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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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 activity…
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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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Biopharma perspectives 2021-24 with Trump or Biden

Biopharma perspectives 2021-24 with Trump or Biden

Business Development
By Juan Rivera-Mata, Markentry USA Partner The US elections may entail different scenarios for the biopharmaceutical industry. During his term, Trump has tried to eliminate “Obamacare” (a law that, among other things, makes it mandatory for companies to provide health insurance to their employees), and Biden has used that possibility as a main element of his campaign. But, at the same time as the President, local and state officials are also elected, and the House of Representatives and 1/3 of the Senate are renewed. It appears that Democrats will remain a majority in the House, but the Senate, now Republican, may go "blue." Trump has appointed 3 members of the Supreme Court - for life -, making it (6/3) conservative. The obligation to have health insurance (and any subsequent reform) will…
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How to open a company bank account in the US as a non-resident?

How to open a company bank account in the US as a non-resident?

Business
One of the first steps that foreign companies must take when launching their business in the US market is to open a bank account. This can be complicated when the company does not have employees residing in the country or does not have a permanent physical address, something that happens frequently at the beginning of an internationalization project and even in later phases. Many foreign-owned US companies are permanently managed by non-resident staff, with occasional support from a local representative.  The availability of a US bank account is of great importance for multiple reasons: It will make it easier to get local services and be paid for sales. For example, some online markets require the availability of a bank account in the US.It is an essential element when trying to…
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Trump vs Biden: impact on international trade

Trump vs Biden: impact on international trade

International Trade
By Gonzalo Garcia, Founder and CEO of Markentry USA CONTENTS 1. Introduction  2. Trump 3. Biden 4.Who is going to win? 5. Conclusions 5. Conclusions 1. Introduction Biden or Trump, Trump or Biden. We are just over two months away from the US presidential election. Its result will have a huge impact in all areas and will directly affect the plans of international companies and entrepreneurs with interests in the US market. Very few times in the history of presidential elections have we seen two candidates with such disparate visions of how the country should be led. This is especially relevant when the nation is in the largest recession since the Great Depression 90 years ago and in the middle of a serious health and social crisis caused worldwide by…
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USA: Status of international travel bans and immigration suspension

USA: Status of international travel bans and immigration suspension

Blog
By Gonzalo Garcia, Founder and CEO of Markentry USA CONTENIDOS 1. Introduction2. International travel bans3. Immigration suspension4. Availability of international flights5. Do travel bans make any sense?6. Forecast7. Conclusion7. Conclusión  1. Introduction The global crisis caused by COVID-19 has created countless problems for foreigners who resided or planned to reside in the United States and did not have US citizenship or permanent residence ("Green Card"), as well as for the companies that employed them or planned to. Immigration restrictions and travel bans imposed suddenly and unilaterally by the US administration in recent months have created situations of all kinds. It is difficult to estimate the number of people residing in the United States who have been indefinitely blocked outside the country, away from their families, their homes and their jobs. Those…
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