Posts in Market Access
Latin America Offers Welcoming Entry Market Amid Tighter EU Regulations

In the past, regulatory requirements that were laxer than U.S. rules made the EU almost a no-brainer as an entry market for many medtechs. However, the advent of the MDR and IVDR has tightened EU regulations and added implementation challenges. Are Latin American markets the answer?

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What Medtech Companies Need to Know About Colombia's Growing Medical Device Market

Colombia has successfully positioned itself as the third largest medical devices market in Latin America, after Brazil, and Mexico. Business Monitor International forecasts indicate that Colombia is projected to stay in this rank for 2022. This is the product of the dynamism of the medical device sector in Colombia. This segment has presented average annual growth rates between 2014 and 2017 of 18% in local currency (COP) and of 7,9% in USD. The capital city, Bogota, D.C., represents 75% of total sales of medical devices in the country. 

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Why do Medtech Companies Need a Market Access Plan in Latin America?

Emerging markets are the engines of growth today, and, thus, performing in these markets is critical for the majority of pharmaceutical and medical technology companies. Market access has gained considerable attention worldwide as countries try to contain their escalating healthcare expenditures amidst the global economic slowdown. This has resulted in governments adopting stricter measures for new product approval. Thus, pharmaceutical and medical technology companies are finding it increasingly difficult to successfully address the specific challenges posed by various government and regulatory agencies and stakeholders.

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The World’s Scariest — And Most Promising — Medical Device Market

Medical device imports in Mexico — which boasts a population of about 130 million, claimed a GDP of US$1.15 trillion in 2017, and embraces Spanish as its official language — were about $4.8 billion in 2017.(10,2) This article analyzes the current medical device market in Mexico and its potential. There is heavy competition on the Mexican medical device market, it is not exactly well-regulated, and innovation is unstable, but it still is expected to grow.

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How can Medical Device Companies Access the Latin American Market to Increase Sales and Achieve Long-Term Growth

Latin America is developing into that sizable, predictable part of the world market of medical devices. The region has developed into predictable, flourishing healthcare markets that would allow foreign manufacturers to have sustainable commercial operations. The Latin American market for medical devices and equipment is worth approximately an impressive US$30 billion.

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How Can Medical Device Companies Find a Distributor to Increase Sales and Growth in Latin America

Foreign manufacturers that have been involved in penetrating new overseas markets understand that finding the right distributor is a challenge. Most relationships that initially seemed promising, begin to deteriorate when the distributor doesn't meet its sales goals. In most cases, these misalignments can be avoided through careful and professional due diligence and planning. The problem is that most medical device manufacturers don't have the time or experience to do it well.

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How Can Medical Device Companies Avoid Being Taken Advantage of by a Distributor and Have Total Control over their Sales in Colombia

It is strongly recommended that foreign medical device manufacturers process the registration under their name and not under the local distributor name or else the foreign company will not be able to change or add distributors during the lifetime of the registration, which is 10 years. 

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9 Steps for Medical Device Companies to Register and Sell their Products in Colombia

Colombia has over 48 million residents and is a very strong market for foreign medical device manufacturers. Interested in entering this market? This article explains the process of obtaining regulatory approval from INVIMA, the country's regulator. Topics covered include regulations, classes of devices, appointing an independent representative, review times for the controlled and non-controlled products, and registration timelines.

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