What Does a Colombia INVIMA Certificate Look Like? What Information Does It Contain? - Wiselink Group-A More Controllable, Stable, and Future-Oriented Material Direction

Home > News Center > What Does a Colombia INVIMA Certificate Look Like? What Information Does It Contain?

What Does a Colombia INVIMA Certificate Look Like? What Information Does It Contain?

Time：2026-08-13 10:59:30

To legally launch products in Colombia, the INVIMA Sanitary Registration Certificate (Registro Sanitario) serves as the sole market access document. Many industry practitioners only know that the certificate enables customs clearance, yet they fail to understand the Spanish legal clauses, hidden compliance requirements, administrative appeal time limits, and mandatory UDI obligations printed on the document.

一、Certificate Header

（一）INVIMA is the exclusive issuing authority with no third-party certification bodies

INVIMA exercises full control over all human-use medical devices and in vitro diagnostic reagents in Colombia, covering the entire workflow of registration approval, post-market sampling inspection, and adverse event supervision. Its functions correspond to NMPA in China and Notified Bodies under EU regulations.

（二）Three core decrees that establish the legal validity of all certificates

Decree No. 4725 of 2005: Core regulation governing classification and registration of general medical devices (MD)
Decree No. 3770 of 2004: Independent regulatory decree for in vitro diagnostic products (IVD)
Decree No. 582 of 2017: General regulation covering market supervision, registration amendments, and renewal management

（三）Uniform header template for all risk classes

Whether it is low-risk Class I gauze or high-risk Class III implantable devices and IVD reagents, all certificates feature identical top logos, institutional names, and layouts. Risk levels cannot be distinguished from the certificate header.

二、Core Certificate Title

Por la cual se concede un Registro Sanitario：This administrative resolution grants sanitary registration qualification to the product

（一）Registro Sanitario equals official market authorization

This document is a legally binding administrative resolution rather than a simple filing receipt. Original copies must be presented for import customs clearance, local distribution, and hospital bidding verification.

（二）Unified certificate template for Class I / IIa / IIb / III products

A common misconception is that high-risk Class III products will be issued extended or specially formatted certificates, which is untrue. All certificates share identical appearances, headers, statutory clauses, and signature layouts. The only distinguishing feature is the "Clase" risk level marked in the product information section at the center of the certificate. Differences only exist in review pathways, audit intensity, official fees, and processing cycles; there is no visual distinction between finished certificates.

（三）Risk level marking on certificates

INVIMA applies two independent risk classification systems for medical devices and IVDs, which are clearly stated on each certificate and directly determine the whole registration process:

General Medical Devices (4 tiers under Decree 4725/2005)

Class I (Low Risk): Gauze, disposable examination gloves, basic surgical instruments, etc.
Class IIa (Medium-Low Risk): Disposable syringes, negative pressure suction equipment, etc.
Class IIb (Medium-High Risk): Ventilators, orthopedic consumables, non-invasive aesthetic devices, etc.
Class III (High Risk): Heart valves, pacemakers, permanent implantable devices, etc.

In Vitro Diagnostics (3 tiers under Decree 3770/2004)

Class I: Blood glucose test strips, urine analysis test strips, etc.
Class II: Blood typing reagents, biochemical analyzers, microbial culture media, etc.
Class III: Tumor marker detection kits, gene diagnostic reagents, infectious disease molecular detection reagents, etc.

三、Issuing Authority

（一）Fixed signatory position

All certificates for all product categories and risk levels are signed by the fixed position: DIRECTOR TECNICO DE DISPOSITIVOS MEDICOS Y OTRAS TECNOLOGIAS (Technical Director of Medical Devices and Other Technologies). Any certificate signed by personnel from the pharmaceutical or food department shall be deemed counterfeit directly.

（二）Three mandatory preconditions for registration approval (must be met before certificate issuance)

The certificate can only take effect if the enterprise submits the complete set of compliance documents below during application, none of which can be omitted:

ISO 13485 QMS Certificate: The most widely recognized quality system document accepted by INVIMA, covering all declared product models.
Local Colombian Registration Holder (Legal Representative): Overseas manufacturers cannot submit applications directly. The local agent acts as the exclusive liaison with INVIMA and undertakes all post-market regulatory matters.
Apostilled Free Sale Certificate (FSC): Issued by competent authorities of the country of origin, the EU, the US, Canada, Japan or Australia, apostilled under the Hague Convention and translated into Spanish; it is a fundamental document for registration.

（三）Processing cycles corresponding to classified review pathways

Pathway A (Class I / IIa Low-Risk): Fast-track automatic review, cycle of 1–2 months
Pathway B (Class IIb / III High-Risk): In-depth technical evaluation with clinical data and complete technical dossier verification, cycle of 4–6 months

四、Mandatory Annotation Clause

（一）Core content of the clause

Before registered holders launch their products on the Colombian market, they must comply with the UDI coding system specified in Resolution No. 1405 of 2022. All medical devices and IVD products shall apply for UDI-DI codes and complete system reporting to INVIMA. Non-compliance will result in penalties, cargo detention, and revocation of sanitary registration certificates in accordance with Law No. 9 of 1979.

（二）Common compliance pitfalls for exporters

UDI is a post-registration pre-market obligation, not a required document for registration submission. Enterprises are not required to provide UDI codes to obtain the certificate, yet UDI application and INVIMA system reporting must be fully completed before customs clearance or hospital sales. This mandatory requirement is printed on every certificate.
UDI requirements cover all risk levels, a key difference from EU UDI rules. Even Class I products such as cotton swabs, medical tape and examination gloves are subject to mandatory UDI filing with no exemptions; failure to complete reporting will lead to immediate cargo seizure.
Extended long-term post-market compliance requirements: The local registration holder must establish an adverse event monitoring system. Severe adverse events must be reported to INVIMA within 48 hours, and regular safety update reports shall be submitted periodically. Any modification to UDI information requires a formal registration amendment application.

五、Conclusion

For medical device enterprises expanding into South America, mastering the hidden compliance rules stated on the certificate — including UDI mandates, the 10-year validity renewal rule, the 10-day appeal deadline, and the mandatory local agent requirement — helps avoid risks such as cargo detention, registration revocation and heavy fines. If you need further information, feel free to consult Wiselink.

Previous：What Should You Know About Import Notification of Medical Devices in South Korea? What Information Needs to Be Filled In? Next：WHO Releases First Global tWLA List for Medical Devices; China’s NMPA Included!

Fill Form

Whether you need more information or wish to cooperate with us, we will guide you through every step of the regulatory process. Subscribe to our newsletter for the latest global regulatory updates.