INVIMA Medical Device Registration & Representative Colombia
Enter Latin America's third-largest medical device market a USD 1.5B+ sector where over 80% of devices are imported. NexorTest delivers end-to-end INVIMA registration Class I/IIa/IIb/III sanitary registration, the automatic (Uncontrolled) fast track for low risk devices, independent Colombia Legal Representative services, CCAA importer coordination, and UDI DI / Resolution 1405 compliance all under one expert roof.
Four EU Aligned Device Classes Under Colombian Health Law
INVIMA classifies all medical devices and IVDs using a risk based classification framework broadly aligned with International GHTF and European regulation principles.
Class I Devices
Low risk devices such as bandages, non-invasive instruments, and non-sterile gloves. Eligible for the Uncontrolled automatic registration pathway with the lightest documentation burden.
- Automatic Approval
- 15 Working Days
- 10 Year Validity
Class IIa Devices
Moderate risk devices including certain surgical instruments, diagnostic devices, and reusable syringes. Also eligible for automatic registration import can begin on submission.
- USD 936 Fee
- Uncontrolled Pathway
- Test Reports
Class IIb Devices
Higher risk devices including implantables, specific catheters, and high risk diagnostics. Follow the Controlled pathway full INVIMA technical review before market entry.
- USD 1,059 Fee
- Controlled Pathway
- Clinical Data
Class III Devices
The highest risk, life supporting or life sustaining devices such as implantable defibrillators, heart valves, and orthopaedic implants. Most rigorous technical and clinical review.
- USD 1,059 Fee
- Full Dossier
- Clinical Evidence
Two Pathways to Your Registro Sanitario
INVIMA offers two routes to market authorization. Choosing the right one driven by your device class determines whether you reach the Colombian market in weeks or in months.
Uncontrolled (Automatic) Pathway
For Class I and Class IIa medical devices and Class I & II IVDs. INVIMA issues the Registro Sanitario immediately upon a complete submission, so you can import and sell right away while the technical file is reviewed afterward. Introduced to clear INVIMA’s backlog one of the most efficient low risk routes in Latin America.
Controlled (Full Review) Pathway
For Class IIb and Class III medical devices and Class III IVDs. INVIMA conducts a full legal and technical evaluation of the dossier, clinical evidence, and labeling before issuing an administrative act of approval. Devices with unclear classification may require prior evaluation by INVIMA’s Medical Device Reviewing Commission. A deficiency free dossier is the key to staying on the shorter end of the range.
Comprehensive Colombia Regulatory Services
From classification and Legal Representative services through pharmacovigilance, NexorTest manages every aspect of your INVIMA regulatory journey.
INVIMA Sanitary Registration
Complete Registro Sanitario for Class I, IIa, IIb, and III medical devices and IVDs. We manage classification, pathway selection, dossier preparation, INVIMA platform submission, fee payment, and query resolution end to end.
Automatic Pathway Fast-Track
Uncontrolled pathway submissions for Class I and IIa devices that let you import and sell from day one. We assemble a complete, audit ready dossier so your automatic approval is never put at risk by a later information request.
Controlled Pathway Management
For Class IIb and III devices, we prepare the full technical dossier, manage INVIMA's legal and technical review, and respond to every information request within the 30 business day window to keep your review on track.
Colombia Legal Representative
Independent in-country Legal Representative services. NexorTest can act as independent legal representative, helping maintain regulatory continuity across commercial partners.
CCAA Importer Coordination
Foreign manufacturers must designate a licensed importer holding a valid CCAA (Certificate of Storage and Conditioning Capacity). We help you identify and coordinate a compliant importer or structure the arrangement so your registration stays independent of any single commercial partner.
UDI DI & Resolution 1405
Unique Device Identifier (UDI DI) assignment from certified agencies (GS1, HIBCC, ICCBBA, IFA), plus the mandatory semantic report covering basic, regulatory, and commercial attributes via INVIMA's platform the compliance step most consultants under deliver on.
ISO 13485 & QMS Evidence
Quality system support for INVIMA. We confirm whether your ISO 13485, ISO 9001, or FDA Establishment Registration satisfies the QMS requirement for your class, run gap analysis, and prepare you for any INVIMA facility inspection.
Spanish Labeling & Apostille
Spanish language labeling and Instructions for Use to Colombian standards importer/representative details, marketing permit, and registration number. We manage certified translations and apostille of US/foreign documents that prevent the most common cause of rejection.
IVD Registration Colombia
In Vitro Diagnostic registration under the Class I/II/III framework of Decree 3770/2004, including analytical and clinical performance evidence, reagent documentation, and automatic registration for eligible Class I and II IVDs.
