not the case, Legalization is the only option.

  • The document must be considered as a public document.

  • The Apostille is only for documents to be used abroad.

The following are some documents that are relevant to the medical device industry and can be apostilled:

  • Free Sale Certificates,

  • Good Manufacturing Practices Certificates

  • Extracts from commercial registrations

  • Patents

  • Notarial acts

  • Acknowledgement of signatures,

  • Letters of Representation

  • Contracts and Agreements between companies and manufacturers

Additionally, an Apostille can only be given by a Competent Authority in the document's country of origin. If there is enough space, apostilles are affixed to legal documents on the same page. Otherwise, a second page with the Apostille might be added. Finally, all member nations can use a common template to issue an Apostille document. Some countries, on the other hand, can add extra information or even issue digital Apostilles.


It's worth noting that apostilles only certify the signature or seal of the person or official authority whose signature or seal appears on the document. The Apostille does not vouch for the document's authenticity.


The Apostilles may be refused in the nation where the legal papers are to be used if the following conditions are met:

  • The Apostille does not certify the signature correctly,

  • The origin of the document cannot be verified,

  • The Apostille was placed over the original text of the document.

Please email me at jared@apostillellc.com if you want to learn more about getting a document properly verified and ready to be approved.

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