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...
Read MoreAndean Community bans Bimatoprost in cosmetics over health concerns
May-08-2026
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....
Read MoreEcuador 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...
Read MoreEcuador'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...
Read MoreEcuador 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...
Read MoreEcuador 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...
Read MoreEcuador Publishes Draft Framework to Streamline Health Product Registration
Jul-22-2025
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,...
Read MoreEcuador 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...
Read MoreEcuador 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...
Read MoreEcuador Updates Registration Guidelines for Hygienic and Disinfectant Products
Jan-13-2025
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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