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.

We review our Regulatory Information frequently; please check back often for updates

Medical Device Regulations and Classification in Ecuador

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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.

Other South American Countries: ArgentinaBrazilChileColombiaPeruUruguayVenezuela

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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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Did you know you can onboard your medical device or IVD compliance information to our system in less than 15 minutes?

And, in less than a minute, you can start your device-specific registration application and a complete county-specific registration process in this country or any of the other 140+ countries available for you through the Arazy Group Medtech registration platform.

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