Explore the most recent editions of MPO Magazine, featuring expert commentary, industry trends, and breakthrough technologies.
Access the full digital version of MPO Magazine anytime, anywhere, with interactive content and enhanced features.
Join our community of medical device professionals. Subscribe to MPO Magazine for the latest news and updates delivered straight to your mailbox.
Explore the transformative impact of additive manufacturing on medical devices, including design flexibility and materials.
Learn about outsourcing options in the medical device sector, focusing on quality, compliance, and operational excellence.
Stay updated on the latest electronic components and technologies driving innovation in medical devices.
Discover precision machining and laser processing solutions that enhance the quality and performance of medical devices.
Explore the latest materials and their applications in medical devices, focusing on performance, biocompatibility, and regulatory compliance.
Learn about advanced molding techniques for producing high-quality, complex medical device components.
Stay informed on best practices for packaging and sterilization methods that ensure product safety and compliance.
Explore the latest trends in research and development, as well as design innovations that drive the medical device industry forward.
Discover the role of software and IT solutions in enhancing the design, functionality, and security of medical devices.
Learn about the essential testing methods and standards that ensure the safety and effectiveness of medical devices.
Stay updated on innovations in tubing and extrusion processes for medical applications, focusing on precision and reliability.
Stay ahead with real-time updates on critical news affecting the medical device industry.
Access unique content and insights not available in the print edition of the MPO Magazine.
Explore feature articles that delve into specific topics within the medical device industry, providing in-depth analysis and insights.
Gain perspective from industry experts through regular columns addressing key challenges and innovations in medical devices.
Read the editor’s thoughts on the current state of the medical device industry.
Discover the leading companies in the medical device sector, showcasing their innovations and contributions to the industry.
Explore detailed profiles of medical device contract manufacturing and service provider companies, highlighting their capabilities and offerings.
Learn about the capabilities of medical device contract manufacturing and service provider companies, showcasing their expertise and resources.
Watch informative videos featuring industry leaders discussing trends, technologies, and insights in medical devices.
Short, engaging videos providing quick insights and updates on key topics within the medical device industry.
Tune in to discussions with industry experts sharing their insights on trends, challenges, and innovations in the medical device sector.
Participate in informative webinars led by industry experts, covering various topics relevant to the medical device sector.
Stay informed on the latest press releases and announcements from leading companies in the medical device manufacturing industry.
Access comprehensive eBooks covering a range of topics on medical device manufacturing, design, and innovation.
Highlighting the innovators and entrepreneurs who are shaping the future of medical technology.
Explore sponsored articles and insights from leading companies in the medical device manufacturing sector.
Read in-depth whitepapers that explore key issues, trends, and research findings for the medical device industry.
Discover major industry events, trade shows, and conferences focused on medical devices and technology.
Get real-time updates and insights live from the CompaMed/Medica conference floor.
Join discussions and networking opportunities at the MPO Medtech Forum, focusing on the latest trends and challenges in the industry.
Attend the MPO Summit for insights and strategies from industry leaders shaping the future of medical devices.
Participate in the ODT Forum, focusing on orthopedic device trends and innovations.
Discover advertising opportunities with MPO to reach a targeted audience of medical device professionals.
Review our editorial guidelines for submissions and contributions to MPO.
Read about our commitment to protecting your privacy and personal information.
Familiarize yourself with the terms and conditions governing the use of MPOmag.com.
What are you searching for?
January 18, 2006
By: Rene Van De Zanderilind Elezaj
Have Distributors Set Up in Europe? Now What?
In the November/December issue we discussed how to find, analyze and select distributors in Europe. Now we will discuss how to handle everything that happens after you arrange work with those distributors. Let’s get started.
Preparing Contracts
Perhaps you have selected a distributor in France, and the time has come to ink a contract. Now you have many considerations to evaluate.
