Peru's Growing Medical Device Market In Latin America

Peru is the fifth-largest economy in #latinamerica after Brazil, Mexico, Argentina, and Colombia. The size of the Peruvian #medicaldevice market is $390 million, and Peru imports more than 97 percent of the medical devices that it uses. This article discusses why, despite the pandemic's effects on Peru's health and economy, the country offers business opportunities for foreign manufacturers of medical devices. I will cover the country's health system, its regulatory framework, opportunities for medical device imports, and an outlook of doing business in the country going forward.

Market AccessJulio G. Martinez-ClarkApril 4, 2022peru, DIGEMIDComment

The Large Market For Medical Devices In Colombia May Surprise You

This article discusses why Colombia, despite the global effects of the COVID-19 pandemic, has become the country with the best commercial advantages in South America and one of the three best in Latin America for foreign medical device manufacturers to market their innovations. We will cover the general Colombian health social security system (coverage, affiliation, and forms of financing); the current medical device regulatory framework, including the short marketing authorization times compared to other countries in the area, and the size and trends of the market.

Market AccessJulio G. Martinez-ClarkMarch 21, 2022Colombia, INVIMAComment

Argentina's Thriving Medical Device Market Amid An Economic Plunge

This article aims to describe the Argentine healthcare system and the capacity of its hospital network. Additionally, it analyzes the organizational, functional, and regulatory characteristics of the Argentinian regulatory framework for medical devices and its relationship with the Mercado Común del Sur (Common Market of the South, Mercosur). Lastly, it concludes with the business opportunities and challenges that the Argentine device market currently represents, considering its macroeconomic and social conditions.

Market AccessJulio G. Martinez-ClarkAugust 20, 2021Argentina, ANMATComment

Medtech In Chile: Currently Latin America's Easiest Market, But For How Long?

This article provides an overview of the regulatory framework and the opportunities Chile represents for medtech companies looking to quickly and cost-effectively enter Latin America without regulatory barriers and with access to a robust private payor insurance system modeled after the U.S. healthcare system.

Colombia - Regulatory Roadmap & Technical Dossier Requirements for Medical Devices (Low Risk: Class I and IIa)

Non-controlled Class I and lla devices are eligible for "automatic" registration. Controlled devices and Class IIb and III devices are subject to pre-market approval. The registration process for automatic approval of non-controlled Class I and lla devices will require the following steps: 1. Appoint local representative through power of attorney. 2. Ensure documents provided by the manufacturer are compliant with INVIMA requirements. 3. Compile the technical submission in Spanish (or at least Spanish summaries of test reports). 4. Provide product certifications and manufacturer's testing methodology. 5. File the application with INVIMA. 6. Receive automatic approval upon complete submission (within 2-4 days). 7. Begin marketing. 8. INVIMA will conduct a post-submission review.

Colombia - Regulatory Roadmap & Technical Dossier Requirements for Medical Devices (High Risk: Class IIb, III, and Controlled)

Non-controlled Class I and lla devices are eligible for "automatic" registration. Controlled devices and Class Mb and III devices are subject to pre-market approval. The device registration process for pre-market approval of Controlled devices and Class lib and III devices will require the following steps: 1. Appoint local representative through power of attorney. 2. Ensure documents provided by the manufacturer are compliant with INVIMA requirements. 3. Compile the technical submission in Spanish (or at least Spanish summaries of test reports). 4. Provide product certifications and manufacturer's testing methodology. 5. File the application with INVIMA.

Colombia - Post Approval Requirements for Medical Devices (All Classifications)

Manufacturers must import their device within the first 3 years of approval, or INVIMA can cancel the registration. Only licensed importers can import medical devices into Colombia. Importers must be identified in the device registration. Medical device registrations with INVIMA are valid for 10 years. Renewals must be initiated at least 3 months prior to the registration expiration. INVIMA has the authority to inspect manufacturers and importers for compliance with medical device regulations. Manufacturers and importers are dually responsible for vigilance activities. Manufacturers and importers are required to submit a summary periodic report on a quarterly basis, even if no adverse events occurred.

Colombia Post Approval Regulations for In Vitro Diagnostic (IVD) Devices (All Classifications)

Manufacturers must import their IVD within the first 3 years of approval, or INVIMA can cancel the registration. Only licensed importers can import medical devices into Colombia. Importers must be identified in the device registration. Class I and Il IVD registrations are valid for 10 years. Class Ill IVD registrations are valid for 5 years. Renewal applications should be initiated 6 months prior to registration expiration.

