INVIMA Colombia Medical Device Registration
Colombia medical device registration requires regulatory approval from INVIMA, Colombia’s medical device regulator. There are two regulatory pathways, uncontrolled and controlled, with different documentation requirements depending on device classification. Foreign manufacturers must also appoint a Colombia-based Legal Representative.
Pure Global simplifies the process with AI workflows that accelerate INVIMA submission preparation, along with local support and representation, all for a flat annual fee.
How to register a medical device in Colombia
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.
Colombia Medical Device Registration Pathways
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: Dossier + translations 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.
- 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 must appoint a Colombia-based Legal Representative to act as their liaison with INVIMA. This representative is responsible for submitting registration applications, renewals, and modifications; responding to inspections, audits, and inquiries from INVIMA; and acting on the manufacturer's behalf. The manufacturer holds the registration even they are not based in Colombia.
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. Pure Global holds CCAA licenses for medical devices and IVDs, which support your INVIMA registration, and can act as your importer in Colombia.
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Faster submissions. Predictable costs. Local support.
We provide turnkey regulatory support in Colombia, all for a flat annual fee:
Dossier preparation and submission, powered by AI assisted workflows and regulatory experts.
In country representation, with Pure Global serving as your Legal Representative.
Post market surveillance support, including vigilance reporting and authority communications.
Changing or adding importer(s) to registrations, CCAA licensing, post approval modifications, and renewals.
Frequently asked questions
INVIMA charges mandatory government fees based on product type (medical device vs. IVD) and risk classification:
For medical devices, application fees are as follows:
- Class I and Class IIa: COP 3,898,330 (approximately USD 936) per product
- Class IIb and Class III: COP 4,412,400 (approximately USD 1,059) per product
For in vitro diagnostics (IVDs):
- Class I and II IVDs: COP 2,570,590 (approximately USD 617) per product
- Class III IVDs: COP 3,427,327 (approximately USD 823) per product
A trademark application fee may apply if brand registration is required in Colombia. Trademark fees range from COP 1,288,000 to COP 1,714,500 (approximately USD 309) per application.
All fees listed are government fees only and do not include consulting services, dossier preparation, translations, or in-country regulatory representation. Additional fees may apply; government fees are subject to change without notice.
Use our Fee Calculator for up-to-date government fees in 14 markets.
Timelines vary based on device classification. For Class I and IIa devices, dossiers can be prepared and filed in about 3–4 weeks, with automatic approval from INVIMA upon submission. For Class IIb and III devices, the same preparation time applies, but INVIMA’s review and approval process typically takes 6–8 months. Once granted, registrations are valid for 10 years, except for Class III IVDs, which must be renewed every 5 years.
Pure Global offers flat-fee annual pricing for bundled medical device and IVD registration and representation in Colombia, starting at $2,000/year. The flat fee includes dossier preparation and submission, in-country representation, translation, modifications, changing or adding importer(s) to the registrations, CCAA licensing, and post-market support. The fee does not include INVIMA or other government fees, certified translations, or translations from languages other than English.
Flat fee structure for Class I/IIa devices (Class I/II IVDs):
1 device = $2,000/year
2-5 devices = additional $1,000 per device per year (e.g., 4 devices = $5,000/year)
6-10 devices = additional $500 per device per year (e.g., 8 devices = $7,500/year)
Flat fee structure for Class IIb/III devices (Class III IVDs):
1 device = $3,000/year
2-5 devices = additional $1,500 per device per year (e.g., 4 devices = $7,500/year)
6-10 devices = additional $1000 per device per year (e.g., 8 devices = $12,000/year)
Contact us for a custom quote if you have 11+ devices.
A three-year contract is required to lock in the fees quoted above. However, other contractual arrangements are available. Use our Fee Calculator for an instant estimate and more information about flat fee terms.
The registration renewal period for medical devices and IVDs in Colombia varies: Classes I and II medical devices have a 10-year renewal period, while Class III IVDs have a 5-year renewal period under INVIMA registration guidelines.
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