Medical Devices - Ecuador

The National Agency for Regulation, Control and Sanitary Surveillance – ARCSA, recognizes the Sanitary Registry, coming from authorities of high sanitary surveillance, and which, in turn, are members of the Management Committee of the International Forum of Medical Device Regulators – IMDRF; These countries are: United States of America, Canada, Australia, Japan, countries with high health surveillance in the European Union, Republic of South Korea.

With the expertise of the company’s regulatory team, we advise you on the strategy that your company needs so that our clients’ products obtain the necessary permits for the commercialization of the products.

In Ecuador, Medical Devices are defined as instruments, apparatus, artifacts or mechanical inventions, including their components, parts or accessories, manufactured, sold or recommended for use in diagnosis, curative or palliative treatment, prevention of a disease, disorder or condition. abnormal physique or its symptoms, to replace or modify or control anatomy or a physiological process. They include amalgam fillings, varnishes, sealants, and more similar dental products.

Who is it for?

The beneficiary of the Issuance of Sanitary Registration Certificate for medical devices by homologation may be any company name that has a Unique Taxpayer Registry (RUC) of a Natural or Legal Person, National or Foreign.
Addressed to: Legal Entity – Private, Legal Entity – Public, Natural Entity – Ecuadorian, Natural Entity – Foreigner.

The company’s regulatory team will accompany you in relation to the classification of the product, in the organization and radiation management in ARCSA of the dossiers so that they comply with Ecuadorian regulations.