Three Steps for a Medical Device Startup to Run a First-In-Human Clinical Trial in Colombia and Gather Quality Data at a Fraction of the Cost
Colombia'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.
Colombia's clinical trial regulatory agency —INVIMA (Instituto Nacional de Vigilancia de Medicamentos y Alimentos)— is a dependency of Colombia's Ministry of Health (MoH). The site's institutional review board (IRB)/ethics committee (EC) must first evaluate and approve the study, and then INVIMA.
Both the IRB 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).
These are the three main steps to get your medical device first-in-human clinical trial approved at a research site in Colombia:
IRB/EC: Submit your study documents to the local institutional review board (IRB) (known in Colombia as institutional ethics committee or "EC") at the clinical research site where you plan to conduct your trial. Each EC has its scheduling and processing times; some more efficient, predictable and faster than others. It takes about 15-45 days for a Colombian EC to approve a trial depending on how frequent they have their scheduled meetings. The EC's list of requirements is standard and usually follows INVIMA's requirements. An EC will require that you translate to Colombian Spanish all study documents before submission. Colombia's Ministry of Foreign Affairs (MoFA) has a rigorous exam-based certification process to vet local translators. Government agencies in Colombia prefer to see documents translated into Spanish by local MoFA-certified translators. It is advisable that you use the services of a local certified English-Spanish translator that is capable of translating your documents to the Colombian Spanish dialect (every country in Latin America has its way of speaking and writing Spanish).
INVIMA: Submit your study documents to INVIMA's Medical Device and In-Vitro Diagnostics Committee (Sala Especializada de Dispositivos Médicos y Reactivos de Diagnóstico In Vitro), along with the site's EC approval letter that you obtained in step 1 (see the requirements in Spanish here and in English here). INVIMA's Medical Device and Other Technologies Committee meets approximately every 30 days (see the meeting dates here). INVIMA will decide whether the protocol in question is approved or not and will issue its meeting minutes (acta, in Spanish) to notify the interested party (i.e., site, sponsor, CRO). See all meeting minutes here. Within the study submission approval application, the requester shall also include a clinical supply list (including the investigational device and all other necessary supplies and accessories) that you need to run the trial at the site of your choice. The requester must prove to INVIMA the presumed safety of the investigational device by doing device level tests (i.e., biocompatibility, strength test, corrosion test, traceability). It is up to the sponsor to prove to INVIMA the device's safety by providing as much documentation as the sponsor deems necessary. If the clinical trial sponsor is a foreign entity, it must appoint a local legal representative and importer of record in Colombia to submit its regulatory dossier package to INVIMA. Any contract research organization (CRO) in Colombia could act as the sponsor's legal representative (by power of attorney). The INVIMA approval will authorize the requester to start recruiting patient for its clinical trial, to conduct its clinical trial at a specific site with a specific investigator(s), and to import its investigational medical device.
VUCE: Submit to Colombia's Ministry of Commerce, Industry, and Tourism (MinCIT), VUCE office an application for an import permit. You will need proof of INVIMA's study approval (the acta in the step above) and a proforma invoice listing the investigational devices —and any other commercial devices, accessories, and supplies required in the clinical trial— that you plan to ship to your site in Colombia. You can ship at once all the items in your clinical supply list (previously approved by INVIMA in step 2 above) or make partial shipments. You will need one import permit for each shipment to Colombia. VUCE will check with INVIMA that the sponsor's legal representative in Colombia is indeed approved to import the investigational devices. VUCE takes about 5-10 business days to approve an import permit. More information about VUCE here.
About The Author
Julio G. Martinez-Clark is CEO of bioaccess, a U.S.-based contract research, regulatory, and market access consulting company focused on helping its clients conduct first-in-human clinical trials in Colombia and in the commercialization of their innovations in Latin America. Julio holds a bachelor’s degree in electrical engineering (B.S.E.E.), and a master’s degree in business administration (M.B.A.). Learn more.