For the last 5 years Medical Device companies have worried about the impact of the new Medical Device Regulations on their business, and what would happen May 26th, 2020, when the new law would be implemented within the EU. Then, when COVID hit, and implementation of the law was delayed with a year, companies got Read More …
Category: MedTech
Exporting an Unapproved Investigational Device from the US in Support of a Clinical Trial in a Foreign Country.
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 …
MedTech Manufacturers, EU Distribution: Importer and Distributor Agreements (Part 2).
With the new MDR’s coming closer it becomes urgent for companies present in the EU market to sort all matter of distribution issues. The EU distinguishes several levels of economic actors: the Manufacturer, the Authorized Representative, the Importer and the Distributor, and each of these actors is now referred to in the Regulations. In this Read More …
MedTech Manufacturers, EU Distribution: Authorized Representative Agreements (Part 1).
With the new MDR’s coming closer it becomes urgent for companies present on the EU market to sort all matter of distribution issues. The EU distinguishes several levels of Economic Operators: Manufacturer, Authorized Representative (AR), Importer and Distributor. In this first article we will review the role of the Authorized Representative. The Authorized Representative Read More …
GB5D and SciMed Partners Announce Agreement to Collaborate
GB5D helps Companies Expand beyond Their Domestic Market The World Just Got a Little Bit Smaller SciMed Partners and GB5D have agreed to cooperate in order to better help foreign life sciences, medtech, and healthcare technology companies with US market entry. With several hundred years of combined biotech, medtech, life sciences, healthcare technology and international business Read More …
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 …
Should US MedTech companies be concerned about the new EU Medical Device Regulations?
The EU market has always been attractive for US MedTech companies. Obtaining approval to sell into the EU market has in the past always been easier than getting approval to sell in the US. That may soon change in view of the new EU Medical Device Regulations. For a long time, US manufacturers preferred to Read More …
Assess and Protect against Product Liability Claims when Entering a Foreign Market
When you enter a Foreign Market you will probably face a Product Liability regime different than the one in your home country (Similar But Still Separate and Distinct). Chances are your company is not intimately familiar with the risks in the market you plan to enter. Our experience has shown that “the unknown” can often 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 …