6 Tips for Apostille or Document Legalization

When marketing and selling medical devices, pharmaceutical products, cosmetics or foods outside the U.S., your company will be required to have certain regulatory, quality or supporting technical documents authenticated either by apostille or by consular legalization through the embassy of the target country.

The health ministries of countries require assurances that the products entering are safe, effective and in conformance with current Good Manufacturing Practices (CGMPs). Thus, companies are required to submit for review to the ministry copies of the company’s U.S. Food and Drug Administration (FDA) approval certificates such as:

  • Certificate to Foreign Government (CFG),
  • Certificate of Exportability (COE);
  • Certificate of Pharmaceutical Product (CPP)); and its
  • International Organization for Standardization (ISO) certification; or
  • Free Sale Certificate (CFS) to document that its products are free from defect, disease or harmful nature.

Note: CFG is used by FDA to describe a type of certificate referred to in other countries as a CFS.

To confirm authenticity, these certificates need document legalization, authentication or apostille within the U.S. depending on the national ministry’s requirements. To do this, one can handle it in-house or utilize the expertise of a service specializing in efficiently handling this process.

If you choose to handle it on your own, these six quick tips can help you through the document legalization process!

International Business Map

Notified Bodies Update

Even though the EU MDR was postponed until May 2021, the dwindled-down list of Notified Bodies suggests Regulatory Affairs professionals might not want to kick the can too far down the road.

For those looking at the upcoming IVDR, the situation is even bleaker. The IVDR has not yet been postponed, still facing a May 2022 effective date.

“…with only three notified bodies designated against the IVDR so far, potential delays in further designations because of COVID-19 and social distancing could be a real problem for a diagnostics industry that has been preventing from moving towards compliance when there are so many unfinished structures and documents”

@MedtechAmanda

To search the database of designated NBs on NANDO’s website, click here.

Read our updates on EU MDR by clicking here.

Updates on the EUMDR

In response to the COVID-19 pandemic, EU regulators proposed a one-year delay on the new EU MDR, to May 2021.

The EU MDR Date of Application has officially been extended until May 2021. While most Regulatory Affairs and Quality Control professionals are rejoicing in this push-back, keep the ball rolling on meeting new MDR compliance. Those scrambling to review their products’ compliance may be able to exhale, but the race to completion is still on.

In 2017, EU came out with the new MDR, that would go into effect in 2020. Since then, medical device manufacturers have been tasked with determining which of their products need to be re-registered with participating Notified Bodies, in order to meet the new regulations for export in the EU. However, this posed a new problem for RA professionals.

The once lengthy list of Notified Bodies has now dwindled to only a handful. This poses a great problem for many manufacturers as Notified Bodies become more and more overwhelmed with products to register.

Authenticating Academic Documents for Use in Qatar

If you’re planning to teach overseas, or if you’ve ventured out to international job markets, you may have realized that some countries have extra requirements for document authentication. China, Qatar, and Kuwait—just to name a few.

Let’s say you need your education documents (originating in the US) legalized for use in Qatar.

Qatar Diploma / Degree Attestation

The new requirements set by the Qatar Embassy/Consulate require the following documents to be processed together as a set:

1. Original Diploma (Notarized)

2. Original Transcript (Notarized)

3. Original Verification Letter (Notarized) — verification letter must be signed with a live signature and stamped by the registrar’s office and contain the following information

  • Certificate information is accurate
  • Enrollment and attendance (full-time, part-time, distance)
  • Study and tests locations
  • Degree obtained by the student (Diploma, Bachelors, Masters, Doctorate)
  • Duration of the program
  • The actual time the student spent to get a certificate (study start date – study end date)
  • Public or private academic institution
  • *In cases where the student attended more than two institutions, this must be specified in this letter. The letter must mention that the diploma took place on campus, face to face, not online, in case students took some portion online, specify how many classes out of how many on campus-in person.

The three documents specified above will need to be bundled together as one set. The three documents will receive one seal/stamp from the US Department of State, and then will be legalized by the embassy/consulates.

The Qatar consulate will only legalize ORIGINAL documents—photocopies/scanned copies are no longer accepted. You may re-order a diploma with your university for this document legalization process. 

These are the necessary steps that need be completed by the Secretary of State, U.S. Department of State, and the relevant embassy—Qatar’s consulate, in this case.

Before you send these documents in to WCS, each document must be notarized locally by a notary public where the document was issued. Then, the bundle (all the documents together) must be certified by the local secretary of state. Only after these critical steps are completed, should you send in your document bundle to WCS.

Once you’ve sent in the documents to WCS, we’ll send you our Education Records Consent and Release Form — you must return this document to us signed and completed.

From there, WCS will handle the document legalization process. WCS will take the bundle to the US Department of State and finally to the Qatar embassy/consulate.

Better yet, handle this process step-by-step with our app, WCS Express. We’re here to answer any questions you may have throughout this process!

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Teaching Abroad

What Do I Need to Teach Abroad?

Each country has its own requirements, but there are two main documents required for most teaching programs.

You will need:

  1. A copy of your FBI Criminal Background Check
  2. A copy of your MFA College Diploma + Transcript

After obtaining these documents, they must then be certified OR notarized* in the originating state.

Here’s where it gets a little tricky… if the country you are heading to is a signatory of the 1961 Hague Convention, then you need to get an Apostille.

If the country you are heading to is NOT a signatory of the 1961 Hague Convention, then your documents will need to go through Embassy Legalization–which is a more complex, lengthier process of certifying the authenticity of your educational documents.   

What is an Apostille? What’s Embassy Legalization? 

Essentially, both these items are forms of certification from the US government that informs the receiving international government the documents in question are valid and able to be used overseas.

Why do I need to get an Apostille for a criminal background check?

Especially in Asian countries, there has been an unfortunate rise of criminals and sexual predators who have entered the country with the intention of teaching English in their school systems. Because of this, there has been a need for increased security within the education realm, and ESL teaching applicants must now provide certification of their documents.

How do I get an Apostille for my diploma?

  1. Contact your school’s registrar for your school’s policy on notarizing a diploma. Oftentimes, you must request the registrar meet with yourself and a notary to notarize the signature on the diploma.
  1. After you have notarized your diploma, you can mail them into a trusted document authenticating company (WCS…duh!) and let us take care of the rest.

*If your document needs to be notarized, find a notary near you—oftentimes, your banking institution may provide you of this service, or you can find a list of local notaries by state HERE.

*Some countries require that notarized, government-issued document need to be authenticated further through a certification of validity from the Office of the Secretary of State.

REMEMBER: Your diploma MUST be notarized, signed by your Registrar, and Apostilled from the same State the school is located in.

If you’re teaching in Kuwait, Qatar, Saudi Arabia, prepare to be met with strict requirements on degree authentication. You will need to follow additional steps and provide supplemental documentation.

Teaching abroad is going to be an amazing experience. Don’t get bogged down by the complexities of document authentication, contact us and let us handle the grunt work for you.

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