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?
Read MoreColombia's Ministry of Health (MoH) has one of the fastest regulatory approval times in Latin America: 30 days. The country also boasts a top-performing universal healthcare system that covers about 95% of its 50-million population and competitive hospital fees that are about 30-50% less than in the US or other Western European countries. The EC and INVIMA will evaluate the study protocol, the investigator's brochure, the patient informed consent form (ICF), the case report form (CRF), all information about the investigational product (e.g., biocompatibility tests, reports of unexpected adverse events), the study insurance policy, and all advertising material planned to recruit patients. You must also apply for an import permit at VUCE (Ventanilla Única de Comercio Exterior) —an office within Colombia's Ministry of Commerce, Industry, and Tourism (MinCIT).
Read MoreColombia 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.
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 MoreEl país debe fomentar un ambiente regulatorio ágil, predecible y eficiente para atraer del extranjero cada vez más estudios de investigación clínica con diferentes innovaciones médicas (medicamentos farmacéuticos y biológicos, biotecnología, dispositivos médicos, terapia génica, terapia celular, ingeniería de tejidos, etc.). Los actuales indicadores de rezago en el número de estudios de investigación clínica que se realizan en el país, presentan una oportunidad histórica para que Colombia haga los cambios normativos y administrativos necesarios para potencializar su industria de investigación clínica.
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 MoreWe can assist you with the search, site selection, and approval of planned first-in-human clinical trial in Colombia. We will review your site selection criteria and study goals. Then, we will search the 110+ clinical research sites in Colombia that are ICH-GCP (certified by Colombia's regulatory agency, INVIMA) to find the ideal site and principal investigator for your clinical trial. We will then get the study approved at the site's ethics committee, and then we will get it approved at INVIMA. The next step is to obtain an import permit approved so that you can ship your investigational medical products to your site in Colombia. Please be aware Colombian regulations prevent healthy volunteers from participating in Phase I trials; only sick patients with the disease related to the therapeutic area of your investigational products are allowed.
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.
Read MoreColombia's medical device market is regulated by the National Food and Drug Surveillance Institute (INVIMA). In order to market your device in Colombia, you must obtain sanitary registration from INVIMA.
INVIMA requires that your medical device is approved in a GHTF-founding member country (i.e., Australia, Canada, European Union, Japan, and the United States of America) or from a country that has an existing regulatory agreement of mutual recognition with Colombia.
Read MoreEl país debe fomentar un ambiente regulatorio ágil, predecible y eficiente para atraer cada vez más estudios de investigación clínica con diferentes innovaciones médicas (medicamentos farmacéuticos y biológicos, biotecnología, dispositivos médicos, terapia génica, terapía celular, ingeniería de tejidos, etc.). Los actuales indicadores de rezago del país presentan una oportunidad histórica para que Colombia haga los cambios normativos necesarios para estimular su industria de investigación clínica. Colombia tiene todo para convertirse en una potencia no solo regional sino mundial en el desarrollo de estudios clínicos. Esa es una de las principales conclusiones de un análisis que desarrolló recientemente la firma de investigaciones Pugatch Consilium. El análisis estima que Colombia podría generar hasta USD 500 millones en inversión extranjera directa si se hacen los cambios necesarios en el país.
Read MoreSe trata de un ensayo clínico en único centro, abierto, en donde se evaluará la seguridad, eficacia y actividad del AAV-Htert administrado por vía Intratecal (IT) (Tratamiento A) o vía intravenosa (IV) (tratamiento B). Se realizará una evaluación de la actividad de la terapia AAV-Htert para establecer una dosis proporcional, además de recopilar información sobre la seguridad de los pacientes, así como cambios en el estado basal de la EA. Se incluirán sujetos entre los 40 y 100 años inclusive quienes recibirán uno de los dos tratamientos al inicio del estudio. Los sujetos se evaluarán clínicamente por un año, asistirán a 10 visitas en total incluida la visita de tamizaje y serán evaluados de manera posterior después de finalizar el estudio, mediante chequeos anuales de seguridad para evidenciar eventos adversos tardíos.
Read MoreLibella Gene Therapeutics —a US-based company— recently chose Colombia to conduct a phase I clinical trial that could represent a breakthrough in the treatment of Alzheimer's disease (AD) using gene therapy. The approval of a gene therapy trial in Colombia takes 30-45 days from the date of submission to an ethics committee. This time may be shorter or longer depending on how fast the ethics committee at the health institution (aka research center) evaluates the study documents. This positions Colombia as one of the countries with the fastest approval time (and lowest cost) in Latin America for gene therapy research.
Read MoreForeign 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.
Read MoreIt 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.
Read MoreColombia 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.
Read MoreEl Instituto Nacional de Vigilancia de Medicamentos y Alimentos (INVIMA) es la entidad autorizada por el Ministerio de Salud y Protección Social para evaluar y aprobar proyectos de investigación clínica con medicamentos y dispositivos médicos en seres humanos en Colombia. La Sala Especializada de Dispositivos Médicos y Reactivos de Diagnóstico In Vitro del INVIMA evalúa solicitudes de aprobación de estudios de investigación clínica aproximadamente cada 30 días; esto hace que el país sea uno de los más competitivos de Latinoamérica para este tipo de estudios. Sin embargo, llegó el momento de crear una ley de investigación en clínica en humanos clara, moderna y competitiva que garantice que Colombia se convierta en uno de los países más innovadores en salud de América Latina para el 2025.
Read MoreColombia offers unparalleled benefits to pharma, medtech & biotech startups looking for a place to conduct their clinical trials with fast regulatory approval, ample access to patients, and very competitive costs.
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