Regulatory Update – ColombiaCRC Publishes Resolution 7811/2025 to Streamline Telecom Rules
On June 16, 2025, the Comisión de Regulación de Comunicaciones (CRC) of Colombia issued Resolution 7811/2025, replacing the previous Resolution 5050/2016. This reform aims to modernize and simplify the telecom regulatory framework, increasing legal clarity and efficiency. Key Highlights: Over 90 articles revised, leading to the elimination or adjustment of around 190 regulatory measures, cutting […]
Regulatory Update – Chile Strengthens Rules for Immunohematological Reagents (Decree No. 5)
On February 4, 2025 (published February 21), Chile’s Ministry of Health approved Decree Exento No. 5, formally incorporating immunohematological reagents into the country’s sanitary regulatory framework. The regulation will take effect on February 22, 2026. Key Requirements: Mandatory Certification under NCh-ISO 16142/2:2021, with sensitivity and specificity testing overseen by the Public Health Institute (ISP). Risk […]
Regulatory News – ArgentinaArgentina Implements New MERCOSUR Medical Device Regulation
As of January 2025, Argentina has officially adopted the new MERCOSUR Technical Regulation for Medical Device Registration (GMC Resolution No. 25/21), replacing the previous Resolution No. 40/00. Key Highlights: Harmonized Requirements across MERCOSUR countries (Argentina, Brazil, Paraguay, Uruguay, and Bolivia) to reduce inconsistencies and simplify the registration process. Acceptance of Foreign Data, allowing the use […]