Handling Payments
For purposes of simplicity, we will discuss three common payment methods: Payment in Advance, Letter of Credit and Terms. Each represents increasing levels of risk to the exporter. Payment in advance is exactly as it sounds—the distributor pays you up front before the shipment leaves your loading dock. Typically, this is done through wire transfer and only at the beginning of the relationship, until trust has developed. The second option involves a Letter of Credit (LOC), which is often used for larger orders but protects both you and the buyer at the same time. LOCs are letters issued by banks to authorize the seller to collect money from the buyer’s bank account only if certain conditions set forth in the letter are met (eg, proof that the products were shipped). The final form of payment is called Open Credit or Terms—typically Net 30. Providing terms to a supplier usually happens after the first shipment. However, do not underestimate the risk of doing so. There are many stories of buyers who place a few smaller orders, prepay to establish trust, then place a large order, ask for terms and then don’t pay or pay very slowly. Collecting your money from a company in Europe has a lower success rate than collecting from a company in Virginia. Be vigilant. The Export-Import Bank of the USA (EXIM Bank) has an excellent export credit insurance program for US medical equipment manufacturers. To learn more, visit www.exim.gov. If you export from the United States, also be aware of currency fluctuation and the impact this can have on your market share. If you are in a price-sensitive category, this could have a substantial impact on your sales in the market. One option is to open a European bank account.
Documentation
If you are shipping products from the United States, you cannot simply slap a shipping label on the crate and send it on its way. Make sure all your documentation is in order before you ship. When in doubt, ask your distributor or freight forwarder for guidance. Customs officials can hold your shipment if the necessary paperwork is not attached and may even go so far as to destroy your merchandise (we have seen this happen recently in Italy).
Shipping and Duties
There are many types of shipping: CIF, FOB, DDP, Ex Works, etc. I won’t explain them here, but I do recommend you visit www.iccwbo.org to determine which method is best suited to your situation. You should also know that every product imported to a country is assigned an HTS code by Customs. Many medical devices fall under Chapter 90 of the HTS and have duties that range from 1% to 8%. Many others have no duty. Customs officials in the country where your product first enters the European Union will determine the classification of your product. This is relevant because the first classification made by a Customs official in the European Union is used from then on to determine your product’s rate of duty. You can see the entire HTS code in PDF format by visiting www.usitc.gov/tata.
VAT
Europe has a tax called the Value Added Tax (VAT). It’s much like the US state sales tax but is levied regardless of whether the goods will eventually be resold in the European Union. The distributor will need to pay the VAT (rates range from 15% to 25%)—but will also collect a refund on the amount paid because the goods are intended for resale. Governments can be slow to process refunds, so there is a short-term burden for distributors—and plenty of paperwork.
Returns and Servicing
Do not forget to consider the critical issue of product returns and servicing. Will your distributor handle returns? How will damaged products be handled? If your product is serviceable, will it be returned to the United States for service? If so, what is the cost of doing so? Shipping between the United States and Europe can cost up to four to eight times more than domestic shipping. That’s important to understand, because there comes a point where shipping costs and administration outweigh the value of the product. If you manufacture a serviceable product, the cost and time associated with product returns and repairs are important considerations in choosing a distributor. For example, if your product costs $900 wholesale, can you afford to have the distributor return it to you for servicing if the cost of speedy return shipment is $150 (and this doesn’t include your time to repair it and ship it back to Europe) plus duties? Perhaps it may be best to outsource that task to the distributor or a European device repair facility. These decisions depend on the value of your product, complexity of servicing, frequency of repairs, customer service needs and liability issues. Consider all the implications before signing a contract.
Performance Management
Who will manage the ongoing distributor relationship after the honeymoon? Many companies handle this in-house, but it can be a challenge to deal with companies in Europe because of differences in time, culture/business practices and language. Companies often underestimate the amount of work involved in nurturing these relationships and end up disappointed by their sales in Europe. You may want to consider outsourcing that role to a company with a presence in Europe.
Resources
Sites such as www.export.gov and www.customs.gov have excellent information on exporting, and you should explore all they have to offer. One final point should be considered: The most important key to success in Europe (or anywhere) is remembering that every successful relationship depends on reciprocity and respect. Success is sustainable only if it’s mutual. Rene van de Zande is president and CEO of Emergo Group, a consulting firm that provides quality assurance, regulatory affairs and distribution services.
Enter your account email.
A verification code was sent to your email, Enter the 6-digit code sent to your mail.
Didn't get the code? Check your spam folder or resend code
Set a new password for signing in and accessing your data.
Your Password has been Updated !