Services Areas
Regulatory Affairs
Quality Assurance
Clinical Operations
Solutions
Consultancy
Audits & Assessments
Global Market Access
Regulatory Intelligence
Training
Interim Support
Clinical Research
Expertise
Medical Devices
Combination Devices
In Vitro Diagnostics (IVD)
Companion Diagnostics (CDx)
Global Market Access
Mergers & Acquisitions
Resource Center
Featured
Blogs
Events
About us
Careers
Contact us
search
ENG
Deutsch
Français
Contact us
  • There are no suggestions because the search field is empty.
Service Area
Colombia Medical Device Regulations

Expert support with INVIMA registration, classification, and compliance for medical devices and IVDs in Colombia. Navigate regulatory requirements with Qserve.

INVIMA Authority

Colombia Medical Device Regulations

In Colombia, the regulatory submission process for medical devices is overseen by the Instituto Nacional de Vigilancia de Medicamentos y Alimentos (INVIMA), which translates to the National Institute for Food and Drug Surveillance.  

INVIMA is responsible for regulating and overseeing the safety, efficacy, and quality of medical devices in Colombia. The primary regulation governing medical devices in Colombia is Decree 4725 of 2005, which establishes the regulatory framework for the registration, control, and surveillance of medical devices and includes definitions, classification, submission requirements, et cetera.    

Get Support Now
Services

Qserve services for Colombia

More information
Global Regulatory Strategy

A customized roadmap to align Colombian INVIMA requirements with your global regulatory and market access goals.

INVIMA Registration Support

Full support with dossier preparation, submission, and follow-up for INVIMA device registration in Colombia.

Classification Support

Determine the correct device class under Colombian regulations to ensure the proper registration pathway and documentation.

QMS Compliance Support

Guidance on aligning your Quality Management System with Colombian regulatory expectations, including ISO 13485 recognition.

Conformity Assessment Route Support

Assistance in selecting the appropriate regulatory pathway for your device type and risk class under Colombian law.

Translation of Labels and IFUs

Ensure product labels and Instructions for Use are accurately translated into Spanish and formatted according to INVIMA standards.

Registration Routes Colombia

Colombia Medical Device Registration

Medical devices in Colombia require registration with INVIMA. Adherence to international quality system standards needs to be demonstrated by submitting a QMS certificate (e.g., ISO 13485 certificate).  
 
In addition, product information and details about the product’s history need to be submitted. For class IIa, IIb and III devices, test reports need to be included in the submission dossier as well. For class IIb and III devices, clinical data is also required to be included in the submission.  

Expedited INVIMA approval for lower-risk devices 
INVIMA now offers immediate acceptance for Class I and IIa device submissions. While the full technical file still needs to be reviewed by INVIMA, the issuance of the certificate is immediate, allowing manufacturers to start importing their products right away. To maintain registration once the formal review starts, manufacturers must respond to any requests from INVIMA. This measure has been introduced to address long review times and the substantial backlog within the Ministry of Health. 

Class IIb and III devices are not eligible for this expedited process and must wait for formal review and approval, which typically takes 6 to 8 months, before they can be sold. 

Qserve Group 12
Representation for foreign manufacturers 

Risk-based classification

Colombia’s device classification system is similar to that of the European Union and other Global Harmonization Task Force (GHTF) systems. The classification of devices in Colombia follows a risk-based approach and divides devices into four different classes from lower risk (class I) to moderate risk (IIa) to higher risk (Class IIb, III).

Local representative 
Manufacturers that do not have a local entity in Colombia need to appoint a local representative to manage the registration and communicate with INVIMA on their behalf. 

Regulatory timelines and fees 
All documentation needs to be submitted in the Spanish language. Once the review has been successfully completed, approval is granted by INVIMA. The registration remains valid for a period of ten years.

Get in touch for more information about Colombia Market Access
Get Support Now
strategy
Go-to-market strategy

In terms of resemblance between the different regulatory frameworks, the way how medical devices are regulated in Colombia is a mixture of both the EU and FDA regulatory systems. A central organization overviewing and regulating the entire process resembles the American system where the focus on conformity assessment is more aligned with the EU’s system.

🖋
Medical devices and IVD registration

Our regulatory consulting specialists support market access in Colombia’s medical device market. Based on your current compliance, we can conduct a gap analysis to determine the overlap and missing elements on how to complete the technical documentation efficiently. Qserve knows the essential requirements to ensure how to achieve regulatory compliance.

server render fail/waiting for island-7f870ei1R0 (separate island render, inside)