Ecuador updates NSO guidance for cosmetics and hygiene products

Ecuador’s health regulator, ARCSA, has updated its external guidance on the documentation companies must submit to obtain, renew, recognise or modify the Notificación Sanitaria Obligatoria, or NSO, for cosmetic products, household...

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Andean Community bans Bimatoprost in cosmetics over health concerns

The General Secretariat of the Andean Community has prohibited the use of Bimatoprost as an ingredient in cosmetic products sold across the bloc, citing potential health risks and its pharmacological action....

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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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Ecuador Implements Stricter Regulations for Pharmaceutical and Medical Device Storage and Distribution

Ecuador's National Health Regulatory Agency (ARCSA) has introduced on the 31st of March 2026 new certification requirements for pharmaceutical and medical device establishments, focusing on Good Storage, Distribution, and Transport Practices...

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Ecuador publishes Draft Rules Aiming to Tighten Cosmetic Safety and Labeling Standards

A new draft proposal published by the National Health Regulation Agency (ARCSA) in Equador sets out stricter requirements for cosmetics, aiming to boost consumer safety and ensure products on the market...

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Ecuador Publishes Draft Framework to Streamline Health Product Registration

The Ecuadorian National Agency for Regulation, Control, and Health Surveillance (ARCSA) has issued a resolution introducing new reforms to the technical sanitary regulations for the registration of health products. The reform,...

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Ecuador Implements New Sanitary Technical Regulations for Medicines

In a major regulatory move aimed at strengthening public health safeguards, the National Agency for Regulation, Control, and Sanitary Surveillance (ARCSA) has issued Resolution ARCSA-DE-2024-058-DASP, enacting new technical regulations for the...

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Ecuador Updates Regulations on Good Practices for Pharmaceutical and Medical Devices

The Republic of Ecuador has announced significant amendments to its Sanitary Technical Regulation on Good Practices for Storage, Distribution, and/or Transportation for pharmaceutical companies and manufacturers of medical devices for human...

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Ecuador Updates Registration Guidelines for Hygienic and Disinfectant Products

The National Agency for Regulation, Control, and Sanitary Surveillance (ARCSA) in Ecuador has released Version 2.0 of the External Instruction Document, which contains updated requirements for the registration, re-registration, and modification...

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