Colombia INVIMA Medical Device Registration: Complete Guide for Foreign Manufacturers (2026)

Why Colombia Matters for Medical Device Companies

Colombia is one of the most dynamic medical device markets in Latin America and a strategic entry point for manufacturers looking to expand across the region. With a population exceeding 50 million, Colombia imports over 80% of its medical devices, creating a substantial and sustained demand for foreign-manufactured products. The Colombian medical device market is valued at approximately USD 1.5 billion with a compound annual growth rate (CAGR) of 5.7%, while the IVD market stands at approximately USD 0.29 billion with a CAGR of 4.3%.

Several factors make Colombia an attractive market for medical device manufacturers:

• Regulatory credibility — INVIMA is classified as a Level 4 regulatory authority under the PAHO/WHO classification system, the highest level of regulatory maturity. It is also a member of the International Medical Device Regulators Forum (IMDRF), signaling alignment with global best practices.
• Import-driven market — Because Colombia imports the vast majority of its medical devices, foreign manufacturers face a level playing field. There is no domestic manufacturing protectionism that favors local producers over imports.
• Regulatory modernization — INVIMA is actively revising its regulatory framework in 2026, with a new decree in progress to replace Decree 4725/2005. The updated framework will incorporate EU MDR/IVDR elements, recognize ISO 13485 as the GMP standard, and adopt IMDRF common data elements.
• Strategic location — Colombia's geographic position and trade agreements make it a natural hub for distribution into other Andean and Latin American markets.
• Efficient pathways for lower-risk devices — Colombia's "uncontrolled" (automatic approval) pathway for Class I and IIa devices allows immediate market access upon submission of a complete application, significantly reducing time-to-market for lower-risk products.

But entering Colombia requires navigating INVIMA's specific registration requirements, including its classification system, dual-pathway registration process, mandatory legal representation, UDI-DI compliance deadlines, and post-market surveillance obligations. This guide covers every aspect of the process so you can plan your market entry with confidence.

Who Is INVIMA?

INVIMA — Instituto Nacional de Vigilancia de Medicamentos y Alimentos (National Food and Drug Surveillance Institute) — is Colombia's national regulatory authority responsible for the oversight of pharmaceuticals, medical devices, food products, cosmetics, and other health-related products. Established as a decentralized agency attached to the Ministry of Health and Social Protection, INVIMA plays a central role in protecting public health through the regulation and surveillance of health products in Colombia.

For medical devices, INVIMA exercises authority over:

• Pre-market registration and evaluation of medical devices and IVDs
• Classification determination for all medical devices entering the Colombian market
• Post-market surveillance and technovigilance including adverse event reporting, signal assessment, and risk management
• Import and export control for medical devices
• Market surveillance and inspections of distributors, importers, and healthcare facilities
• Registration suspension and cancellation for non-compliant devices or manufacturers

INVIMA operates under a legal framework established primarily by two key decrees:

Legislation	Scope
Decree 4725/2005	Primary regulation governing medical device registration, classification, labeling, advertising, post-market surveillance, and commercialization in Colombia
Decree 3770/2004	Specific regulation governing in vitro diagnostic (IVD) medical devices
Resolution 1405/2022	Unique Device Identification (UDI-DI) requirements and implementation timeline

As a Level 4 PAHO/WHO-classified regulatory authority and an IMDRF member, INVIMA maintains standards that are recognized and respected internationally. This classification means that INVIMA's regulatory processes meet the highest benchmarks for transparency, consistency, and scientific rigor established by the Pan American Health Organization and the World Health Organization.

Practical tip: INVIMA's IMDRF membership and Level 4 classification mean that the agency's regulatory expectations are increasingly aligned with those of the FDA, EU MDR, and other major regulators. Manufacturers who already have FDA clearance or CE marking will find many familiar concepts in the Colombian framework, though local requirements — particularly around Spanish-language documentation and in-country representation — must be carefully addressed.

