{"id":2963,"date":"2024-04-02T23:02:36","date_gmt":"2024-04-02T23:02:36","guid":{"rendered":"https:\/\/veraqueconsulting.com\/co\/?p=2963"},"modified":"2026-03-24T17:04:29","modified_gmt":"2026-03-24T17:04:29","slug":"semantic-standard-and-coding-of-medical-devices-for-colombia","status":"publish","type":"post","link":"https:\/\/veraqueconsulting.com\/co\/semantic-standard-and-coding-of-medical-devices-for-colombia\/","title":{"rendered":"Semantic Standard and Coding of Medical Devices for Colombia"},"content":{"rendered":"

Following the issuance of\u00a0Resolution 1405 of 2022 (published on August 8, 2022)\u00a0and the completion of the transitional implementation period, the\u00a0semantic 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.<\/span>\u00a0<\/span><\/p>\n

\u00a0<\/span><\/p>\n

This article was\u00a0updated in March 2026\u00a0to reflect\u00a0<\/span>the official communication issued by\u00a0INVIMA on March 12, 2026<\/span><\/a>, confirming the end of the transitory period and the full enforceability of the semantic reporting obligation.<\/span>\u00a0<\/span><\/p>\n

\u00a0<\/span><\/p>\n

This article explains the scope of the semantic report, its regulatory background, the stakeholders involved, and the current compliance requirements applicable in Colombia.<\/span>\u00a0<\/span><\/p>\n

\u00a0<\/span>\u00a0<\/span><\/p>\n

Semantic Report<\/span><\/b>\u00a0<\/span><\/h3>\n

\u00a0<\/span>\u00a0<\/span><\/p>\n

On February\u00a08, 2024, INVIMA enabled a web platform to\u00a0facilitate\u00a0reporting under the semantic standard for medical devices and IVDs, as mandated by the\u00a0<\/span>Resolution<\/span><\/b>\u00a01405 of 2022<\/span><\/b><\/a>.<\/span>\u00a0This 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.<\/span>\u00a0<\/span><\/p>\n

\u00a0<\/span><\/p>\n

As of\u00a0February 8, 2026, the semantic report is no longer transitional and has become a\u00a0prerequisite for\u00a0initiating\u00a0or continuing commercialization\u00a0o<\/span>f medical devices and IVDs in Colombia.<\/span>\u00a0<\/span><\/p>\n

\u00a0<\/span><\/p>\n

The semantic report is the tool for\u00a0identifying,\u00a0designating, and classifying medical devices and IVDs. This will be enhancing traceability and information exchange among stakeholders involved in product\u00a0commercialization;\u00a0it also contributes to\u00a0improving\u00a0regulatory compliance and market surveillance. For this standardization\u00a0<\/span>Colombia has adopted the Unique Device Identifier (UDI) codes<\/span>.<\/span>\u00a0<\/span><\/p>\n

\u00a0<\/span><\/p>\n

\u00a0<\/span><\/p>\n

Transitory Period\u00a0(completed)<\/span><\/b>\u00a0<\/span><\/h3>\n

\u00a0<\/span>\u00a0<\/span><\/p>\n

To allow the industry to adapt,\u00a0Resolution 1405 of 2022\u00a0established\u00a0a\u00a0phased transitory period\u00a0applicable to sanitary registrations and modifications\u00a0granted on or before February 7, 2024.<\/span>\u00a0<\/span><\/p>\n

\u00a0<\/span><\/p>\n

The transitional timelines were as follows:<\/span>\u00a0<\/span><\/p>\n

\u00a0<\/span>\u00a0<\/span><\/p>\n