Manufacturers must import their IVD 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. Class I and Il IVD registrations are valid for 10 years. Class Ill IVD registrations are valid for 5 years. Renewal applications should be initiated 6 months prior to registration expiration.
Read MoreIn Vitro Diagnostic (IVD) reagents are regulated by the Instituto Nacional de Vigilancia de Medicamentos y Alimentos (National Food and Drug Surveillance Institute, or INVIMA) in Colombia. The regulatory framework for IVD reagents is based on Decree 3770/2004, amended by Decree 4124/2008 and Decree 581/2017. Other IVD devices (e.g., instruments or analyzers) fall under the conventional medical device regulatory framework of Decree 4725/2005. All IVD reagents require registration with INVIMA. An "automatic registration" pathway is available for low risk (Class I and Il) MDs, whereby registration is automatically granted upon submission of required documents. Class Ill IVDs require pre-market approval and may require additional approval from the Specialized Board for IVDs.
Read MoreThe registration process for automatic approval of category I and Il IVDs 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. Answer any questions that INVIMA may ask regarding the registration (responses must be submitted within 30 working days of the request). 9. Make any legal and technical revisions of the application, if required by INVIMA. 10. Maintain post-market obligations.
Read MoreThe registration process for pre-market approval of category Ill IVDs will require the following steps: 1. Appoint a local representative through a power of attorney. 2. If IVD has no valid certificate of free sale (CFS) from recognized reference countries, obtain technical approval from the Specialized Board, according to the requirements in Article 7 of Decree 3770/2004. 3. Ensure documents provided by the manufacturer are compliant with INVIMA requirements. 4. Compile the technical submission in Spanish (or at least Spanish summaries of test reports). 5. Provide product certifications and manufacturer's testing methodology. 6. File the application with INVIMA. 7. Answer any questions that INVIMA may ask regarding the application (responses must be submitted within 90 working days of the request). 8. Make any legal and technical revisions of the application, if required by INVIMA. 9. Upon approval, begin marketing. 10. Maintain post-market obligations.
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 MoreEl tiempo que toma aprobar un estudio en un país tiene cuatro variables externas. La primera es la búsqueda del investigador principal y el hospital donde se piensa realizar el estudio. La segunda es el tiempo de aprobación del comité de ética del hospital. La tercera es el tiempo de aprobación en la agencia regulatoria del país, y la cuarta es el tiempo de aprobación del permiso de importación de los dispositivos en investigación.
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 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 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.
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