Colombia Medical Device Market Overview

Colombia's medical device market presents a compelling opportunity for foreign manufacturers, driven by several key factors:

• Market size: The medical device market is valued at approximately USD 1.5 billion, with a CAGR of 5.7%. The IVD market is approximately USD 0.29 billion with a CAGR of 4.3%.
• Import dependency: Colombia imports more than 80% of its medical devices, meaning the market is overwhelmingly supplied by foreign manufacturers. This creates significant opportunities for international companies across all device categories.
• Healthcare system: Colombia has a mixed healthcare system with both contributory (private insurance) and subsidized (public) regimes, providing broad population coverage and sustained demand for medical devices.
• Regulatory stability: Despite the upcoming regulatory modernization, INVIMA has maintained a consistent and predictable registration framework under Decree 4725/2005, giving manufacturers a clear pathway to market.

Classification System

Colombia uses a four-tier risk-based classification system for medical devices that is nearly identical to the EU MDR classification framework. The system ranges from Class I (lowest risk) to Class III (highest risk), with Classes IIa and IIb representing intermediate risk levels.

Classification Overview

Class	Risk Level	Description	Examples
Class I	Low risk	Non-invasive devices or devices that do not penetrate the body, whose failure is unlikely to cause serious harm	Bandages, tongue depressors, manual surgical instruments, hospital beds, examination gloves
Class IIa	Low-medium risk	Devices that may enter the body through natural orifices or contact the body surface for limited duration, with moderate complexity	Hypodermic needles, surgical sutures, contact lenses, blood pressure monitors, some powered surgical instruments
Class IIb	Medium-high risk	Devices that penetrate the body through surgical intervention, are implanted for extended periods, or present higher complexity	Orthopedic implants, cardiac catheters, dialysis equipment, ventilators, infusion pumps
Class III	High risk	Devices implanted in direct contact with the heart, central nervous system, or central circulatory system, or that incorporate biological materials, or that are life-supporting/life-sustaining	Cardiovascular stents, pacemakers, heart valves, defibrillators, spinal cord stimulators, devices incorporating medicinal substances

IVD medical devices are classified separately under Decree 3770/2004, with their own classification scheme that similarly follows risk-based principles.

Classification Principles

INVIMA applies the following principles when determining device classification:

• Duration of body contact — Devices intended for continuous use (more than 30 days) are generally classified higher than those intended for transient or short-term use.
• Invasiveness — Surgically invasive devices receive higher classification than non-invasive or minimally invasive devices.
• Clinical significance — Devices that are life-supporting or life-sustaining are typically classified in the highest risk class.
• Anatomical location — Devices that contact the central circulatory system or central nervous system are classified as Class III.
• Incorporation of medicinal substances or biological materials — Devices that incorporate drugs or biological materials are generally classified higher.

When a device could fall into multiple classes based on different classification rules, the highest applicable class governs.

Practical tip: Because Colombia's classification system is nearly identical to the EU MDR system, manufacturers who have already classified their devices under the EU MDR can use that classification as a reliable reference point for Colombia. However, always verify classification with INVIMA or your local legal representative, as borderline cases may be interpreted differently.

Two Registration Pathways

One of the most distinctive features of the Colombian regulatory system is its dual-pathway approach to device registration. Depending on the device classification, manufacturers follow either the "uncontrolled" (automatic approval) pathway or the "controlled" (full review) pathway.

Uncontrolled Pathway (Automatic Approval)

Applies to: Class I and Class IIa medical devices

Under the uncontrolled pathway, INVIMA grants immediate approval upon receipt of a complete application. The registration certificate is issued right away, and the manufacturer or importer can begin commercializing the device in Colombia immediately. INVIMA then conducts a post-approval review of the technical file and may issue requests for additional information, which the manufacturer must address.

Key characteristics of the uncontrolled pathway:

• Immediate approval upon submission of a complete application
• Certificate issued immediately — no waiting period before importation can begin
• Post-market review — INVIMA reviews the technical file after approval and may request additional documentation or clarification
• Manufacturer must respond to any post-approval requests from INVIMA in a timely manner
• Lower fees compared to the controlled pathway

Controlled Pathway (Full Review)

Applies to: Class IIb and Class III medical devices

Under the controlled pathway, INVIMA conducts a full technical evaluation of the application before granting approval. The agency reviews the technical dossier, clinical data, risk assessments, and all supporting documentation to determine whether the device meets the requirements for safety and performance.

