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.
Read MoreNon-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.
Read MoreNon-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.
Read MoreManufacturers 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.
Read MoreMedical 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.
Read MoreThe 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.
Read MoreEmerging 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.
Read MoreOur product development and clinical experts have extensive experience in designing and conducting early stage healthcare technologies. We have the capabilities to offer a complete clinical testing and verification pathway from production ready prototype to acute and chronic animal experiments to first-in-man and feasibility clinical trials with the highest clinical research standard. We are familiar with the regulatory pathways and its overall impact in bringing a product to market.
Read MoreMedical 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.
Read MoreAccording to ClinicalTrials.gov, device trials have increased 94 percent from 2012 to 2017. The medical device contract research organization (CRO) market is expected to continue growing at 11.5 percent per year; at this rate, the market could reach nearly $13 billion by 2033.
Latin America has seen an explosive growth in medical clinical trials. According to ClinicalTrials.gov, out of the 35,780 global medical device trials conducted since 2000, 1,219 of them (or 3.4 percent) were registered in Latin America.
The same ClinicalTrials.gov data reveals that from 2000 to 2010, there were 255 medical device clinical trials in Latin America; there were 891 from 2011 to 2017 — an impressive 249 percent growth.
Read MoreLatin 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.
Read MoreThere’s no question that the medical equipment/devices market in Latin America is growing. Infusion pumps, dialysis equipment, prosthetic heart valves, and cardiac assist devices are projected to grow anywhere from 5% to nearly 14% a year between now and 2021. 25 medical device categories showed impressive gains in eight different countries during 2017. Why so much growth? It could be due to large changes in health conditions that are sweeping the region.
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