Foreign Medical Devices Need a Clear Path to Enter Mexico

Q: What is the main added value that Medisi brings to the Mexican market?
A: Our 44-year-old company serves as a gateway for foreign businesses, allowing them to enter Mexico and operate in various sectors. We act as facilitators. We focus on helping mid-range devices, which are in demand globally, enter the Mexican market. We also help SMEs enter the Mexican market. Mexico is not an easy market to navigate but Medisi has stood the test of time, offering the support necessary to enter the Mexican market with confidence. Medisi helps the client who through us can import, sell, and form partnerships that will enable him to navigate the different distribution networks. This system is crucial because Mexico is a country of distribution. Big companies do not sell directly; they rely on a broad network of distributors and sub-distributors. In this landscape, we offer comprehensive support that goes beyond simple logistics. We facilitate entry into a market that, despite its challenges, offers large opportunities. The socio-cultural and linguistic barriers can be daunting, but our experience and infrastructure make all the difference.

Q: How does the political tension between Mexico and the United States affect the Mexican medical device industry?
A: US President Donald Trump’s administration seems to be pushing strongly, but so far, has been careful not to harm the USMCA and has also collaborated with P. Sheinbaum. So far, there has been no real change beyond the uncertainty that the tariffs generate among companies worldwide. The true concern lies in how tariffs could impact US businesses looking to enter the Mexican market. If they neglect the country, they risk losing opportunities. Another concern is the border: companies in Mexico and the United States rely on the Mexico-US supply chain for importing, unfinished parts that are to become finished goods in USA. The real impact of tariffs will be felt by these factories, which could face increased cost and might end up removing products from the market. This could open the gate for players from countries like Germany and China. Yet the supply of American products is so well established that only the final patient will be the one to face consequences. The major medical device players are already in Mexico, and have made significant investments that cannot be easily moved in the short to medium term. They are likely to weather the storm. While the situation is creating uncertainty, the established systems worldwide are so intertwined that any major disruptions would affect the people these tariffs are meant to protect.

Q: What are your expectations for Mexico's current administration?
A: We hope that this administration addresses what truly matters, rather than reacting to what is urgent. Healthcare in Mexico is critically important, and it has become a central focus in the health plan issued by Minister of Health David Kershenobich. This plan emphasizes strengthening first-level care and improving infrastructure, but it does not clarify details on consolidated purchases. The data on consolidated purchases from the previous administration reveals concerning trends. Over the past six years, there were a few significant consolidated purchases, but the majority of transactions involved direct awards, which are problematic. Most states and federal institutions resort to purchasing independently each month due to urgent needs, creating a cycle of inefficiency and corruption.

Q: What changes have you observed in COFEPRIS’s operations and how are you navigating them?
A: We are observing an increase in answers that go against all past experiences, often with no explanation. There is a lack of transparency and accountability fueled by a complete denial to have one-on-one official talks with COFEPRIS reviewers. As a result, it becomes impossible to appeal or solve efficiently misunderstandings of the information provided. Dealing with these issues has always been complex, but it now demands an extraordinary level of foresight when it comes to the quality of the dossier. The focus has shifted from registering products based on the benefit they will provide to patients to focusing on the "packaging" of the dossier. This harms the healthcare system and the country.

Q: What are Medisi’s commitments to the Mexican patients?
A: Medisi operates with integrity, choosing the best products in their respective categories. We propose solutions and foster education. That is our primary objective. We consistently seek webinars, conduct networking, and share information to help others become better prepared. Sometimes, international stakeholders need guidance to understand Mexico. Our commitment lies in educating, acting with integrity, and following through.

Medisi America is the first Mexican consultancy specializing in medical devices. It has become a leading regulatory consolidator in Latin America and the United States.