LATAM's Regulatory Framework For Medtech Early Feasibility Studies

U.S. medtech companies are increasingly searching for a destination where they can recruit patients faster, easier, and cheaper for their early feasibility studies. Medtech companies want to avoid the uncertainty of the FDA Investigational Device Exemption (IDE) review process. Due to the new European Medical Device Directive (MDR) 's difficulties since May 2021, the medtech clinical trial pendulum is shifting from Eastern Europe to Latin America. Many more medtech companies are now looking at Latin America as their destination for their early feasibility research instead of Eastern Europe.

Latin America's Landscape For Medtech Clinical Trials

This article examines the need to conduct medtech clinical trials outside the U.S. and explores the growth of these trials in Latin America, particularly in Colombia and Paraguay. I will address critical success factors and provide recommendations to ensure cost-effective, ethical, and quality EFS and FIH medtech clinical trials in the region.

The Opportunities For Conducting Vaccine Clinical Research In Latin America

This article discusses the 101-year history of vaccine research in Latin America, how Latin America could help solve the vaccine clinical trial diversity problem in the U.S., and why the region is a desirable destination for such clinical research.

Latin America: A Compelling Region To Conduct Your Clinical Trials

This article examines the need to conduct clinical trials outside the U.S. (OUS), addresses the recruitment crisis in the U.S., reviews the incentives for clinical trials overseas, and explores the growth of clinical trials in Latin America. We will profile Colombia as an example of a country committed to attracting more foreign investment in clinical trials.

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.

4 Time Variables that a Medical Device Company Must Evaluate to Start a First-In-Human Medical Device Clinical Trial in Colombia

The time it takes to approve a clinical research study in Colombia has four main variables. The first is the search for the principal investigator (PI) and his/her associated hospital where he/she practices and has the right patient population (aka IPS in Colombia). The second is the approval time of the ethics committee associated with the IPS. The third is the approval time in the regulatory agency (INVIMA), and the fourth is the approval time of the import permit of the devices under investigation (VUCE). In this blog post, we will explain the reason why the selection of the principal investigator is really what could make a study successful or not.

4 variables de tiempo que una empresa de dispositivos médicos debe evaluar para comenzar un estudio de investigación clínica en Colombia

El tiempo que toma aprobar un estudio en un país tiene cuatro variables externas. La primera es la búsqueda del investigador principal y el hospital donde se piensa realizar el estudio. La segunda es el tiempo de aprobación del comité de ética del hospital. La tercera es el tiempo de aprobación en la agencia regulatoria del país, y la cuarta es el tiempo de aprobación del permiso de importación de los dispositivos en investigación.

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