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WCS OCTOBER UPDATE

The State of Maryland has moved to Stage Three of the Maryland Strong: Roadmap to Recovery. Stage Three updates safety protocols and expands reopening plans. However, Washington DC and other neighboring states are still in Phase 2 of their respective COVID-19 recovery plans.

We continue to experience delays in authentication from the US Department of State. We are hopeful of an improvement in the coming months, as we have enlisted the assistance of our congressional delegations and industry associations to encourage more efficiency in document processing to reduce turnaround times for documents. State authorities and Embassies in Washington, DC have adapted to the crisis and turnaround times are predictable and improving.

We are also pleased to inform you that the Embassies of Vietnam and Egypt are now accepting documents directly (without processing through the U.S. Department of State) and this has greatly improved processing for these countries.

Our staff is practicing social distancing while working to meet our client needs. Additionally, we are taking all preventative measures to sanitize and safeguard the workspace as guided by our state.

WCS has recently launched a new website to bring in an exclusive user experience. WCS Express™ application provides the best option for legalization of your documents. The Submit a Request form is now replaced by the Order Now button, which will take you directly to WCS Express™. If you’ve never created an account–don’t worry, it’s simple and free to register! Please, contact us if you need more information. The WCS team is at your service, should you require any additional assistance,

Thank you for your continued support, stay safe and we hope you will enjoy using WCS Express™!

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.

Abbott Launches a Five Minute Test to Detect COVID-19

On March 27th, Abbott announced that the FDA had approved and declared their COVID-19 detection test the fastest on the market. At the crippling rate this is spreading, a quick test is more critical now than ever.

The Abbott ID NOW™ COVID-19 test brings rapid testing to the front lines

  • Test to run on Abbott’s point-of-care ID NOW platform
  • a portable instrument that can be deployed where testing is needed most- ID NOW has the largest molecular point-of-care installed base in the U.S. and is available in a wide range of healthcare settings
  • Abbott will be making ID NOW COVID-19 tests available next week and expects to ramp up manufacturing to deliver 50,000 tests per day
  • This is the company’s second test to receive Emergency Use Authorization by the FDA for COVID-19 detection; combined, Abbott expects to produce about 5 million tests per month

-Abbott

Read the full press release from Abbott here.

Washington Consular Services is immensely proud of Abbott’s dedication in getting in front of the spread of the COVID-19 virus, and by being their Apostille and Legalization partner.

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