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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™!

WCS Website: A New Look!

WCS has launched a new website recently to bring in an exclusive user experience. WCS Express™ application provides the best option for legalization of your documents. It provides very clear instructions and makes the process of order management seamless and transparent. We have created this application to give you the convenience of placing orders, checking status, making payments and tracking document submissions and more.

Watch a short video we made recently to introduce WCS Express.

The Submit a Request form is now replaced by the Order Now button, which will take you directly to WCS Express.

It is completely free to use, and very easy to create an account & navigate our services. Click here to log-on to WCS Express™ today!

If you are an existing customer; you should already have the login information to WCS Express. Place your orders in WCS Express and send the original document via mail or request us to process the attachment in WCS Express. Please, reach out to the WCS team at info@wcss.com should you require any additional assistance or have any suggestions.

Thank you for your continued support, we hope you will enjoy using WCS Express!

-WCS TEAM 

 

How the COVID-19 Crisis Exposed Weakness in the International Regulatory Supply Chain

The COVID-19 crisis has been a substantial tragedy. It has devastated the health of communities, economies, and our collective sense of normalcy. For medical device companies, the crisis has triggered an assessment of the resiliency of critical medical supply chains and has led to an examination of all aspects of that supply chain. This article addresses one of the most underappreciated and overlooked links in the regulatory support chain that has been dramatically impacted by the crisis.  Specifically, this article addresses the impact that the crisis has had on international document authentication services (apostille and legalization of regulatory support documents) and how the disruption of these services impacted global medical device sales. Finally, the potential for innovative reform of these processes is addressed.

To legally sell medical device products overseas, companies must comply with the regulatory and legal protocols in the destination country. Part of this compliance is to ensure that certain U.S. documents relating to the products intended to be sold have been authenticated in the U.S. prior to selling those products in the country. The authentication process for the document is either “apostille” or “legalization” depending on whether the destination country is a signatory to the Hague Convention on Abolishing the Requirement of Legalisation of Foreign Public Documents(https://www.hcch.net/en/instruments/conventions/specialised-sections/apostille)(“Hague Convention for International Documents”). Signatory countries accept the apostille for authentication of any other signatory member’s documents. Non-signatory countries require the full legalization process, a lengthier authentication process usually requiring hand stamped certification from a state secretary of state, the U.S. Department of State Office of Authentications, and the Embassy of the destination country.

Since the inception of the Hague Convention for International Documents in 1969, the authentication procedures have relied on the authentication of physical documents. Specifically, documents such as Certificates to Foreign Government (CFG), powers of attorney, letters of authorization, and numerous corporate documents have been authenticated via a physical stamp. The stamped document becomes the official document by the legal authority in the destination country.

These procedures were well understood and worked quite well for most companies over the past 50 years. However, the procedures relied on two components that are now understood to be at risk in a global crisis: (i) the assumed operational capability of government agencies and Embassies and (ii) the transport and utilization of physical documents. The COVID-19 crisis undermined both assumptions, resulting in the inability of overseas affiliates to obtain the necessary authorization to sell medical device products in international markets.

Once the crisis was recognized and emergency powers were implemented by federal and state authorities, the State Secretaries of State offices, the U.S. Department of State, and foreign Embassies restricted or eliminated in-person drop off of documents, cut office staff, limited hours of operation, and required mail-in document submissions. The restriction of in-person drop-off and pick up of documents had a dramatic effect on turnaround times for authentication. For example, prior to the Stay At Home orders, the timeframe for document processing at the US Department of State was 4 business days. Since the start of the pandemic, and as of the beginning of June, the timeframe for document process is 5-6 weeks, an unprecedented slowing of the regulatory approval process for international documents. The WCS office saw a reduction in processing requests of 54% in March 2020, 93% in April 2020, and 58% in May 2020. It is noteworthy that the drop in document requests were not a function of the ebb and flow of the market.Instead, document requests were halted due to a lack of processing capability by regulatory authorities.  

Document requests are a reliable indicator of sales and distribution demand. The drop in processing requests translates to thousands of lost hours of effort to sell and distribute medical products overseas, impacting revenues of affected companies and the health of vulnerable populations worldwide. Even as medical device manufacturers were ready to get back to business, authentication procedures could not be adjusted quickly in response to the crisis. A reliable, simple process was not functioning as it had for decades and there were no contingency plans for new document authentication procedures among state, local and national authorities to address the challenge.

While there was some pressure to automate/digitize these processes before the COVID-19 crisis, there is a new sense of urgency to adopt digital authentication technologies to replace the traditional physical document procedures. For example, the National Association of State Secretaries of State (https://www.nass.org) will be considering electronic authentication of documents at its upcoming conference. Other states, including New York, implemented e-marriage certificates, and adopted other digital authentication procedures during the crisis. Nationally, medical device companies and federal agencies are discussing how to innovate to build more resiliency into document regulatory authentication.

The technological challenge is not overwhelming. After all, most agencies and companies have begun using e-signatures and document authentication tools in the past few years. The challenge will be to get state/federal agencies, foreign Embassies, and international health authority representatives to agree on the acceptance of electronically authenticated documents.  Ultimately, this is regulatory, legislative, technological, and a cultural challenge, but one that is now firmly on the radar of the medical device community.

The writer is David L. Watt, Vice President at Washington Consular Services, Inc. dwatt@wcss.com 

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.

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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