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Medical Device Registration and Approval in Ecuador
General country-specific regulatory information is provided on this page for medical device registration and approval in Ecuador.
Last updated on February 16th, 2022.
Medical Device Regulations and Classification in Ecuador
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.
For detailed device-specific compliance information for each market, including Ecuador, to expedite the preparation of your medical device or IVD registration application.
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