Key characteristics of the controlled pathway:

• Full technical evaluation by INVIMA before approval
• Timeline: typically 6 to 8 months from submission to approval
• Clinical data required for Class IIb and Class III devices
• Test reports required for Class IIb and Class III devices
• Higher fees compared to the uncontrolled pathway
• Cannot commercialize until INVIMA issues the registration certificate

Comparison of the Two Pathways

Feature	Uncontrolled (Class I / IIa)	Controlled (Class IIb / III)
Review type	Post-approval review	Full pre-market review
Approval timeline	Immediate upon complete submission	6-8 months
Clinical data required	Not typically required	Yes
Test reports required	Not typically required (Class I); may be required (Class IIa)	Yes
Can import immediately	Yes	No — must wait for approval
Government fee	COP 3,898,330 (~USD 936)	COP 4,412,400 (~USD 1,059)
Post-approval obligations	Must respond to INVIMA requests from technical file review	Must comply with all post-market surveillance requirements

Practical tip: The uncontrolled pathway is a significant advantage for manufacturers of Class I and IIa devices. Because you receive immediate approval and can begin importing right away, the time-to-market for lower-risk devices in Colombia can be remarkably fast — often just a matter of weeks once the documentation is prepared. However, do not treat the post-approval review as a formality. INVIMA does review technical files, and failure to respond to post-approval requests can result in registration cancellation.

Registration Process Step-by-Step

The INVIMA registration process follows a defined sequence of steps. Here is a step-by-step walkthrough for foreign manufacturers:

Step 1: Determine Device Classification

Classify your device according to Colombia's four-tier risk system (Class I, IIa, IIb, or III). Because the classification system is nearly identical to the EU MDR, your existing EU classification provides a reliable starting point. For IVDs, refer to the classification criteria under Decree 3770/2004.

Step 2: Appoint a Legal Representative in Colombia

Foreign manufacturers must appoint a Legal Representative (Representante Legal) in Colombia. This is a mandatory legal requirement. The Legal Representative acts as the liaison between the manufacturer and INVIMA for all regulatory matters, including submission of applications, correspondence, and post-market obligations.

Step 3: Identify an Importer with CCAA Certification

Before registration, you must identify a Colombian importer who holds a CCAA (Certificado de Capacidad de Almacenamiento y Acondicionamiento — Certificate of Storage and Conditioning Capacity). The CCAA is a mandatory certification for any entity that imports or distributes medical devices in Colombia. The importer must be identified in the registration application.

Step 4: Prepare the Technical Dossier

Prepare a complete technical dossier in Spanish. All documentation submitted to INVIMA must be in Spanish, including technical documentation, labeling, and instructions for use. The dossier must include all required supporting documents (see the Required Documentation section below).

Step 5: Submit the Application via INVIMA Platform

Submit the registration application through INVIMA's online platform at tramites.invima.gov.co. The platform handles the submission, tracking, and communication for all registration applications.

Step 6: Pay Government Fees

Pay the applicable government fees based on the device classification. Fees are assessed per product registration.

Step 7: Wait for Approval or Begin Importing

• For Class I and IIa devices (uncontrolled pathway): Approval is granted immediately upon submission of a complete application. The registration certificate is issued, and you can begin importing right away. INVIMA will review the technical file post-approval.
• For Class IIb and III devices (controlled pathway): Wait for INVIMA to complete its full technical evaluation, which typically takes 6 to 8 months. INVIMA may request additional information during the review process.

Step 8: Receive Registration Certificate

Upon approval, INVIMA issues a registration certificate (certificado de registro sanitario) that is valid for 10 years. The certificate must be renewed three months before expiration.

Practical tip: Start the process of appointing your Legal Representative and identifying an importer with CCAA certification early, as these are prerequisites for submitting the registration application. Delays in establishing these relationships can hold up the entire registration timeline.

Required Documentation

The following documents are required for INVIMA medical device registration. All documentation must be submitted in Spanish.

