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COVID-19 UPDATES

July 8th Update

The State of Maryland has announced a Phase II plan, and we are working diligently in the office to serve you!

Thanks to the selfless service of Healthcare workers and Marylanders for staying home and practicing social distancing. The State of Maryland is slowly on its road to recovery.

WCS is observing the Maryland State guidelines to ensure a safe work environment for our staff and for our community.

The US Department of State is currently prioritizing all life and death matters with respect to document processing; hence the authentication process for corporate documents has been significantly delayed. The Maryland Secretary of State has developed reliable procedures that give us reasonable turnaround times, yet are not as efficient as pre-COVID-19. More Embassies have opened for public service, but with limited staff and operational hours.  Even with these challenges, WCS is processing your documents most effectively. We are trying our best to keep the pressure on our leading partners to reduce backlogs and delays.

Processing times will return to normal as soon as the Federal, State agencies, and Embassies resume its operations in full strength. Nevertheless, please continue to send your documents for authentication and we suggest not to hold them back for later.

We highly appreciate our customers for their trust, patience, and consideration during the pandemic. Thank you for your incredible support!

We are in this together; please be safe and healthy!

WCS TEAM

May 18th Update

Dear Valued Customers,

Thank you for your tremendous patience and understanding during these unprecedented times. WCS is ever grateful to all our customers for trusting us to steer your legalization ship.

The  Maryland State has relaxed its “stay at home orders” for certain counties, hence WCS is working with reduced capacity in office and the remaining staff is assisting customers remotely.

Government agencies like the Department of State and Embassies in DC are still in Stay at home orders with limited hours of operation. Even so we have found out ways to work around this fluid situation with a delayed turnaround.

WCS is taking all safety measures to ensure your documents are safe for processors to handle. FedEx, UPS & USPS packages are delivered to our office, with no contact delivery. All received packages are disinfected, as per the CDC’s guidelines before it can be handled by our team. We are aware that the Government Departments and Embassies are also practicing social distancing and safe document handling.

We are anticipating delays in the legalization process due to safety measures, limited staff hours at the Government and Embassies. Despite all these restrictions in place, WCS will continue to assist you with all your authentication needs, kindly continue to send your documents to WCS as usual.

WCS is committed to serving its clients throughout these challenging times.

Thank you and stay safe.

WCS TEAM

April 2nd Update

To our valued and prospective clients:

WCS office is closed under the order from the Governor of the State of Maryland, requiring only essential businesses to stay open. We have made arrangements with FedEx, UPS, and USPS to continue delivering documents to our office. Please know that your documents will be safe in our office. Meanwhile, WCS staff will be working remotely to accept and process electronic documents as applicable within the time frames and restrictions in the current market. We will respond to email and voicemail queries promptly.

We are taking this step as we are good corporate citizens and want to ensure the health of our employees and the community. We are continuing to monitor the situation and will update everyone as soon as we have any relevant information.

Thank you for your cooperation and patience in this crisis. We look forward to working with you as soon as possible.

WCS Team

March 17 Update – WCS has learned that the Embassies of Egypt and Saudi Arabia will remain closed until March 24, 2020 and the Embassy of Qatar until April 1, 2020. Please expect delays in document processing through these Embassies. We’re working diligently to accommodate your requests.

Please expect delays in document processing through these Embassies. We’re working diligently to accommodate your requests at this time.

COVID-19 Resources

Read prevention measures from the Centers for Disease Control and Prevention here and review the following household checklist from the CDC to see their recommendations on how to plan and make decisions now that will protect you and your family during a COVID-19 outbreak.

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COVID 19’s Impact on the Global Health Industry

In the wake of COVID-19, the global health industry has been put to the test. Age-old protocols were threatened as social distancing and illness threatened to wreak havoc on companies. While nearly all industries have had to work to adapt to the rapidly-spreading illness, the global health field has had their work cut out for them. Currently, many of those companies are experiencing or anticipating work stoppages due to COVID-19.

1. RA & Quality Control: Document Authentication Backlog

Document authentication is an often overlooked component of regulatory affairs in the global trade life cycle. In mid-March, embassies began to close, or run on minimal staffing. Now, this created an immense problem for regulated goods headed to Non-Hague countries, as embassy legalization is necessary to export and sell in those destinations. While finalized products face this issue, products on an earlier bend of the quality control cycle risk developmental delays. With social distancing in place and many employees now remote, review cycles and timelines for products have been impacted.

2. FDA Overriding Supply Chain Security Requirements

With the intent of combatting COVID-19 and related illnesses, the FDA issued guidance detailing exclusions and exemptions to certain requirements under the Drug Supply Chain Security Act, due to the urgency of COVID-19 by the end of April.

To keep things moving forward, the FDA has been doing all it can to ensure Med/BioTech companies are able to respond to the rapidly evolving battle against COVID. The FDA published a nine page guidelines document on COVID, and explained their exemptions under the DSCSA. Download the full guidelines from FDA here.

“Under the DSCSA, specific activities are automatically excluded from certain DSCSA requirements upon the declaration of a public health emergency.”

FDA

3. EU MDR Postponed to May 2021

The most massive impact on the industry has been the postponement of the EU’s Medical Device Regulations, introduced in 2017 and originally set to launch in May of 2020. With Notified Bodies already overwhelmed, the delays brought on by COVID forced a delay into 2021.Read our EU MDR updates here.

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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.

Arthrex: Manufacturing Face Shields for Healthcare Workers Amidst COVID-19 Crisis

The panic at the spread of the dangerous virus caused a spike in hand sanitizer, toilet paper, and unfortunately, extremely crucial face masks. With this horrifying scarcity looming over our healthcare providers, companies and communities alike are stepping up and coming together to do what they can to protect our frontline workers.

Arthrex, a massive Southwest Floridan company, mainly specializes in manufacturing orthopedic devices for surgeons, with the mantra “Helping Surgeons Treat Their Patients Better.” However, the outcry from our hospital heroes left Arthrex hoping to help. On April 14th, an FL news station reported “Arthrex has made 300 face shields and 25 protective hoods” and they’re en route to producing “up to 500 face shields a day.”

This whole process has been truly inspiring to see both the community at Arthrex and the community at large rallying together against the battle against COVID 19….It’s not just the first responders and the nurse. We’re all in this as one”

Dr. Christopher Adams

Click here to read the full article about Arthrex’ involvement in protecting our hospital workers in this pandemic.

Washington Consular Services is immensely proud of Arthrex’ 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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