Regulatory Medical Device Registration in Ecuador

  • REGULATORY AUTHORITY: 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: 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.