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.

Colombia Post Approval Regulations for In Vitro Diagnostic (IVD) Devices (All Classifications)

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.

Colombia Overview of Regulatory Framework for In Vitro Diagnostic (IVD) Devices

In 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.

Colombia Regulatory Roadmap & Technical Dossier Requirements for In Vitro Diagnostic (IVD) Devices (Category I & II)

The 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.

Colombia Regulatory Roadmap & Technical Dossier Requirements for In Vitro Diagnostic (IVD) Devices (Category II & III)

The 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.

Colombia Overview of Regulatory Framework for Medical Devices

Medical 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.

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.

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.

Why Gene Therapy Companies like Libella Gene Therapeutics are Looking at Colombia for their Clinical Trials?

Libella Gene Therapeutics —a US-based company— recently chose Colombia to conduct a phase I clinical trial that could represent a breakthrough in the treatment of Alzheimer's disease (AD) using gene therapy. The approval of a gene therapy trial in Colombia takes 30-45 days from the date of submission to an ethics committee. This time may be shorter or longer depending on how fast the ethics committee at the health institution (aka research center) evaluates the study documents. This positions Colombia as one of the countries with the fastest approval time (and lowest cost) in Latin America for gene therapy research.

How Can Medical Device Companies Avoid Being Taken Advantage of by a Distributor and Have Total Control over their Sales in Colombia

It is strongly recommended that foreign medical device manufacturers process the registration under their name and not under the local distributor name or else the foreign company will not be able to change or add distributors during the lifetime of the registration, which is 10 years.

9 Steps for Medical Device Companies to Register and Sell their Products in Colombia

Colombia has over 48 million residents and is a very strong market for foreign medical device manufacturers. Interested in entering this market? This article explains the process of obtaining regulatory approval from INVIMA, the country's regulator. Topics covered include regulations, classes of devices, appointing an independent representative, review times for the controlled and non-controlled products, and registration timelines.

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