1. Regulatory Overview

In Colombia, medical devices are regulated by the Instituto Nacional de Vigilancia de Medicamentos y Alimentos (INVIMA), the National Institute for the Surveillance of Medicines and Foods. INVIMA ensures that medical devices entering the Colombian market meet standards of safety, efficacy, and quality.

2. Classification of Medical Devices

Medical devices in Colombia are classified based on risk level:

• Class I: Low risk

• Class IIa: Low-to-medium risk

• Class IIb: Medium-to-high risk

• Class III: High risk

Regulatory requirements increase with device risk, requiring more extensive documentation for higher-risk devices.

3. Regulatory Pathway and Requirements

The registration process varies by device class. For Class I and Class IIa devices, INVIMA offers immediate acceptanceor expedited processing, enabling faster market access. Below is an outline of the general process:

Step 1: Appoint an Authorized Representative

Foreign manufacturers must appoint an Authorized Representative (AR) or Local Responsible Agentbased in Colombia. This representative manages regulatory requirements and liaises with INVIMA.

Step 2: Prepare Technical Documentation

Technical documentation requirements vary based on classification. For all classes, basic documentation generally includes:

• Product description: Device name, classification, intended use, and labeling.

• Design and manufacturing details: Technical specifications, production processes, and materials used.

• Risk management information: Risk assessment and mitigation, especially for higher-risk classes.

• Quality Management System (QMS): ISO 13485 certification is recommended for production facilities, especially for medium- and high-risk devices.

For Class I and Class IIa devices, requirements are simplified. INVIMA often does not require extensive clinical data, focusing instead on core product details and safety standards. This simplified approach supports immediate acceptance, allowing for quicker approvals.

Step 3: Submit the Application to INVIMA

Applications are submitted via INVIMA’s Electronic Registration System (SER). For low-risk Class I and Class IIa devices, this system often allows immediate acceptance, enabling market entry within 2-4 weeksif documentation is complete.

• Class I and IIa Devices: Immediate acceptance leads to faster approvals as long as the submission meets all initial safety and regulatory standards.

• Class IIb and III Devices: Higher-risk applications undergo a comprehensive review process, which can take several months.

Step 4: INVIMA Review Process

Upon submission, INVIMA reviews each application to ensure compliance:

• Technical Evaluation: This applies mainly to Class IIb and III devices, assessing clinical evidence, risk profile, and intended use.

• Quality Review: Focuses on GMP compliance and quality systems for higher-risk classes.

For Class I and IIa devices, INVIMA’s review is usually procedural, confirming compliance with essential safety standards, and enabling faster market entry.

Step 5: Approval and Issuance of Sanitary Registration

After successful review, INVIMA issues a Sanitary Registration valid for five years, certifying compliance with Colombian regulations and allowing the device to be legally marketed.

4. Post-Registration Requirements

Once Sanitary Registration is obtained, manufacturers must comply with these post-registration requirements:

• Renewals: Apply before expiration to maintain market access; renewed registration is valid for an additional five years.

• Adverse Event Reporting: Report any device-related adverse events per Colombia’s pharmacovigilance requirements.

• Modifications: Notify INVIMA of any significant product modifications, which may require new or updated registration.

5. Timelines and Fees

Registration timelines and fees depend on classification:

• Class I and IIa Devices: Immediate acceptance approval can be achieved in 2-4 weeks, with lower fees.

• Class IIb Devices: 6-12 months, with moderate fees.

• Class III Devices: Up to 18 months, with the highest fees.

Check INVIMA’s fee schedule to confirm current rates.

6. Considerations and Best Practices

• Language Requirements: Documentation must be submitted in Spanish; certified translations may be needed for foreign documents.

• Local Testing: INVIMA may require additional local testing for specific devices.

• Professional Guidance: Engaging a local regulatory consultant familiar with INVIMA can facilitate smoother approvals, particularly for higher-risk classifications.

This guide outlines a pathways to register in Colombia, but local guidance is always recommended. Regulations are subject to change over time, and as such it is prudent to always ensure you have the most up to date information on hand. Contact LAMA today if you require assistance with your Regulatory or Commercial strategy, and let us be your guide on this exciting new journey.

Stay tuned as we continue to bring you detailed information on registration procedures throughout Latin America.

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If you’re considering expanding your brand into the LATAM market, our consultancy is here to support you every step of the way, including in the exciting realm of nanomedicine and cosmetics. Together, we can unlock the full potential of your brand in this vibrant and growing market.