Core Documentation

• Certificate of Free Sale (CFS) or Certificate to Foreign Government (CFG) — Issued by the regulatory authority of the country of origin or from a recognized market (Australia, Canada, Japan, Europe, or the United States). This is one of the most critical documents in the application and must demonstrate that the device is legally marketed in the country of issue.
• ISO 13485 certificate (or equivalent QMS certificate) — Demonstrates that the manufacturer's quality management system meets international standards. Under Colombia's upcoming regulatory framework, ISO 13485 will be formally recognized as the GMP standard for medical devices.
• Technical documentation — Comprehensive technical file including design and manufacturing information, device description, intended use, and specifications.
• Clinical data — Required for Class IIb and Class III devices. Clinical data may include clinical investigation reports, clinical evaluation reports, or literature reviews supporting the safety and performance of the device.
• Test reports — Required for Class IIa, IIb, and III devices. Includes performance testing, safety testing, biocompatibility testing, and other relevant test data.
• Risk assessment — A comprehensive risk analysis and risk management file documenting identified hazards, risk estimation, risk evaluation, and risk control measures.
• Labeling documentation in Spanish — All labeling, instructions for use (IFU), and promotional materials must be in Spanish. This includes device labels, package inserts, and user manuals.

Supporting Documentation

• Legal Representative authorization — Documentation establishing the appointment of the Legal Representative in Colombia.
• Importer CCAA certificate — Evidence that the identified importer holds a valid Certificate of Storage and Conditioning Capacity.
• Power of Attorney — If the Legal Representative is submitting on behalf of the manufacturer, appropriate power of attorney documentation.
• Manufacturer information — Company registration, facility information, and manufacturing site details.

Practical tip: The Certificate of Free Sale (CFS) is often the document that causes the most delays in the registration process. Make sure you have a valid CFS from a recognized authority before beginning the Colombian registration. INVIMA accepts CFS documents from Australia, Canada, Japan, Europe, and the United States, so manufacturers who already have regulatory clearance in any of these markets are well positioned.

UDI-DI Requirements

Colombia has implemented mandatory Unique Device Identification (UDI) requirements under Resolution 1405 of 2022. The system introduces UDI-DI (Unique Device Identification — Device Identifier) coding as a mandatory component of medical device registration and commercialization.

Key UDI-DI Requirements

• Mandatory UDI-DI coding has been introduced for all registered medical devices
• Semantic reporting process must be completed via the INVIMA web platform
• Certified issuing agencies are recognized for generating UDI codes: GS1, HIBCC, ICCBBA, IFA, Ali Health, and ZIIOT
• Non-compliance consequences are severe — devices without valid UDI-DI cannot be commercialized, and the registration is considered noncompliant

UDI-DI Compliance Deadlines

The UDI-DI requirements are being phased in based on device classification:

Device Class	Compliance Deadline
Class IIa (registered before February 2024)	February 9, 2026
Higher-risk classes	Phased deadlines per Resolution 1405/2022

Practical tip: If you have Class IIa devices that were registered before February 2024, the UDI-DI compliance deadline of February 9, 2026 is imminent or may have already passed by the time you read this. Non-compliance means your device cannot be legally commercialized in Colombia. Prioritize UDI-DI registration on the INVIMA platform immediately if you have not already done so.

Fees and Costs

INVIMA charges government fees based on device classification. The following table summarizes the current fee schedule:

Government Fees per Product Registration

Device Type	Classification	Fee (COP)	Approximate Fee (USD)
Medical Device	Class I / IIa	COP 3,898,330	~USD 936
Medical Device	Class IIb / III	COP 4,412,400	~USD 1,059
IVD	Class I / II	COP 2,570,590	~USD 617
IVD	Class III	COP 3,427,327	~USD 823

Total Cost Estimates

Government fees represent only a portion of the total cost of registration. When factoring in Legal Representative fees, document translation, technical dossier preparation, and consultant services, the typical total cost per registration ranges from approximately USD 2,000 to USD 3,000.