SaMD & Digital Health
Software as a Medical Device strategy for Colombia software lifecycle and validation documentation, cybersecurity risk assessment, AI/ML evidence, and registration aligned with INVIMA's EU aligned and IMDRF converging framework.
Pharmacovigilance & Renewals
Periodic post-market reporting as required by INVIMA, adverse event reporting within applicable INVIMA reporting timelines, field safety corrective actions, change notifications, and 10 year renewals we keep your Registro Sanitario active and compliant throughout its lifecycle.
Andean & LATAM Expansion
Coordinate Colombia INVIMA alongside Brazil ANVISA, Mexico COFEPRIS, Peru DIGEMID, and Argentina ANMAT from a single integrated program ideal for a regional Andean and Latin American launch strategy.
Colombia's Trusted INVIMA Specialist
We combine an on-the-ground Bogotá regulatory team with global reference market expertise to deliver faster, more predictable INVIMA approvals.
Bilingual Bogotá Regulatory Team
Spanish native regulatory professionals who know INVIMA's online platform, reviewers, and the Medical Device Reviewing Commission first hand not an offshore desk learning the system from a distance.
Automatic Pathway Speed Specialists
We turn your FDA, CE, or Health Canada approval into a complete Class I/IIa filing that clears the Uncontrolled pathway so you import from day one while protecting against the later information requests that catch unprepared filers.
Independent Legal Rep You Keep Control
We hold your registration as a neutral Legal Representative, separate from your importer, so you can switch or add importers and distributors anytime without your authorization being held hostage by a single commercial partner.
UDI DI & Semantic Reporting Done Right
Resolution 1405/2022 compliance is where many registrations stall. We manage UDI DI assignment and the semantic report end to end, keeping new and existing registrations fully compliant after the February 2026 deadlines.
Transparent Fixed Fee Packages
We offer fixed-fee services covering strategy, Legal Representative, dossier preparation, submission, and post-market support. Our defined scope, milestones, and pricing provide clarity throughout your project.
Six Steps to Your Registro Sanitario
A proven, structured approach that minimizes INVIMA information requests and accelerates your path to the Colombian medical device market.
Classification & Pathway Strategy
We confirm your INVIMA risk class (I, IIa, IIb, or III) under EU aligned rules and determine whether your device follows the Uncontrolled automatic pathway or the Controlled full review pathway setting realistic timelines from day one.
Appoint Legal Rep & CCAA Importer
NexorTest is appointed as your independent Legal Representative. We help designate a CCAA licensed importer, set up the INVIMA platform account, and prepare all legal and power of attorney documentation.
Dossier Preparation in Spanish
We compile and translate the dossier: device description, risk analysis (ISO 14971), ISO 13485 / QMS evidence, clinical and test data, Certificate of Free Sale, apostilled documents, and compliant Spanish labeling.
UDI-DI & Semantic Report
We obtain UDI DI codes from a certified issuing agency and prepare the Resolution 1405/2022 semantic report the basic, regulatory, and commercial attributes INVIMA requires for traceability.
INVIMA Submission & Query Management
We submit through INVIMA’s online platform, pay government fees, and manage every information request and deficiency response within the 30 business day windows to keep the review moving toward approval.
Registro Sanitario & Post-Market
You receive your Registro Sanitario. We set up pharmacovigilance and Periodic Reporting and manage change notifications and renewals valid for 10 years.
INVIMA Expertise Across Every Device Category
From implantables to digital health, our regulatory specialists cover the full breadth of medical technology entering the Colombian market.
- 🩺 Implantable Devices
- 🧬 In Vitro Diagnostics
- 💻 SaMD & Digital Health
- 🩻 Imaging & Radiology
- 🦴 Orthopaedics
- 💉 Infusion & Drug Delivery
- 🩸 Surgical Instruments
- 👁 Ophthalmics
- 🦷 Dental Devices
- 🏥 Electro-Medical Equipment
- 🧪 Laboratory Equipment
- 📱 Wearables & Remote Monitoring
INVIMA Registration FAQ's
What is INVIMA medical device registration in Colombia?
INVIMA medical device registration (Registro Sanitario) is the mandatory market authorization issued by the Instituto Nacional de Vigilancia de Medicamentos y Alimentos, Colombia’s medical device and IVD regulator under the Ministry of Health and Social Protection. Under Decree 4725/2005 (devices) and Decree 3770/2004 (IVDs), every device imported into or sold in Colombia must hold a valid Registro Sanitario before commercialization. The process involves classification (Class I, IIa, IIb, or III), appointment of a Colombia Legal Representative and a CCAA licensed importer for foreign manufacturers, dossier preparation in Spanish, and submission via the Uncontrolled (automatic) pathway for Class I/IIa or the Controlled (full review) pathway for Class IIb/III. Registrations are valid for 10 years.
What are the INVIMA device classification classes?
