Semantic Standard and Coding of Medical Devices for Colombia

Following the issuance of Resolution 1405 of 2022 (published on August 8, 2022) and the completion of the transitional implementation period, the semantic standard report is now a mandatory requirement for the commercialization of medical devices and in vitro diagnostic reagents (IVDs) in Colombia as of February 8, 2026. 

 

This article was updated in March 2026 to reflect the official communication issued by INVIMA on March 12, 2026, confirming the end of the transitory period and the full enforceability of the semantic reporting obligation. 

 

This article explains the scope of the semantic report, its regulatory background, the stakeholders involved, and the current compliance requirements applicable in Colombia. 

  

Semantic Report 

  

On February 8, 2024, INVIMA enabled a web platform to facilitate reporting under the semantic standard for medical devices and IVDs, as mandated by the Resolution 1405 of 2022. This resolution outlines the attributes and coding standards for these products to be commercialized in the Colombian market, defining adoption and implementation procedures along with associated deadlines. 

 

As of February 8, 2026, the semantic report is no longer transitional and has become a prerequisite for initiating or continuing commercialization of medical devices and IVDs in Colombia. 

 

The semantic report is the tool for identifying, designating, and classifying medical devices and IVDs. This will be enhancing traceability and information exchange among stakeholders involved in product commercialization; it also contributes to improving regulatory compliance and market surveillance. For this standardization Colombia has adopted the Unique Device Identifier (UDI) codes. 

 

 

Transitory Period (completed) 

  

To allow the industry to adapt, Resolution 1405 of 2022 established a phased transitory period applicable to sanitary registrations and modifications granted on or before February 7, 2024. 

 

The transitional timelines were as follows: 

  

• Class III medical devices and Category III IVDs: 12 months transition period (ended February 8, 2025). 

• Class IIb medical devices and Category II IVDs: 18 months transition period (ended August 8, 2025). 

• Class IIa and I medical devices and Category I IVDs: 24 months transition period (ended February 8, 2026). 

  

With the transitional regime concluded, semantic reporting is now a mandatory requirement for the commercialization of all applicable medical devices and IVDs in Colombia. 

  

Key stakeholders 

 

The semantic reporting process involves active participation from various stakeholders, including: 

  

• The Holder of the sanitary registration, who assumes responsibility to execute the semantic report process. 

• Manufacturer and/or brand owner, tasked with procuring UDI-DI codes from certified agencies. 

• INVIMA, authority that verifies the information submitted via the designated web platform and granting approval for commercialization. 

  

Attributes for the Semantic Report 

  

The report encompasses three attribute categories: basic, regulatory, and commercial, which cover essential information related to the product identification, regulatory compliance, and commercialization. 

  

Process 

The semantic report process involves four key steps: 

  

1. Obtain the INVIMA approval for the sanitary registration. 
2. Obtain UDI-DI codes from the manufacturer, certified by relevant agencies. 
3. Submit the semantic report through INVIMA’s website (exclusively by the sanitary registration holder) 
4. Pay the applicable INVIMA fee to receive the electronic document that guarantees the completion of the report. 

 

Frequently Asked Questions (FAQ) 

 

1. Is the semantic standard report mandatory for medical devices and IVDs in Colombia?

   Yes. The semantic standard report is mandatory as of February 8, 2026. This obligation derives from Resolution 1405 of 2022, published on August 8, 2022, and was confirmed by INVIMA’s official communication following the end of the transitory period.

2. Which products are required to comply with the semantic reporting obligation?

   The requirement applies to all medical devices for human use and in vitro diagnostic reagents (IVDs) commercialized in Colombia that fall within the scope of Resolution 1405 of 2022, including:-  Class I, IIa, IIb, and III medical devices
   – Category I, II, and III IVDs

   As of February 8, 2026, no product within these categories may be commercialized without completing the semantic report.

3. Who is responsible for submitting the semantic report to INVIMA?

   The holder of the sanitary registration is legally responsible for submitting the semantic report through INVIMA’s designated web platform. However, the process requires coordination with the manufacturer and/or brand owner, who must provide the corresponding UDI‑DI codes issued by accredited agencies.

4. What happens if a company fails to submit the semantic report? 

Failure to comply may result in sanitary safety measures and regulatory actions, including: 

• • Suspension of commercialization in Colombia 

• • Administrative sanctions in accordance with applicable health regulation 

 INVIMA has indicated that compliance with the semantic standard is now a condition for lawful commercialization. 

 

Conclusion 

  

With the full implementation of Resolution 1405 of 2022 and the end of the transitory period on February 8, 2026, semantic standard reporting is now an enforceable and mandatory requirement for medical devices and IVDs in Colombia. 

 

For further guidance on navigating the semantic reporting process and ongoing regulatory compliance, please contact us at [email protected].