WCS Processing New FDA Digital Documents, Business As Usual

WCS Processing New FDA Digital Documents, Business As Usual

Questions have arisen about processing the FDA’s digital documentse-CFG’s, e-CPP’s, and others. The convenience and cost-savings are useful to our clients, as the FDA uploads the documents to the pharmaceutical and medical-device companies in digital format, which eliminates significant handling of physical documents.

Once received, clients send the documents to us at WCS, likewise in digital format—and we take it from there. WCS prints the document and prepares it for submission to the U.S. Department of State, essentially the same handling as there was in the old-school days when FDA delivered the documents as physical “hard copies”.

In summary, there is every reason to welcome the new format, with very little change in procedures.Simply receive the documents in digital form, and upload them to WCS Express, our easy-to-use online ordering platform.

China-is-Up-and-Running

China is Up and Running

China has taken a giant step forward to simplify and improve the process of global document authentication.

Sixty years after the creation of the Apostille Treaty in The Hague, Netherlands, hastening the flow of crucial documents across borders, China has ratified the treaty. Then, in January of 2024, Canada will join the treaty system, leaving a shrinking group of nations to with the traditional system.

Not alone among long-term holdouts, which include Indonesia, Canada, Singapore, Saudi Arabia, Pakistan, Vietnam, Egypt, Turkey, and others, the China-process involved costly fees and weeks spent at local Consulates waiting for stamping to be completed. This was all a product of hallowed traditions, in which sovereign nations applied diplomatic and bureaucratic certifications to inbound documents. Compounded with the time required at the government agencies of the issuing countries, delivery of products and services was often delayed, against the backdrop of rapidly modernizing transportation and digital communications.

Along the way from 1961 to present, China’s procedures for dispute resolution and other matters were unable to be reconciled with the Hague Convention, the international body that created the treaty. Major corporations and law firms became involved in specific dispute-resolutions. Prior to the Apostille Treaty, China had ratified another vital Hague Convention Treaty in 2005, the Hague Convention on Protection of Children, governing Inter-Country adoptions.

With China’s ratification of the Treaty on November 7, 2023, the number of signatory countries, from Brazil to India, totals 124. With many of the previous holdouts also joining in the last several years, the old ways of document authentication are disappearing into history. For global manufacturers and marketers, adopting parents, transnational workers, exchange students, and bi-national families, the savings in time and money are considerable—and often critical to the flow of global trade and travel.

Today, all you need is to notarize your document in the jurisdiction-of-origin. Once this is done, simply submit an online order through WCS Express™, and we will handle the rest for you.

Visit Washington Consular Service today and click on the ORDER NOW tab to access online ordering. 

A digital world in the hands of a human

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.

Submit a Request is now WCS Express -Get Started with your order now!