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REGULATORY AUTHORITY: National Health Regulation, Control, and Surveillance Agency (ARCSA)
CLASSIFICATION SYSTEM:
Medical Devices/IVDs: I/II/III/IV
TIMEFRAME: New product registration will take around 2-6 months.
SPECIAL REQUIREMENTS: An authorized representative is required to register medical devices in Ecuador.
LOCAL FEES (New application):
Medical Devices and IVDs (new product registration): USD 905
Medical Devices and IVDs (license amendment): USD 95
Medical Devices and IVDs (renewal): USD 185
LOCAL FEES (Manufacturer): n/a
LICENSE VALIDITY:
Registration certificate: 5 years
LICENSE TRANSFER: License transfer is applicable and considered a minor change and does not require a new registration.
AUTHORIZED REPRESENTATIVE: Foreign manufacturers without an establishment in Ecuador are required to appoint a local company to act as an in-country representative.
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