WTO notification · TBT
ChileUpdated: check whether it is now adopted or in force
INCORPORATES THE PRODUCTS INDICATED INTO THE SANITARY CONTROL REGIME ESTABLISHED IN ARTICLE 111 OF THE SANITARY CODE AND IN SUPREME DECREE NO. 825 OF 1998, OF THE MINISTRY OF HEALTH.
INCORPORA LOS PRODUCTOS QUE INDICA AL REGIMEN DE CONTROL SANITARIO ESTABLECIDO EN EL ARTÍCULO 111 DEL CÓDIGO SANITARIO Y EN EL DECRETO SUPREMO Nº 825 DE 1998, DEL MINISTERIO DE SALUD.
Chile issued an addendum on 24 March 2026 to the earlier TBT notification G/TBT/N/CHL/762. Addenda often report that a measure was adopted, changed, postponed or withdrawn. The measure was first notified on 17 November 2025. The comment period closed on 16 January 2026.
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39 categories of medical devices distributed in: IVDMD (In Vitro Diagnostic Medical Devices): IVDMD for detection of Helicobacter pylori (Class C); Human Papillomavirus - HPV detection tests (Class C); respiratory virus detection tests (Influenza A/B, RSV, Parainfl
39 categorías de dispositivos médicos distribuidos en: DMDIV (Dispositivos Médicos de Diagnóstico In Vitro): DMDIV para detección de Helicobacter pylori (Clase C); Pruebas de detección de Virus Papiloma Humano - VPH (Clase C); Pruebas de detección de virus respiratorios (Influenza A/B, VRS, Parainfl
The comment period closed on 16 January 2026. You can still raise concerns about the measure with your country's WTO TBT enquiry point, quoting the document symbol G/TBT/N/CHL/762/Add.1; it can take them up with Chile.
Find your country's enquiry point on WTO ePing (opens in a new tab)Latest notice (G/TBT/N/CHL/762/Add.1, 24 March 2026)
Incorporating the listed products into the health control system established pursuant to Article 111 of the Health Code and Supreme Decree No. 825 of 1998, of the Ministry of Health
1. OBJECTIVE OF THE REGULATORY PROPOSAL Incorporate into the sanitary control regime established in Article 111 of the Sanitary Code and in Supreme Decree No. 825 of 1998 of the Ministry of Health (Ministerio de Salud, MINSAL), a set of 39 medical devices (MD) and in vitro diagnostic medical devices (IVDMD), through the implementation of a conformity verification system based on ISO/IEC international standards. Specific objectives: Guarantee the quality, safety and performance of critical medical devices used in the Chilean health system; Prioritize the control of higher-risk devices (Classes III and IV for MD; Classes C and D for IVDMD); Align national regulation with WHO recommendations and international standards; Protect patient safety through controls proportional to risk
1. OBJETIVO DE LA PROPUESTA REGLAMENTARIA Incorporar al régimen de control sanitario establecido en el artículo 111 del Código Sanitario y en el Decreto Supremo Nº 825 de 1998 del Ministerio de Salud, un conjunto de 39 dispositivos médicos (DM) y dispositivos médicos de diagnóstico in vitro (DMDIV), mediante la implementación de un sistema de verificación de conformidad basado en normas internacionales ISO/IEC. Objetivos específicos: Garantizar la calidad, seguridad y desempeño de dispositivos médicos críticos utilizados en el sistema de salud chileno; Priorizar el control de dispositivos de mayor riesgo (Clases III y IV para DM; Clases C y D para DMDIV); Alinear la regulación nacional con las recomendaciones de la OMS y estándares internacionales; Proteger la seguridad de los pacientes mediante controles proporcionales al riesgo
Every notice about this measure published here, newest first. Each one is the notifying member's own text.
AddendumG/TBT/N/CHL/762/Add.1
Incorporating the listed products into the health control system established pursuant to Article 111 of the Health Code and Supreme Decree No. 825 of 1998, of the Ministry of Health
Regular notificationG/TBT/N/CHL/762
Comment deadline: Closed on 16 January 2026
INCORPORATES THE PRODUCTS INDICATED INTO THE SANITARY CONTROL REGIME ESTABLISHED IN ARTICLE 111 OF THE SANITARY CODE AND IN SUPREME DECREE NO. 825 OF 1998, OF THE MINISTRY OF HEALTH.
INCORPORA LOS PRODUCTOS QUE INDICA AL REGIMEN DE CONTROL SANITARIO ESTABLECIDO EN EL ARTÍCULO 111 DEL CÓDIGO SANITARIO Y EN EL DECRETO SUPREMO Nº 825 DE 1998, DEL MINISTERIO DE SALUD.
1. OBJECTIVE OF THE REGULATORY PROPOSAL Incorporate into the sanitary control regime established in Article 111 of the Sanitary Code and in Supreme Decree No. 825 of 1998 of the Ministry of Health (Ministerio de Salud, MINSAL), a set of 39 medical devices (MD) and in vitro diagnostic medical devices (IVDMD), through the implementation of a conformity verification system based on ISO/IEC international standards. Specific objectives: Guarantee the quality, safety and performance of critical medical devices used in the Chilean health system; Prioritize the control of higher-risk devices (Classes III and IV for MD; Classes C and D for IVDMD); Align national regulation with WHO recommendations and international standards; Protect patient safety through controls proportional to risk
1. OBJETIVO DE LA PROPUESTA REGLAMENTARIA Incorporar al régimen de control sanitario establecido en el artículo 111 del Código Sanitario y en el Decreto Supremo Nº 825 de 1998 del Ministerio de Salud, un conjunto de 39 dispositivos médicos (DM) y dispositivos médicos de diagnóstico in vitro (DMDIV), mediante la implementación de un sistema de verificación de conformidad basado en normas internacionales ISO/IEC. Objetivos específicos: Garantizar la calidad, seguridad y desempeño de dispositivos médicos críticos utilizados en el sistema de salud chileno; Priorizar el control de dispositivos de mayor riesgo (Clases III y IV para DM; Clases C y D para DMDIV); Alinear la regulación nacional con las recomendaciones de la OMS y estándares internacionales; Proteger la seguridad de los pacientes mediante controles proporcionales al riesgo
Expodite writes its summary from the official record. The notification and the documents it notifies are on the WTO's own websites.
WTO notificationSPSProposed measure, open for commentsNew
Chile notified this proposed SPS measure to the WTO on 6 November 2026. Comments are open until 5 January 2027.
Symbol: G/SPS/N/CHL/899Comments until 5 January 2027
WTO notificationSPSIn force, according to its latest noticeNew
Chile issued an addendum on 30 October 2026 to the earlier SPS notification G/SPS/N/CHL/897. Addenda often report that a measure was adopted, changed, postponed or withdrawn. The measure was first notified on 28 August…
Symbol: G/SPS/N/CHL/897/Add.1
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Symbol: G/TBT/N/CHL/586/Add.2Comment period closed
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Chile notified this proposed TBT measure to the WTO on 21 October 2026. Comments are open until 20 December 2026.
Symbol: G/TBT/N/CHL/807Comments until 20 December 2026
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