Schuyler, Roche & Crisham, P.C. Large enough to to the job right, small enough to listen
 

Manufacturing and Distributing Medical Devices Overseas: The How and Why

Whether you are expanding or introducing your business abroad—through manufacturing, distributorships, joint ventures, direct marketing or otherwise—it is imperative to seek legal counsel experienced in surmounting the challenges of foreign regulation, knowledgeable about your industry and adaptable to change. For more than 20 years Schuyler Roche has helped manufacturers and distributors of medical devices to expand in North and South America, Europe, Australia and Asia, concentrating our representation in those countries where developing companies often enjoy success.

Known by Our Diligence
Our collective experience has taught us the complexities of selling medical products overseas, particularly the quandaries posed by approvals, distribution and compensation within business and legal systems different from our own. Our history in navigating through diverse systems positions us to help any manufacturer or distributor of medical products obtain not only the registrations necessary to sell in a particular country, but all requisite approvals.

Creating distributor agreements, service agreements, logistic agreements, leasing agreements and employment agreements is among our strengths. We understand the issues manufacturers and distributors face and the challenges confronting companies that produce, warehouse and deliver product. Our goal as legal counselors is to help clients avoid regulatory and operational pitfalls.

Backed by an International Legal Network
The number of countries in which our clients do business is a telling clue to our responsiveness. Schuyler Roche has spent more than 25 years creating a network of foreign counsel in more than 30 nations. We adapt quickly to the vagaries of unfamiliar markets by building on our base of knowledge and by analyzing the legal and regulatory themes common to the world's major economies. The answers will not be the same from one country to another, but we have developed the expertise necessary to address the problems clients confront.

Making Tax Planning Paramount
When expanding a business internationally, the common thread through all decisions is taxation and how to minimize it. Even the choice of business entity will have a tax effect. Our ability to analyze which type of entity makes sense within a particular environment becomes an important service.

Increasingly Active in China
Recently Schuyler Roche has conducted a number of structuring analyses involving China. Among the most complicated markets to understand, but a market opening rapidly, China is now rewriting its trade regulations to conform to standards of fairness established by the World Trade Organization, of which it is now a member nation.

To a manufacturer or distributor contemplating expansion there, the complexities can seem overwhelming, but the opportunities are real. Whether a company chooses to establish a presence in special economic zones on the mainland (where the laws, albeit changing, exceed world norms for regulation) or in Hong Kong (where application of the laws are more predictable and stable), tax advantages exist. Our familiarity with these issues enables us to point clients toward their level of comfort.

Positioned to Lead
When a law firm understands the products a client makes, the competition it faces and the channels of sale open to it in the international marketplace, its representation can be more effective. Our experience positions Schuyler Roche to guide midsize manufacturers and distributors as they contemplate and enact plans for foreign expansion. Our job is to decipher the legal and regulatory complexities so each client, ultimately, can do its job better.