Ecuador

Ministry of Health

Ministry of Public Health

Regulatory Authority

National Agency for Sanitary Regulation, Control and Surveillance (ARCSA)

Medical Device Regulation

• Resolution ARCSA-DE-021-2020-MAFG – Issuance of the operating permit to establishments that manufacture, import, store, distribute, market and transport medical devices
• IE-B.3.2.1-DM-01 Requirements for registration, re-registration and modification of the health registration of medical devices for human use

Official Language

Spanish

Classification

Class I, II, III and IV

Registration Process

• Determine the device classification
• Appoint an authorized representative
• Prepare the application form and technical documentation
• The Authorized Representative submits the technical documentation to the ARCSA.
• Once approved, the medical device can be marketed in Ecuador