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.
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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. Medical Device Classification in Colombia
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.