Key medical device and IVD regulations in Colombia
Medical devices in Colombia are regulated by the National Food and Drug Surveillance Institute (INVIMA). INVIMA oversees the regulation of medical devices and IVDs, as well as foods, drugs, pharmaceutical, and biological products. Before you can legally distribute your medical device or IVD in Colombia, you must submit a health registration application to INVIMA for approval.
INVIMA enforces requirements in the two primary health regulations:
- Decree 4725/2005 outlines the regulatory framework for medical devices.
- Decree 3770/2004 outlines the regulatory framework for IVDs.
INVIMA medical device classification is nearly identical to the classification scheme for medical devices in Europe under the EU Medical Devices Regulation (MDR). Medical devices are classified into four levels according to their risk profile: Class I, Class IIa, Class IIb, Class III.
INVIMA Colombia medical device regulatory process
There are two registration pathways for medical devices in Colombia: uncontrolled and controlled. Uncontrolled devices, which includes Classes I and IIa, are eligible for automatic approval from INVIMA following submission of a complete registration application. Class IIb and III devices are controlled, and INVIMA will conduct a review of your registration documentation before approval.
Detailed technical documentation, including design and manufacturing information, clinical data, risk assessments, and labeling documentation, must be submitted as part of the registration dossier to demonstrate compliance. Here is a high-level overview of INVIMA's documentation requirements:
- Legal Representative located in Colombia (for foreign device companies)
- Certificate of Free Sale (CFS) or Certificate to Foreign Government (CFG) from the country of origin or acceptable reference market (Australia, Canada, Japan, Europe, or the United States)
- Proof of quality management system, such as an ISO 13485 certificate
- Technical documentation, clinical data, test reports, etc. as appropriate for your device classification.
Your registration materials must be submitted in Spanish.
UDI Requirements in Colombia
Colombia introduced a semantic reporting process and UDI-DI requirements with the implementation of Resolution 1405 of 2022 (link in Spanish). This resolution mandates the use of Unique Device Identifier – Device Identifier (UDI-DI) codes for product identification and traceability and recognizes codes issued by globally accepted organizations, including GS1, HIBCC, ICCBBA, IFA, Ali Health, and ZIIOT in line with global UDI standards.
INVIMA launched a web platform to support this new process and now requires sanitary registration holders to submit a semantic report that that includes basic, regulatory, and commercial attributes of the device. To complete the reporting process, registration holders must first secure INVIMA approval and obtain UDI-DI codes from certified agencies for the device, then submit the report via INVIMA’s platform and pay a fee. The registration holder is responsible for completing the report, but manufacturers must supply the UDI-DI codes.
The regulation is now in force and compliance is mandatory for all new and existing sanitary registrations, except for Class IIa, Class I, and Category I IVDs, which must comply by February 8, 2026.
Helpful resources for COFEPRIS medical device registration
As you begin planning to market your device in Colombia, here are some resources that will be useful along the way:
- INVIMA: Colombia’s medical device and IVD regulatory authority.
- Decree 4725/2005: Colombia’s medical device regulatory framework.
- Decree 3770/2004: Colombia’s IVD regulatory framework.