Cost Component	Estimated Range
Government fees (per product)	USD 617–1,059
Legal Representative fees	USD 500–1,500 (annual)
Document translation to Spanish	USD 200–800
Technical dossier preparation	USD 300–1,000
Consultant / regulatory advisor	USD 500–2,000
Total per registration	~USD 2,000–3,000

Practical tip: Colombia's registration fees are among the most competitive in Latin America, particularly for lower-risk devices. When budgeting for market entry, factor in the ongoing annual costs for Legal Representative services, as this is a recurring expense for as long as you maintain your registration in Colombia.

Timelines

Understanding the timeline for INVIMA registration is critical for market entry planning:

Registration Activity	Timeline
Document preparation (dossier, translations, CFS)	1–3 months
Legal Representative appointment and importer CCAA setup	2–6 weeks
Application submission and fee payment	1–2 weeks
Uncontrolled pathway approval (Class I / IIa)	Immediate upon complete submission
Controlled pathway review (Class IIb / III)	6–8 months
Registration certificate validity	10 years
Renewal application deadline	3 months before expiration

Key Timeline Considerations

• Fastest path: For Class I and IIa devices with a well-prepared dossier, the entire process from document preparation to market access can be completed in as little as 2 to 4 months.
• Longer path: For Class IIb and III devices, plan for a total timeline of 8 to 12 months from the start of document preparation to receipt of the registration certificate.
• Renewal planning: Registration certificates are valid for 10 years, but the renewal application must be filed at least 3 months before expiration. Mark expiration dates on your regulatory calendar well in advance.

Practical tip: For manufacturers with a broad product portfolio, consider registering Class I and IIa devices first to establish market presence and generate revenue while the Class IIb and III registrations are under review. This staggered approach can significantly improve the return on investment timeline.

Legal Representative Requirements

Every foreign manufacturer seeking to register a medical device in Colombia must appoint a Legal Representative (Representante Legal) domiciled in Colombia. This is a non-negotiable legal requirement under Decree 4725/2005.

What the Legal Representative Does

The Legal Representative serves as the manufacturer's authorized agent in Colombia for all regulatory matters. Their responsibilities include:

• Submitting registration applications to INVIMA on behalf of the foreign manufacturer
• Managing all correspondence with INVIMA, including responses to requests for additional information
• Holding the registration on behalf of the foreign manufacturer
• Coordinating post-market surveillance obligations, including adverse event reporting
• Facilitating import documentation and working with Colombian customs authorities

Selecting a Legal Representative

When selecting a Legal Representative in Colombia, consider the following:

• Regulatory expertise — The Legal Representative should have experience with INVIMA registration processes, documentation requirements, and post-market obligations.
• Communication capability — The representative must be able to communicate effectively with INVIMA in Spanish and with the manufacturer in the manufacturer's preferred language.
• Independence — The Legal Representative can be an independent regulatory consultant, a law firm, or a specialized regulatory services company. It does not need to be the importer or distributor, though it can be.
• Responsiveness — Because the Legal Representative is the point of contact for all INVIMA communications, their ability to respond promptly to requests is critical to maintaining registration compliance.

Practical tip: Choose your Legal Representative carefully. Switching representatives after registration is possible but requires a formal transfer process with INVIMA. A poor choice can result in missed deadlines, delayed responses to INVIMA requests, and even registration cancellation. Conduct due diligence and establish clear service-level agreements before making the appointment.

2026 Regulatory Updates

INVIMA is undergoing a significant regulatory modernization effort in 2026 that will reshape the medical device registration landscape in Colombia. Here is what manufacturers need to know:

New Regulatory Framework

INVIMA is developing a new decree to replace Decree 4725/2005, which has governed medical device regulation in Colombia for over two decades. The modernization process includes:

• Regulatory Impact Analysis (AIN) — A formal Regulatory Impact Analysis (Analisis de Impacto Normativo) is underway to assess the impact of the proposed changes on stakeholders.
• IMDRF alignment — INVIMA's presentation at the IMDRF in March 2026 confirmed the adoption of EU MDR/IVDR elements into the new framework, signaling deep alignment with international regulatory best practices.
• Personalized medical devices — The new framework will include provisions for personalized (custom-made) medical devices, which are not currently addressed in Decree 4725.

