Over the past few weeks I’ve had several conversations with manufacturers and consultants alike regarding the export of an Unapproved Investigational Device for use in a Clinical investigation to be conducted entirely outside the United States. One of the first comments I get asked: does the FDA have jurisdiction? While the answer is easy, Read More …
Tag: FDA Approval
Skip Domestic. Commercialize in a Foreign Market first?
Over he last few months, several companies that had not commercialized their products in their domestic markets asked me about entering one or another foreign market. Normally, I tell them that’s probably not a good idea. The reasons behind my statement are straightforward. Entering a foreign market is more difficult than addressing your Read More …
Hurdles facing European MedTech companies wanting to enter the US Medical Device market.
Last week I visited the Medica show in Dusseldorf, Germany, the world’s biggest medical devices trade fair. 120,000 professional visitors from over 130 different countries met with more than 5,000 companies. I spend four days meeting with European MedTech companies that didn’t have a presence in the US market. I wanted to know why they Read More …
Invest in a Strategic International Business Development Plan. Consider Regulatory Restrictions
As your company contemplates expanding its market into foreign countries, sometimes regulatory restrictions play an important role. Think about a company selling supplements, or mechanical components for the aerospace industry. In such an environment, investing in a Strategic International Business Development Plan may mean the difference between certain failure and success. Regulatory Restrictions It may very well Read More …