Frequently Asked Questions About Medical Device Early Feasibility (EFS) and First-In-Human (FIH) Studies (Clinical Trials) in Colombia

We 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.

FAQJulio G. Martinez-ClarkMay 16, 2018clinical trials, colombia, invimaComment

Frequently Asked Questions About Successful Latin America Market Entry Strategies for Medical Device Companies

There’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.

FAQJulio G. Martinez-ClarkMay 12, 2018medical devices, frequently asked questions, market entryComment

Frequently Asked Questions About Medical Device INVIMA Regulatory Registration, Legal Representation, and Importer of Record (IOR) in Colombia

Colombia'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.

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