Key Changes Expected in the New Framework

Area	Expected Change
GMP recognition	ISO 13485 will be formally recognized as the GMP standard for medical devices
Personalized devices	New provisions for custom-made and patient-specific devices
Safety and performance	Incorporation of essential principles of safety and performance, aligned with IMDRF
Common data elements	Adoption of IMDRF common data elements for registration submissions
EU MDR/IVDR alignment	Adoption of elements from the EU MDR and IVDR regulatory frameworks
Expedited review	Development of an expedited review process for certain device categories

UDI-DI Compliance Deadline

The UDI-DI compliance deadline for Class IIa devices registered before February 2024 is February 9, 2026. Manufacturers who have not yet completed UDI-DI registration for these devices face the risk of their registrations being considered noncompliant, which means the devices cannot be legally commercialized.

Practical tip: The regulatory changes coming in 2026 represent both a challenge and an opportunity. Manufacturers who are already registered in Colombia should monitor the new decree closely, as it may introduce new compliance requirements. Manufacturers who are planning market entry should consider engaging with a local regulatory advisor who can track the regulatory changes and advise on how they may affect registration strategy.

Post-Market Surveillance

INVIMA maintains a comprehensive post-market surveillance system for medical devices, known as technovigilance (tecnovigilancia). Once a device is registered and commercialized in Colombia, manufacturers and their Legal Representatives must comply with ongoing post-market obligations.

Technovigilance Requirements

INVIMA's technovigilance system encompasses the following:

• Adverse event reporting — Manufacturers (through their Legal Representatives) must report adverse events associated with their devices to INVIMA. This includes serious adverse events, deaths, and near-incidents.
• Signal assessment and risk management — INVIMA conducts signal assessment to identify potential safety issues with marketed devices. Manufacturers must cooperate with INVIMA investigations and implement risk management measures as directed.
• Sentinel Hospital Network — INVIMA operates a Sentinel Hospital Network (Red de Hospitales Centinela) that monitors device performance and adverse events in clinical settings across Colombia.
• Quality problem tracking — INVIMA tracks quality problems, complaints, and non-conformities reported for registered devices.
• Field safety corrective actions — Manufacturers must report and implement recalls, field safety notices, and other corrective actions in coordination with INVIMA.

Consequences of Non-Compliance

INVIMA has the authority to take enforcement actions against manufacturers and registrations that fail to comply with post-market surveillance requirements. These actions include:

• Registration suspension — Temporary suspension of the registration certificate, prohibiting commercialization of the device
• Registration cancellation — Permanent cancellation of the registration, requiring a new application to re-enter the market
• Import restrictions — Suspension or revocation of import permits
• Fines and penalties — Monetary penalties for regulatory non-compliance. Fines can reach up to 10,000 monthly minimum wages (approximately USD 3.2 million in 2026), along with product seizure and potential temporary or permanent business closure

Practical tip: Post-market surveillance is not optional in Colombia. Establish a clear process with your Legal Representative for receiving, documenting, and reporting adverse events. Ensure that complaint handling procedures cover the Colombian reporting requirements in addition to your obligations in other markets. A well-functioning technovigilance process protects both patients and your registration.

Frequently Asked Questions

How long does INVIMA registration take?

For Class I and IIa devices (uncontrolled pathway), approval is immediate upon submission of a complete application. You receive the registration certificate and can begin importing right away. For Class IIb and III devices (controlled pathway), INVIMA conducts a full technical review that typically takes 6 to 8 months. When factoring in document preparation, the total timeline from start to registration is typically 2 to 4 months for Class I/IIa devices and 8 to 12 months for Class IIb/III devices.

Is a Legal Representative mandatory for foreign manufacturers?

Yes. Every foreign manufacturer must appoint a Legal Representative (Representante Legal) domiciled in Colombia. This is a legal requirement under Decree 4725/2005 and cannot be waived. The Legal Representative acts as the manufacturer's authorized agent for all regulatory matters before INVIMA, including application submission, correspondence, and post-market obligations.

What is the CCAA and why is it required?

CCAA stands for Certificado de Capacidad de Almacenamiento y Acondicionamiento (Certificate of Storage and Conditioning Capacity). It is a mandatory certification for any entity that imports or distributes medical devices in Colombia. The CCAA demonstrates that the importer has adequate storage facilities and handling capabilities to maintain the safety and quality of medical devices. You must identify an importer with a valid CCAA before submitting your registration application.

