: Medical devices are regulated by the ARCSA or Agencia Nacional de Regulación, Control y Vigilancia Sanitaria (National Health Regulation, Control, and Surveillance Agency). CLASSIFICATION SYSTEM:
Medical devices are classified according to the EU risk-based model into Classes I, IIa, IIb, III, and IV. TIMEFRAME:
As regulations in Ecuador are new, the timeframe for approval is uncertain. However, it is estimated that the process takes about three weeks for preliminary review with an additional 15 working days to review the hard copy submission. AUTHORIZED REPRESENTATIVE:
An authorized representative is required to register medical devices in Ecuador.
Last updated on March 17 2015.
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