Posts in Colombia
LATAM's Regulatory Framework For Medtech Early Feasibility Studies
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.

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Clinical Research, Clinical Trial, Investigación clínica, ColombiaJulio G. Martinez-Clarkearly stage clinical trial, early feasibility clinical trial, first-in-human, first-in-man, medical device clinical trial, regulatory frComment
4 Time Variables that a Medical Device Company Must Evaluate to Start a First-In-Human Medical Device Clinical Trial in Colombia
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.

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Colombia, Clinical Trial, Clinical Research, INVIMAJulio G. Martinez-Clarkfirst-in-man, first-in-human, medical devices, colombia, early stage clinical trial, early feasibility clinical trialComment
Proyecto de ley para fomentar la investigación clínica y lograr que Colombia reciba USD $500 millones en inversión extranjera de servicios de investigación clínica en el 2030
Proyecto de ley para fomentar la investigación clínica y lograr que Colombia reciba USD $500 millones en inversión extranjera de servicios de investigación clínica en el 2030

El 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.

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Colombia, Legislación en Colombia, INVIMA, Investigación clínicaJulio G. Martinez-Clarkinvestigación clínica, investigacion clinica, estudios clinicos, colombia, exportación de serviciosComment
How Can Medical Device Companies Avoid Being Taken Advantage of by a Distributor and Have Total Control over their Sales in Colombia
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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Market Access, Regulatory, INVIMA, ColombiaJulio G. Martinez-Clarkcolombia medical, device register, colombia timeline, colombian timeline, timeline of colombia, colombian medical device approval, medical device registration colombia, device registration, regulatory process, regulatory representation, regulatory consulting, device regulations, papers regulations, category device, country representation, representation regulatory, legal representativeComment
9 Steps for Medical Device Companies to Register and Sell their Products in Colombia
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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Market Access, Regulatory, INVIMA, ColombiaJulio G. Martinez-Clarkmedical device registration colombia, colombia medical, device register, colombia timeline, colombian timeline, timeline of colombia, colombian medical device approval, device registration, regulatory process, regulatory representation, regulatory consulting, device regulations, papers regulations, category device, country representation, representation regulatory, legal representativeComment