Medical Devices

Medical Device Registration in Colombia – Overview

Freyr provides comprehensive regulatory consulting and lifecycle management services for medical devices in Colombia, supporting manufacturers throughout the entire regulatory process—from the definition of the initial regulatory strategy to obtaining sanitary registration and ensuring post-approval compliance.

Our services are designed to help companies navigate the Colombian regulatory framework before the National Institute for Food and Drug Surveillance (INVIMA), ensuring that medical devices comply with applicable technical, quality, and regulatory requirements prior to commercialization and throughout their presence in the market.

By combining international regulatory standards with local regulatory expertise, Freyr Colombia assists clients in managing regulatory submissions, maintaining compliance, and efficiently addressing regulatory changes, enabling market access and sustainable product lifecycle management in Colombia.

Regulatory Authority and Framework

In Colombia, medical devices are regulated by the National Institute for Food and Drug Surveillance (INVIMA), the national health authority responsible for ensuring the safety, quality, and performance of health products before and after commercialization.

The Colombian regulatory framework for medical devices is based on a risk-management approach, under which regulatory requirements vary depending on the device classification, intended use, and level of risk to patients and users. Compliance with applicable regulatory, technical, and quality requirements is mandatory for market access and continued commercialization.

Regulatory oversight extends beyond initial approval and includes post-market surveillance activities, change management, and continuous compliance with regulatory and quality obligations.

Medical Device Classification in Colombia

Medical device classification in Colombia is defined by INVIMA and is based on the intended use of the device and its potential risk to the patient or user, following principles aligned with international standards.

To determine classification, technical risk-based criteria are considered, including the duration of contact with the body, the degree of invasiveness, and whether the effect of the device is local or systemic.

In Colombia, medical devices are classified into four (04) classes:

Registration Holder, Importer, and Representation in Colombia

In Colombia, having a legal representative or a sanitary registration holder not only facilitates regulatory interaction between the health authority (INVIMA) and the medical device manufacturer—acting as a local point of contact for the administrative and regulatory management of the sanitary registration, follow-up of procedures, and response to authority requests—but is also mandatory in all cases. This designation contributes to more efficient regulatory management and ensures clear and continuous communication throughout the entire product lifecycle.

Foreign companies intending to import medical devices must appoint a certified importer holding a Storage and/or Conditioning Capacity Certificate (Certificado de Capacidad de Almacenamiento y/o Acondicionamiento – CCAA) issued by INVIMA. This certificate confirms compliance with the applicable sanitary conditions for the storage and/or conditioning of medical devices, as well as with requirements related to quality control, infrastructure, equipment, human resources, and the technical capacity of the establishment.

Medical Device Registration in Colombia

The medical device sanitary registration process in Colombia depends on the device risk classification and involves a technical and regulatory evaluation conducted by INVIMA, based on the technical, clinical, and quality information submitted in the dossier.

The technical dossier must comply with the requirements established by current Colombian regulations and align with international standards, allowing, in many cases, the reuse of documentation for regulatory processes in other regional markets.

Post-Approval Medical Device Lifecycle Management

• Post-approval change management:
  Regulatory management of modifications to the medical device sanitary registration, including changes to design, manufacturing, intended use, variants, or accessories, in accordance with INVIMA guidelines.
• Sanitary registration maintenance:
  Support in fulfilling administrative obligations associated with the sanitary registration, ensuring its validity and active status before the health authority.
• Regulatory liaison with the health authority (INVIMA):
  Acting as the regulatory interface between the registration holder, manufacturer, and INVIMA during follow-up processes, post-market surveillance, and ongoing regulatory management.
• Importation support:
  Regulatory assistance in managing requirements associated with the importation of medical devices registered in Colombia.

Freyr supports manufacturers in the comprehensive management of the regulatory lifecycle of medical devices, both prior to and after commercialization, ensuring continuous compliance and regulatory traceability.

Summary of Medical Device Registration in Colombia

Note:
Evaluation timelines may vary depending on the complexity of the dossier, the quality of the documentation submitted, and the evaluation criteria applied by INVIMA.

Colombia is considered one of the most agile Latin American countries for sanitary registration issuance. According to current legislation, the established timelines by risk classification are as follows:

• Risk Class I and IIa: within 2 business days following submission
• Risk Class IIb and III: within 90 business days following submission