To market a medical device or IVD, manufacturers must register with the National Food and Drug Surveillance Institute (INVIMA), the country’s medical device regulator. With a four-tiered classification system, the classification scheme is very similar to those of the European Union. See an overview of the INVIMA approval process below or download the regulatory chart.
Overview of the regulatory process in Colombia
Medical Devices are governed by the Instituto Nacional de Vigilancia de Medicamentos y Alimentos (INVIMA). Determine the classification of your medical device according to Chapter II of Decree 4725/2005: Class I, Class IIa, Class IIb or Class III.
Before beginning the registration process, appoint a qualified Importer or Colombia Legal Representative who will submit your registrations to INVIMA. If you appoint an importer they may list themselves as the owner of the registration. If you appoint a Legal Representative, they will request Power of Attorney to manage your registration process, but you will retain ownership.*
Provide a Certificate of Free Sale (CFS) or Certificate to Foreign Government (CFG) to demonstrate that your device can be legally sold in your home market or Australia, Canada, the European Union, Japan or the US.
Provide proof of quality system compliance, such as an ISO 13485 certificate or proof of FDA QSR compliance. Prepare registration application dossier including detailed device information.
For Classes IIa, IIb, and III, provide test reports. Provide clinical data for Class IIb and III devices.
Your Importer or Colombia Legal Representative submits your application dossier to INVIMA and manages your medical device registration in Colombia. Documents must be submitted in Spanish. Pay application fee to INVIMA.
INVIMA automatically approves Class I and IIa applications, so you may begin selling right away. The agency will still review the application and manufacturers must respond to any additional information requests within 30 days. Failure to comply will result in approval being revoked.
For Class IIb and Class III devices, INVIMA must review and approve your application before you can begin selling; the review could take 4-6 months. During this review they may ask follow-up questions or request additional information.
Once approved, INVIMA will issue the registration certificate. Your registration certificate will be held by your Legal Representative or Importer in Colombia
You may begin marketing your device in Colombia. Registrations are valid for 10 years. For Class I and IIa devices, once INVIMA receives your application for renewal your registration will be automatically renewed. For Class IIb and III devices, application renewals are due to INVIMA three (3) months before the expiration of your registration certificate.
* Companies may appoint a Legal Representative in order to maintain control of the registration. However, irrespective of whether the registration is submitted via Legal Representative or not, the manufacturer must appoint a licensed importer in the registration. Registrations will not be accepted without a valid importer named.
This is a simplified overview of the process. INVIMA may choose to audit your submission and request more documents, which will add time to your approval.
Chart updated: 10/2016