Can I use my FDA clearance or CE mark to expedite registration in Colombia?

Colombia does not have a formal equivalency or reliance pathway like some other Latin American countries. However, a Certificate of Free Sale (CFS) or Certificate to Foreign Government (CFG) from a recognized market (US, EU, Canada, Japan, or Australia) is a required document in the registration application. Having FDA clearance or a CE mark provides supporting evidence for the technical file and facilitates the registration process, but it does not substitute for the INVIMA registration itself.

How much does INVIMA registration cost?

Government fees range from COP 2,570,590 (~USD 617) for IVD Class I/II devices to COP 4,412,400 (~USD 1,059) for Class IIb/III medical devices, per product registration. When including Legal Representative fees, translation costs, dossier preparation, and consultant services, the total cost typically ranges from USD 2,000 to USD 3,000 per registration.

How long is the INVIMA registration valid?

INVIMA registration certificates are valid for 10 years. Renewal applications must be submitted at least 3 months before the expiration date. The renewal process requires updated documentation demonstrating continued compliance with regulatory requirements.

What are the UDI-DI requirements in Colombia?

Under Resolution 1405 of 2022, Colombia has implemented mandatory UDI-DI (Unique Device Identification — Device Identifier) coding for medical devices. Manufacturers must report UDI-DI codes through the INVIMA web platform using a semantic reporting process. UDI codes must be obtained from certified issuing agencies: GS1, HIBCC, ICCBBA, IFA, Ali Health, or ZIIOT. The compliance deadline for Class IIa devices registered before February 2024 was February 9, 2026. Non-compliance means the device cannot be commercialized and the registration is considered noncompliant.

What language must the documentation be in?

All documentation submitted to INVIMA must be in Spanish. This includes the technical dossier, labeling, instructions for use, promotional materials, and all correspondence. Foreign-language documents must be translated by a certified translator before submission.

Do I need clinical data for registration?

Clinical data is required for Class IIb and Class III devices (controlled pathway). For Class I and IIa devices (uncontrolled pathway), clinical data is not typically required as part of the initial application, though INVIMA may request it during the post-approval technical file review.

What happens if INVIMA requests additional information during the review?

For controlled pathway devices (Class IIb/III), INVIMA may issue requests for additional information during the technical review. Your Legal Representative must respond to these requests within the timeframe specified by INVIMA. Failure to respond in a timely manner can result in the application being rejected. For uncontrolled pathway devices (Class I/IIa), INVIMA conducts the technical file review post-approval, and the manufacturer (through the Legal Representative) must respond to any requests to maintain the registration.

Is ISO 13485 certification required?

ISO 13485 certification (or an equivalent QMS certificate) is a required document in the INVIMA registration application. Under the upcoming regulatory framework, ISO 13485 will be formally recognized as the GMP standard for medical devices in Colombia. Manufacturers who already hold ISO 13485 certification from an accredited certification body meet this requirement.

What regulatory changes should I expect in 2026?

INVIMA is developing a new decree to replace Decree 4725/2005. Key changes expected include formal recognition of ISO 13485 as the GMP standard, adoption of EU MDR/IVDR elements, inclusion of personalized medical devices, incorporation of essential principles of safety and performance (aligned with IMDRF), adoption of IMDRF common data elements for registration submissions, and the development of an expedited review process. INVIMA presented these changes at the IMDRF in March 2026. Manufacturers should monitor the progress of the new decree and prepare for updated compliance requirements.

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Colombia's INVIMA registration system offers a well-structured and increasingly modernized pathway for foreign medical device manufacturers. The combination of immediate approval for lower-risk devices, reasonable fees, a 10-year registration validity, and alignment with international standards makes Colombia one of the more accessible and attractive markets in Latin America. With the regulatory modernization underway in 2026, the framework will only become more aligned with global best practices — reinforcing Colombia's position as a Level 4 PAHO/WHO-classified authority and a market worth serious consideration in any LATAM expansion strategy.