Semantic Reporting and UDI-DI in Colombia: Resolución 1405 de 2022 Explained

1. Key takeaways

Resolución 1405 de 2022 (published August 8, 2022) established Colombia’s estándar semántico, the semantic naming and coding standard, applicable to medical devices and in vitro diagnostics. It requires the registration holder to complete a semantic report across three categories of attributes: basic attributes (UDI-DI, GMDN code and term, registration number, issuing agency), regulatory attributes (manufacturer information, risk classification, special storage or packaging conditions), and commercial attributes (commercial description, commercial packaging unit, smallest unit of use). The UDI-DI must be issued by an accredited issuing agency, and the accredited list comprises exactly 6 organizations: GS1, HIBCC, ICCBBA, IFA, Ali Health and ZIIOT. The transition period for this obligation runs in three tiers of 12 / 18 / 24 months under Article 15 of Resolución 1405 de 2022, with the final tier ending on February 8, 2026.

GRZAN’s judgment is that the greatest cost of semantic reporting lies not in the data entry itself but in two decisions made before any filing: which issuing agency to choose, and at what granularity to place the UDI-DI. Once these two decisions are made, every subsequent product inherits them, and the cost of changing course far exceeds getting it right the first time.

2. Legal basis

3. Expert insights

1. The issuing agency must be settled first; only then does the UDI-DI have a home

A company must first become a member of one of the accredited organizations before it can obtain UDI-DI issuance. The selection criterion is not the membership fee but existing assets: if the company already uses one organization’s coding system for the EU MDR, the US FDA or other markets, reusing the same system in Colombia is the cheapest path. The UDI-DI itself has cross-market consistency, and duplicate issuance would give the same product different identifiers in different markets, creating trouble for vigilance traceability instead of solving it. GRZAN’s recommendation is to select once and reuse globally.

2. GMDN terms and commercial descriptions must be kept apart

The GMDN code and term belong to the basic attributes; the commercial description belongs to the commercial attributes. Their functions differ: the GMDN term is the regulator-facing generic naming used to identify the device category across entities, while the commercial description is the name the company uses in the market. Filling the GMDN term field with the company’s own brand name is a common entry error. GRZAN’s method is to fix the GMDN term first — selected to the most specific available term consistent with intended use and technical characteristics — and then fill the commercial description independently; neither substitutes for the other.

3. The three attribute categories are three views of one dataset, and the entry order follows from that

Basic attributes answer what this product is and who coded it; regulatory attributes answer who made it, how risky it is and how it must be stored; commercial attributes answer how it is sold in the market and in what units it is packaged and used. The order of work follows: complete the coding work first (issuance plus GMDN term selection), then align the regulatory attributes with the certificate contents (manufacturer information and risk classification must match the classification conclusions under Decreto 4725 de 2005), and fill the commercial attributes last. Reversing the order produces regulatory attributes inconsistent with the registration data, which in turn triggers verification.

4. Practical recommendations

1. Chinese manufacturers: complete the issuing agency selection before entering the Colombian market, preferring the coding system already used in other markets.
2. Regulatory affairs leads: select the most specific available GMDN term for each model and keep it separate from the commercial description.
3. Regulatory affairs leads: enter data in SIRIS in the order basic attributes, then regulatory attributes, then commercial attributes, ensuring the regulatory attributes match the information recorded under Art. 20.
4. Quality and compliance leads: incorporate the UDI-DI into product master data, with a mapping table linking models, specifications and packaging units.
5. Regulatory affairs leads: report the risk classification of IVDs by the Categoría of Decreto 3770 de 2004; do not map them onto the device Class I/IIa/IIb/III scheme.
6. Chinese manufacturers: implement UDI carriers on labels and packaging so the physical product matches the codes in the semantic report.

5. Verification checklist

• □ An issuing agency within the accredited list of Resolución 1405 de 2022 has been selected
• □ A UDI-DI has been assigned for each model, consistent with the coding used in other markets
• □ The most specific available GMDN term has been selected for each product and has not been mixed with the commercial description
• □ Data entry has been completed in the order basic, regulatory and commercial attributes
• □ The manufacturer information and risk classification in the regulatory attributes match the certificate contents
• □ The UDI carriers on labels and packaging match the codes in the semantic report, and filing evidence has been retained

Regulatory information verified as of October 29, 2026

All conclusions published here defer to the current regulatory texts as issued by the competent authority, verified item by item before delivery.

— GRZAN Regulatory Team

GRZAN provides post-market compliance support for the Colombian market, including semantic reporting under Resolución 1405 de 2022, UDI-DI strategy and issuing agency selection, GMDN term assignment, and the integration of coding data into vigilance and registration ledgers. For hands-on help with your semantic reporting obligations, contact the GRZAN regulatory team at info@grzanglobal.com.