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Ecuador has three main documents that together establish the rules for chemical industry in the country:
- Technical Regulation 078 on transport, storage, and management of hazardous materials
- Acuerdo Ministerial 099 on instructions for the registration of hazardous chemical substances and environmental obligations
- Decreto 752/2019 that states the creation of a chemical inventory and a chemical registry
Additionally, Ecuador is part of the Andean Community, which indicates that the communal regulation for chemical pesticides for agriculture is in place (Resolución 2.075/2019).
News
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Ecuador Issues Sweeping New Rules for Medical Devices, Replacing Decade-Old Framework
Ecuador's health regulatory authority has issued one of the most comprehensive overhauls of its medical device framework in nearly a decade, signing into law a new technical standard that will govern...
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Ecuador's Health Regulator Moves to Tighten Controls Over Medicines, Medical Devices and Market Access
ARCSA announces sweeping reforms to manufacturing and operational standards as part of its 2026 regulatory agenda Ecuador's National Agency for Health Regulation, Control and Surveillance, known as ARCSA, has unveiled a...
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