Colombia IVD Regulation under Decreto 3770 de 2004

1. Key takeaways

In vitro diagnostic reagents (reactivos de diagnóstico in vitro) are expressly excluded from the scope of Decreto 4725 de 2005 by its Art. 1 and are governed instead by the specific decree Decreto 3770 de 2004, whose classification system consists of three tiers — Categoría I, II and III — and cannot be interchanged with the device system of I/IIa/IIb/III. Applying a device template to an IVD is the most common systematic error the GRZAN regulatory team encounters in Colombian projects.

Three differences must be kept in mind. On validity: IVD Categoría I and II certificates are valid for 10 years and Categoría III for 5 years, whereas device certificates are uniformly valid for 10 years. On the renewal window: IVD renewal must start within 6 months before expiry, while device renewal starts at least 3 months before expiry. On fees: IVD Categoría I/II pay COP 2,570,590 and Categoría III pays COP 3,427,327, under a fee schedule entirely separate from devices. In addition, the semantic standard and UDI-DI requirements of Resolución 1405 de 2022 apply to both devices and IVD reagents — this is the only obligation the two regimes share.

2. Legal basis

3. Expert insights

#### The focus of the three-tier classification differs completely from devices

The 18 rules of device Art. 7 revolve around invasiveness, duration of contact and energy supply, whereas IVD grading turns on the intended use of the test and the risk of the analyte: from Categoría I to III, risk increases with the public-health and individual consequences a wrong test result could cause. The GRZAN regulatory team’s judgment is that the device logic of body contact cannot be used to infer an IVD category, because the two regimes evaluate different objects. When preparing the dossier, companies should place analytical performance, clinical evidence, intended use and the applicable population up front, rather than copying the structure–materials–sterilization narrative of device documentation.

#### The differences in validity and renewal windows will disrupt a global registration calendar

Devices run 10 years with renewal starting at least 3 months before expiry; IVD Categoría III lasts only 5 years, with a renewal window opening within the final 6 months. For companies holding both device certificates and Categoría III IVD certificates, two calendars run in parallel — if reminders are set uniformly on the device rhythm of 3 months before expiry, a Categoría III IVD slips into a dangerously tight window or even past expiry. The GRZAN regulatory team recommends maintaining two sets of renewal reminders in the registration ledger, one per product type, and moving the renewal start point for Categoría III IVDs forward to the first day of the final 6 months.

#### The 2026 draft brings IVDs into a unified framework, but a transition period does not mean an immediate switch

The draft unified decree on the health regime for medical devices publicly released in January 2026 brings IVDs and SaMD into a unified framework and proposes an 18-month transition period; as of the verification date the draft has not been signed or published, and Decreto 3770 de 2004 remains the law in force. This means current submissions must still follow the three-tier classification, but companies should anticipate that the classification criteria may eventually be rearranged. The GRZAN judgment is that IVD companies planning a long-term presence in Colombia should not wait: they should build a solid use–analyte–risk three-part argument in the technical file now, because that argument holds under both the old and the new framework.

4. Practical recommendations

1. The GRZAN regulatory team confirms at project initiation that the product is an in vitro diagnostic reagent and immediately switches to the Decreto 3770 de 2004 pathway, without using the four-class device template.
2. Complete the classification under Categoría I / II / III, structuring the determination around the intended use of the test, the risk of the analyte and the consequences of a wrong result.
3. Restructure the technical dossier: bring analytical performance, clinical evidence, intended use and applicable population to the front, and de-emphasize the device-style structure and sterilization narrative.
4. Confirm fees under Resolución 2025067543: IVD Categoría I/II COP 2,570,590 and Categoría III COP 3,427,327.
5. Maintain two sets of renewal reminders in the registration ledger by product type: Categoría III IVDs start within 6 months before expiry, devices at least 3 months before expiry.
6. Complete the semantic report and UDI-DI coding under Resolución 1405 de 2022 — the transition period is 12 months for IVD Categoría III, 18 months for Categoría II and 24 months for Categoría I, and on March 12, 2026 INVIMA confirmed the semantic report is now fully mandatory.
7. Keep tracking the unified decree draft, and assess transition arrangements for existing IVD certificates only after the draft is signed.

5. Verification checklist

• □ The product has been confirmed as an in vitro diagnostic reagent, governed by Decreto 3770 de 2004 rather than Decreto 4725 de 2005
• □ The Categoría I / II / III classification determination has been completed with written justification retained
• □ The technical dossier has been reorganized on IVD logic (analytical performance, clinical evidence and intended use up front)
• □ Validity has been confirmed: Categoría III 5 years, Categoría I/II 10 years
• □ Renewal reminders have been set by product type (Categoría III IVD within 6 months / devices 3 months)
• □ Fee amounts have been confirmed and archived under Resolución 2025067543
• □ The semantic report and UDI-DI coding have been completed (Resolución 1405 de 2022)
• □ A tracking mechanism monitors the signature and transition arrangements of the unified decree draft

Regulatory information verified as of October 29, 2026

All outward-facing conclusions are based on the current regulatory texts published by the competent authorities and are verified item by item before delivery.

GRZAN provides end-to-end INVIMA registration and compliance support for manufacturers entering the Colombian market, covering IVD classification under Decreto 3770 de 2004, technical documentation, UDI and semantic reporting, SIRIS submissions and post-market obligations. For inquiries about INVIMA registration in Colombia, contact info@grzanglobal.com.