INVIMA uses a four tier risk based system mirroring the EU MDR. Class I covers low risk devices (bandages, non-invasive instruments, non-sterile gloves). Class IIa covers moderate risk devices (certain surgical instruments, diagnostic devices, reusable syringes). Class IIb covers higher risk devices (implantables, specific catheters, high risk diagnostics). Class III covers the highest risk, life supporting or life sustaining devices. IVDs are classified separately into Class I, II, and III under Decree 3770/2004. Classification is rule based on intended use, body contact, and invasiveness, and determines the pathway, documentation, fees, and timeline.
What is a Colombia Legal Representative?
A Colombia Legal Representative (Representante Legal) is a locally established entity that acts as the official in-country liaison and holder of a foreign manufacturer’s INVIMA Registro Sanitario. It is a legal prerequisite for any manufacturer without a local presence. The Legal Representative submits applications, manages renewals, change notifications, and variations, serves as the official contact with INVIMA, and handles pharmacovigilance reporting. Foreign manufacturers must also designate a licensed importer holding a valid CCAA. NexorTest provides independent Legal Representative services, holding your registration neutrally so you retain full freedom to appoint or replace importers and distributors without losing control of your authorizations.
What is the automatic (Uncontrolled) pathway?
The Uncontrolled pathway (automatic registration) applies to lower risk Class I and Class IIa medical devices and Class I and II IVDs. INVIMA issues the Registro Sanitario immediately upon a complete dossier submission, so manufacturers can begin importing and selling right away while the technical file is reviewed afterward. This was introduced to address INVIMA’s review backlog and makes Colombia one of the most efficient LATAM markets for low to moderate risk devices, with certificate issuance typically within about 15 working days. Class IIb and III devices are not eligible and must instead follow the Controlled pathway, with full review before market entry, generally 6 to 8 months.
How long does INVIMA registration take?
Timelines depend on class and pathway. Class I and IIa devices on the Uncontrolled pathway can import almost immediately, with certificate issuance typically within about 15 working days. Class IIb and III devices on the Controlled pathway require full INVIMA review, generally 6 to 8 months despite an official 15 working day target, due to backlogs. Class III IVDs have an official 90 working day timeline that in practice can extend to 6-8 months. Dossier preparation usually adds 3-4 weeks. Documentation completeness is the biggest driver; NexorTest’s pre-submission review minimizes information requests that pause the clock.
What documents are required for INVIMA registration?
Required documents include: a technical dossier with device description, intended use, and design/manufacturing information; a Certificate of Free Sale (CFS) or Certificate to Foreign Government from the country of origin or an accepted reference market (US, EU, Canada, Japan, Australia); ISO 13485 or equivalent QMS evidence (ISO 9001 or an FDA Establishment Registration can satisfy this for Class I/IIa); risk analysis (ISO 14971); test reports for Class IIa/IIb/III and clinical data for Class IIb/III; UDI DI codes and a Resolution 1405/2022 semantic report; Spanish-language labeling and IFU; the Legal Representative authorization; and a CCAA licensed importer designation. NexorTest prepares and quality checks the full dossier in Spanish, with apostille and certified translation management, before submission.
What is UDI-DI and Resolution 1405/2022?
Resolution 1405 of 2022 introduced mandatory Unique Device Identifier Device Identifier (UDI DI) codes and a semantic reporting process for medical devices and IVDs in Colombia. Registration holders must obtain UDI DI codes from a certified issuing agency (GS1, HIBCC, ICCBBA, IFA, Ali Health, ZIIOT), secure INVIMA approval, submit a semantic report covering the device’s basic, regulatory, and commercial attributes via INVIMA’s web platform, and pay a fee. The requirement is in force, with the final deadline for Class IIa, Class I, and Category I IVD devices having passed on 9 February 2026. Non-compliance can interrupt commercialization. NexorTest manages UDI DI assignment, semantic reporting, and platform submission end to end.
What is the cost of INVIMA registration?
Costs include government fees, professional fees, and Legal Representative fees. Indicative INVIMA government application fees are roughly COP 3,898,330 (about USD 936) for Class I and IIa, and COP 4,412,400 (about USD 1,059) for Class IIb and III, per product. The all-in cost through a consultant or Legal Representative typically runs USD 2,000-3,000 per registration including government fees and translations making Colombia one of the most cost effective LATAM markets. Renewal fees are usually no more than 50% of the original cost, and annual recurring representation and vigilance costs are commonly budgeted around USD 5,000. NexorTest offers transparent fixed fee packages. Contact us for a free cost assessment.
Ready to Enter the Colombian Medical Device Market?
Get a free INVIMA regulatory assessment from specialists in Colombian market access. Our experts will map your accelerated registration route including the automatic Uncontrolled pathway to a Registro Sanitario.