Colombia - Regulatory Roadmap & Technical Dossier Requirements for Medical Devices (Low Risk: Class I and IIa)

Non-controlled Class I and lla devices are eligible for "automatic" registration. Controlled devices and Class IIb and III devices are subject to pre-market approval. The registration process for automatic approval of non-controlled Class I and lla devices 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.

Colombia - Regulatory Roadmap & Technical Dossier Requirements for Medical Devices (High Risk: Class IIb, III, and Controlled)

Non-controlled Class I and lla devices are eligible for "automatic" registration. Controlled devices and Class Mb and III devices are subject to pre-market approval. The device registration process for pre-market approval of Controlled devices and Class lib and III devices 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.

Colombia - Post Approval Requirements for Medical Devices (All Classifications)

Manufacturers must import their device 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. Medical device registrations with INVIMA are valid for 10 years. Renewals must be initiated at least 3 months prior to the registration expiration. INVIMA has the authority to inspect manufacturers and importers for compliance with medical device regulations. Manufacturers and importers are dually responsible for vigilance activities. Manufacturers and importers are required to submit a summary periodic report on a quarterly basis, even if no adverse events occurred.

Understanding Medical Device Regulation In Brazil

This article — the first in a two-part series — examines the current state of Brazil’s medical device regulation, clarifying the general registration and certification process that manufacturers, importers, and distributors need to follow to commercialize their devices freely. Part two analyzes Brazil’s medical device market, including patient demographics and challenges OEMS must overcome to succeed.

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