Colombia Overview of Regulatory Framework for In Vitro Diagnostic (IVD) Devices

In Vitro Diagnostic (IVD) reagents are regulated by the Instituto Nacional de Vigilancia de Medicamentos y Alimentos (National Food and Drug Surveillance Institute, or INVIMA) in Colombia. The regulatory framework for IVD reagents is based on Decree 3770/2004, amended by Decree 4124/2008 and Decree 581/2017. Other IVD devices (e.g., instruments or analyzers) fall under the conventional medical device regulatory framework of Decree 4725/2005. All IVD reagents require registration with INVIMA. An "automatic registration" pathway is available for low risk (Class I and Il) MDs, whereby registration is automatically granted upon submission of required documents. Class Ill IVDs require pre-market approval and may require additional approval from the Specialized Board for IVDs.

Colombia Regulatory Roadmap & Technical Dossier Requirements for In Vitro Diagnostic (IVD) Devices (Category I & II)

The registration process for automatic approval of category I and Il IVDs will require the following steps: 1. Appoint local representative through Power of Attorney. 2. Ensure documents provided by the manufacturer are compliant with INVIMA requirements. 3. Compile the technical submission in Spanish (or at least Spanish summaries of test reports). 4. Provide product certifications and manufacturer's testing methodology. 5. File the application with INVIMA. 6. Receive automatic approval upon complete submission (within 2-4 days). 7. Begin marketing. 8. INVIMA will conduct a post-submission review. Answer any questions that INVIMA may ask regarding the registration (responses must be submitted within 30 working days of the request). 9. Make any legal and technical revisions of the application, if required by INVIMA. 10. Maintain post-market obligations.

Colombia Regulatory Roadmap & Technical Dossier Requirements for In Vitro Diagnostic (IVD) Devices (Category II & III)

The registration process for pre-market approval of category Ill IVDs will require the following steps: 1. Appoint a local representative through a power of attorney. 2. If IVD has no valid certificate of free sale (CFS) from recognized reference countries, obtain technical approval from the Specialized Board, according to the requirements in Article 7 of Decree 3770/2004. 3. Ensure documents provided by the manufacturer are compliant with INVIMA requirements. 4. Compile the technical submission in Spanish (or at least Spanish summaries of test reports). 5. Provide product certifications and manufacturer's testing methodology. 6. File the application with INVIMA. 7. Answer any questions that INVIMA may ask regarding the application (responses must be submitted within 90 working days of the request). 8. Make any legal and technical revisions of the application, if required by INVIMA. 9. Upon approval, begin marketing. 10. Maintain post-market obligations.

Brazil's Medical Device Market: Patient Demographics, Healthcare System, And Outlook

This article — the second in a two-part series — analyzes Brazil’s medical device market, including patient demographics and challenges that manufacturers, importers, and distributors need to understand and/or overcome to commercialize their devices freely. Part one in the series examines the current state of Brazil’s medical device regulation, clarifying the general registration and certification process.

Colombia Overview of Regulatory Framework for Medical Devices

Medical devices are controlled by the National Food and Drug Surveillance Institute (INVIMA - institute National de Vigilancio de Medicarnentos y Alimentos] in Colombia. The regulatory framework is based on Decree 4725/2005 (and amendments). Other medical device regulatory documents are available on the INVIMA website. Products that meet the characteristics of a medical device must be registered with INVIMA prior to commercialization. An "automatic registration" pathway is permitted for low-risk devices, whereby registration Is automatically granted upon submission of required documents. High-risk devices are subject to pre-market approval.

Understanding Medical Device Regulation In Brazil

This article — the first in a two-part series — examines the current state of Brazil’s medical device regulation, clarifying the general registration and certification process that manufacturers, importers, and distributors need to follow to commercialize their devices freely. Part two analyzes Brazil’s medical device market, including patient demographics and challenges OEMS must overcome to succeed.

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?

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.

Market AccessJulio G. Martinez-ClarkFebruary 27, 2019Colombia, medical device marketComment

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.

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.

Market AccessJulio G. Martinez-ClarkNovember 19, 2018mexico, market access plan, market research, market entry, medical devices, cofeprisComment

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.

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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