Keys for the Commercialization of Medical Devices in the US

Keys for the Commercialization of Medical Devices in the US

Laws and regulations
By Maria Jose Lopez Barragan, Ph.D. Markentry USA Partner and Juan Rivera-Mata, Ph. D. Markentry USA Partner Many companies plan their entry into the American market without a good understanding of the legal requirements that govern their products in the US. The FDA (Food and Drug Administration) regulates the consumption not only of drugs and food, but also of veterinary products, cosmetics, tobacco, and so-called “medical devices”.About one-fifth of what American consumers spend is, in one way or another, regulated by the FDA Under the category of medical devices there is a wide variety of products that ranges from complex devices that assist robotic surgery or even artificial organs, to objects that accompany our daily lives and whose perception can be very different from what anyone would consider a medical…
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How to Ensure your International Company Website is Effective in the US

How to Ensure your International Company Website is Effective in the US

Business Development
Introduction At this point, it should be unnecessary to explain why taking care of the online presence of a business is essential if you want to succeed in any market in the world, with very few exceptions. However, it is surprising the high number of errors that can be identified when reviewing the web pages of international companies that are devoting large amounts of resources to entering the US market. In this article we will identify the most frequent problems and propose some ways to solve them.Think Globally, Act LocallyIn a global or international strategy, it is essential to know the details that must be adapted for important markets. The United States is a country with special characteristics that may lead to the need for not obvious modifications in the message…
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Immigration and Travel to the US: Update

Immigration and Travel to the US: Update

Blog
End of immigration suspension Unsurprisingly, quietly and with little media attention, the restrictions on the issuance of nonimmigrant visas H-1B, L-1 and J-1, which had been in force since June 24, 2020, expired on March 31st. Since then, US consulates around the world have restarted the issuance of H-1B, L-1 and J-1 visas without the need for an additional request for a national interest exception. This joins the elimination of the suspension on immigrant visas or 'Green Cards' ordered by President Biden on February 24 and that we already discussed in our article Important news about immigration to the US. Therefore, US consulates have restarted the processing of visas that had been blocked and have started accepting new visa applications. It is expected that it will take some time before consular…
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7 Highlights from my Conversation with two Ambassadors on the Biden Era

7 Highlights from my Conversation with two Ambassadors on the Biden Era

Blog
By Gonzalo García, Founder and CEO of Markentry USA Last Wednesday, April 21st, I had the pleasure of hosting a webinar on behalf of the US Spain Executives Community with the title ''Biden Era, Impact on US Spain relations". We had the privilege of talking with Spain's Ambassador to the US, Santiago Cabanas, and former US Ambassador to Spain, Alan Solomont. You can find a full description of the webinar, their bios and the complete video at the event web page. The purpose of the webinar was to discuss the changes derived from the transition to the new Biden Administration and its impact on the bilateral relations between Spain and the US. It focused on economic and business aspects, including topics like multilateralism, immigration, trade, tariffs, business opportunities and other areas. Even though…
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Suspension of the tariffs between the US and the EU derived from disputes over public aid to Boeing and Airbus

Suspension of the tariffs between the US and the EU derived from disputes over public aid to Boeing and Airbus

Business
In a joint statement on March 5th, the US and the European Union have agreed to an immediate suspension of the tariffs that had arisen as a result of disputes associated with public aid to Boeing and Airbus. A similar agreement between the US and the UK was announced the prior day.These conflicts, managed within the framework of the World Trade Organization (WTO), had led to the authorization by WTO of tariffs on a wide range of products from both sides. This confirms the expectations we had explained in our recent article The Biden Era is Coming: Impact on Companies International and in which we said "It is to be hoped that the new administration will resume international collaboration within the framework of the World Trade Organization and seek ways to end…
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Important news about immigration to the US

Important news about immigration to the US

Blog
On February 24, President Biden signed a Proclamation in which he cancelled some of the limitations on immigration imposed by the previous president Trump. Essentially, the impact of this order is to revoke the following restrictions: Presidential Proclamation 10014 of April 22, 2020, which established a general suspension of the issuance of new immigrant visas (understood as permanent residence permits or 'Green Cards'), with some exceptions.Section 1 of the Presidential Proclamation 10052 of June 22, 2020, which extended the previous one until December 31 2020Section 1 of the Presidential Proclamation 10131 of December 31, 2020, which extended the previous one until March 31 2021Therefore,  the door opens again for the issuance of new permanent residence permits or 'Green Cards' for people who meet the associated requirements. It is important to note that…
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Seven deadly sins in US market entry

Seven deadly sins in US market entry

Business
By Gonzalo Garcia, Founder and CEO of Markentry USA CONTENTS Introduction  1. Not adapting the 4 Ps of the ‘marketing mix’ to the target market 2. Ignoring regional differences or acting in the wrong state 3. Landing without the local support of experts in the target market 4. Acting without a subsidiary or choosing an inappropriate structure for it 5. Designing a complex and rigid business plan 6. Underestimating costs and deadlines 7. Underestimating the impact the US can have on the business Conclusion Conclusion Introduction The challenge faced by international companies and foreign entrepreneurs when trying to enter the US market is as great as the payoff obtained from succeeding. We are talking about a market of 330 million people with a per capita income of $65,000, which being…
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The Biden Era Begins: Impact on International Companies

The Biden Era Begins: Impact on International Companies

Business
By Gonzalo Garcia, Founder and CEO of Markentry USA CONTENTS 1. Introduction  2. Biden's real ability to drive meaningful change 3. Biden's priorities 4. People appointed to key positions 5. International trade 6. Immigration and travel bans 7. Opportunities for international companies 8. Conclusions 5. Conclusions 1. Introduction The inauguration of Joe Biden as President of the United States on January 20 represents a radical change of course with respect to what has been the period led by Donald Trump. Without a doubt, it is going to have a significant impact on international companies that compete or want to compete in the US market, which we will analyze in detail in this article.We will study the depth of the expected changes, taking into account the nuances of the US political…
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How to transfer money (legally) to the US

How to transfer money (legally) to the US

Blog
We describe the factors to take into account when transferring money to the US as well as the existing options, their advantages, disadvantages and risks, recommending the optimal method for every situation. Index IntroductionFactors to considerOPTION 1: Travel with cash OPTION 2: Use of debit cards from the country of origin to get cash from ATMs in the USOPTION 3: Use of credit cards from the country of origin for payments in the USOPTION 4: Bank wire transferOPTION 5: Independent online platformsOPTION 6: Currency brokersTaxes and reporting obligationsConclusions and recommendationsConclusiones y recomendaciones Introduction A problem that all international entrepreneurs, executives and professionals face when settling in the US is finding the optimal way to transfer money to this country. We refer both to the money used by individuals to cover their…
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COVID-19: Is the vaccine safe? Should I get it? – Perspectives from the US

COVID-19: Is the vaccine safe? Should I get it? – Perspectives from the US

Blog
Given the evolution of the pandemic and the news about vaccines, many of us may be asking ourselves these questions right now, which we will try to answer with a double approach: technical and social, individual and collective. Is the vaccine safe? By María José López Barragán, Ph.D. Markentry USA Partner Despite the deep concern for our physical and mental health and for the economic situation, many citizens confess not wanting to be vaccinated, now that we almost touch the first version of that coveted vaccine with our fingers. The main concern: side effects. Nobody wants to be "first." These beliefs reflect a significant gap in the information that is distributed each day. Society is bombarded with efficacy data (70%, 90%, 95%, 96%) and technical details (RNA, DNA, attenuated viruses, viral…
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