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.
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