Ecuador Amendments as regards importers' registration, medicinal products and related products

A sanitary registration of medicines, medical devices, natural products for medicinal use and hygiene products with the National Agency of Sanitary Regulation, Control and Surveillance (ARCSA) assigned to the Ministry of Public Health (MSP) is mandatory for the importation of these commodities. For cosmetic products, an import notification is to be submitted to the ARCSA prior to the actual importation.

Importers applying for inscription of a specific product into the respective sanitary register are required to submit detailed supporting documentation. For example, some goods subject to sanitary registration require a document certifying that microbiological, physical or chemical tests have been carried out by an appropriate laboratory in the country of export. For the importation and marketing of medical devices, importing companies subject to sanitary monitoring must comply with the technical sanitary norm, i.e. Resolution ARCSA-DE-021-2020-MAFG, in order to obtain an operating permit from the ARCSA.

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