INVIMA Colombia Medical Device Registration

Medical device and IVD registration in Colombia is governed by INVIMA and follows a risk-based framework under Decree 4725/2005 (medical devices) and Decree 3770/2004 (IVDs). Foreign manufacturers must appoint both a Legal Representative and a licensed importer with an INVIMA-issued CCAA, and all documentation must be submitted in Spanish.

INVIMA Colombia medical device classification:

Devices are classified into Class I, IIa, IIb, and III; IVDs are classified into Class I, II, and III. This classification determines whether they qualify for automatic approval or require full technical review.

Automatic approval (Class I and IIa devices; Class I–II IVDs):

• Process: Immediate authorization once a complete application is submitted; INVIMA does not review the technical file before granting approval. ‍
• Requirements: A complete dossier in Spanish, ISO 13485 or equivalent QMS evidence, labeling documentation, CFS/CFG from an accepted reference market, UDI-DI codes, semantic reporting, and a Legal Representative and licensed importer.
• ‍Timeline: Approval is typically granted within days. ‍
• Renewal: Valid for 10 years; renewals for low-risk devices are usually approved quickly.

Controlled review (Class IIb and III devices; Class III IVDs):

• Process: INVIMA conducts a detailed evaluation of the technical documentation, performance and test data, clinical evidence (for Class III), labeling, and QMS evidence before approval. ‍
• Requirements: Full dossier including risk assessments, design and manufacturing information, test reports, clinical data (as applicable), UDI-DI compliance, and all legal and commercial documents are required for this INVIMA registration pathway. ‍
• Timeline: Review times vary based on device complexity and completeness of the submission; higher-risk devices require formal evaluation. ‍
• Renewal: Medical devices are valid for 10 years; Class III IVDs for 5 years. Renewal applications must be submitted 3–6 months before expiration.

Other INVIMA registration requirements:

• Legal Representative: Mandatory for all foreign manufacturers seeking INVIMA Colombia registration; responsible for registration, vigilance reporting, semantic reporting, labeling oversight, and advertising compliance.
• ‍Importer requirements: Importers must hold a valid CCAA from INVIMA and comply with strict storage, customs, documentation, and vigilance obligations. ‍
• Documentation: All submissions must be in Spanish, and imported devices must include a supplemental Spanish label. ‍
• UDI-DI and semantic reporting: Resolution 1405/2022 requires UDI-DI codes from accredited agencies and a semantic report detailing regulatory and commercial attributes. ‍
• Post-market obligations: Manufacturers and importers must submit quarterly technovigilance reports and report adverse events within strict timelines.

What are the regulatory pathways for medical devices and IVDs in Colombia?

Colombia offers two pathways: uncontrolled (automatic approval) for lower-risk devices and controlled (full review) for higher-risk products. IVDs follow the same pattern.

Uncontrolled Pathway (Automatic Registration): Class I and IIa devices follow the uncontrolled route. INVIMA grants immediate approval once documentation is filed, typically within days.

Controlled Pathway (Full Review): Class IIb and III devices follow the controlled pathway and require INVIMA to evaluate the technical dossier, clinical evidence, and labeling before approval. These reviews require additional time but vary depending on device risk, data volume, and any information requests.

What documentation is required to register a medical device or IVD with INVIMA?

Manufacturers must provide technical, safety, labeling, and quality documentation in Spanish, along with a Certificate of Free Sale and proof of QMS compliance, device descriptions, its intended use, components, materials, history, and performance characteristics.

A complete dossier generally includes:

• Legal Representative authorization

• Device description and history

• Risk assessments and essential performance data

• Design and manufacturing information

• ISO 13485 or equivalent QMS evidence

• Clinical data (for Class III devices)

• Test reports (for Class IIa, IIb, III devices)

• Labeling information

• Certificate of Free Sale (CFS/CFG) from the country of origin or recognized markets (EU, US, CA, JP, AU)

What is a Legal Representative in Colombia and why do you need one?

Foreign manufacturers cannot register devices directly. They must appoint a Colombia-based Legal Representative to hold the registration and act as their liaison with INVIMA. This representative is responsible for submitting documentation, maintaining compliance, completing semantic and UDI-DI reporting, submitting vigilance reports, and serving as the local contact for authorities.

Does Colombia require an authorized importer?

Foreign manufacturers must appoint a licensed importer with an INVIMA-issued Certificate of Storage and Conditioning Capacity (CCAA). The importer is responsible for import registrations, customs filings, storage compliance, and post-market vigilance reporting.