As we have detailed in our previous article, Apostille and Legalization are common procedures to authenticate legal documents in the Medical Device Industry. In this way, local sanitary authorities can validate them.
In the following article, we will explain the general process to authenticate documents through Apostilled since this is the best way if compared with the Legalization process. We will use the case of the United States of America (USA) as an example. However, similar processes are applicable for other countries.
Apostille in the USA
First, it is worth mentioning that the USA has signed the Hague Convention of October the 5th 1961. This convention mainly abolishes the Requirement of Legalization for Foreign Public Documents. Thus, the USA issues and accepts Apostilled documents.
For this case, we can consider three document classifications eligible for Apostille in the USA. Any company or individual located in the USA who wish to get an Apostille for legal documents must have in mind the type of documents and requirements for each case:
- Documents issued by a federal agency or certified by a USA foreign consulate
The first classification includes official documents issued by a federal agency of the USA or certified by a USA foreign consulate. In other words, documents issued by a Department of State such as the Department of Health and Human Services (HSS), including the Food and Drug Administration (FDA). Examples of these kind of documents are:
- Certificates to Foreign Government
- Establishment Inspection Reports
- Approval documents such as 510(k) letters, PMA, among others
- Other public documents
This classification includes a wide variety of documents that can be apostilled. The main requirement for this document is to get a notarization from a state or commissioned public notary.
Examples for these type of documents are:
- powers of attorney
- certificates of good manufacturing practices
- courier letters
- Documents issued by a state of the USA (state-issued)
This classification of documents are the ones issued by a local authority from any of the 50 USA states. Some examples of state-issued documents are:
- Company registrations
Process to Apostille
USA Department of State-Issued Documents and other public documents
Federal issued documents must be authenticated by the USA Department of State trough original seals or true certified copies. All documents must include a legible signature of the official’s name, title, and seal of the agency.
Other public documents can also be Apostilled by the USA Department of State by filling the next requirements:
- To be notarized by a public notary commissioned through the county. These documents must first be certified by the notary in the county, and then certified by the secretary of state where the document was notarized.
- Or to be notarized by a public notary commissioned through the state. The documents must only be certified by the secretary of state in the state where the document was notarized.
In both cases the company or individual must submit a Request Authentications Services by completing the Form DS-4194 and pay a fee of approx. 20 USD. Then hardcopies must be sent by mail or Courier to the physical address of the Office of Authentications in Washington DC.
These kind of documents must be authenticated by the competent authority in the state where the document was executed. In other words, The Secretary of State of each state or an equivalent Agency will locally issue the Apostille for the documents. Therefore, the documents do not require additional certification by the U.S. Department of State.
For example, the California Secretary of State provides an Apostille service to authenticate California public officials’ signatures on documents. These processes can be requested by Mail or via Dropbox.
Apostilled documents from China
As a recent development, on March 8, 2023, China officially acceded to the Hague Convention, which abolishes the Requirement of Legalization for Foreign Public Documents. This convention came into effect between China and Mexico on November 7, 2023. It is important to note that the convention, already in place, for the Special Administrative Regions of Hong Kong and Macau continue to be applicable.
As such, starting from November 7, documents issued in Mexico only require apostille to be used in China, without the need for legalization by the Chinese Embassy. Simultaneously, documents issued in China intended for use in Mexico also do not require legalization from the diplomatic missions of Mexico in China; the apostille alone is sufficient.
The authenticity of the Chinese apostille can be verified online at https://consular.mfa.gov.cn/VERIFY/.
To get an Apostilled document can be a complex process, if you have additional questions regarding how to use apostille legal documents in your regulatory process, please contact us at email@example.com.