WTO notification · TBT
ColombiaProposed measure, not in force yet
Draft Decree 'By which the sanitary regime applicable to medical devices is established, the rules for their marketing authorization, surveillance and sanitary control are defined, and other provisions are dictated'
Proyecto de Decreto 'Por el cual se establece el régimen sanitario aplicable a los dispositivos médicos, se definen las reglas para su autorización de comercialización, vigilancia y control sanitario, y se dictan otras disposiciones'
Colombia notified this proposed TBT measure to the WTO on 18 May 2026. The comment period closed on 17 July 2026.
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Source: WTO ePing (opens in a new tab). Summaries by Expodite, which is independent of the WTO.
Published here:
Medical devices for human use, including In Vitro diagnostic reagents (IVDMD), patient-matched medical devices and adaptable medical devices. Components, parts, accessories and software, when they are part of a medical device, are used togethe
Dispositivos médicos para uso humano, incluidos los reactivos de diagnóstico In Vitro (DMDIV), dispositivos médicos adaptados al paciente y dispositivos médicos adaptables. Los componentes, partes, accesorios y programas informáticos, cuando formen parte de un dispositivo médico, se utilicen juntame
The comment period closed on 17 July 2026. You can still raise concerns about the measure with your country's WTO TBT enquiry point, quoting the document symbol G/TBT/N/COL/276; it can take them up with Colombia.
Find your country's enquiry point on WTO ePing (opens in a new tab)The draft decree establishes the new sanitary regime applicable to medical devices for human use and in vitro diagnostic medical devices in Colombia, including provisions relating to manufacturing, importation, marketing, conditioning, storage, labelling, sanitary surveillance and conformity assessment. The measure incorporates a regulatory framework based on the risk level of medical devices and defines requirements applicable to the granting, amendment, renewal and cancellation of the corresponding sanitary authorizations. It also establishes provisions relating to Good Manufacturing Practices (GMP), Certificates of Storage and Conditioning Capacity (CCAA), G/TBT/N/COL/276- 2 - post-market surveillance, traceability, and the obligations of manufacturers, importers and other actors in the supply chain.The draft seeks to ensure the quality, safety and performance of medical devices with the objective of minimizing risks to human health and safety, as well as protecting persons who use such devices.
Expodite writes its summary from the official record. The notification and the documents it notifies are on the WTO's own websites.
WTO notificationSPSAdopted, according to its latest noticeNew
Colombia issued an addendum on 9 November 2026 to the earlier SPS notification G/SPS/N/COL/381. Addenda often report that a measure was adopted, changed, postponed or withdrawn. The measure was first notified on 8 May…
Symbol: G/SPS/N/COL/381/Add.2Comment period closed
WTO notificationSPSEmergency measure, may already applyEmergencyNew
Colombia notified this emergency SPS measure on 2 November 2026. Emergency measures can apply immediately.
Symbol: G/SPS/N/COL/441
WTO notificationSPSProposed measure, open for commentsNew
Colombia notified this proposed SPS measure to the WTO on 26 October 2026. Comments are open until 25 December 2026.
Symbol: G/SPS/N/COL/440Comments until 25 December 2026
WTO notificationSPSProposed measure, open for commentsNew
Colombia notified this proposed SPS measure to the WTO on 26 October 2026. Comments are open until 25 December 2026.
Symbol: G/SPS/N/COL/439Comments until 25 December 2026
Expodite matches each notification to the markets you export to and the HS codes of your products, and puts the ones that concern you in your Updates centre, with the date comments close.