🇪🇨Ecuador Medical Device Regulations

Substitute Medical Device Registration, Control and Surveillance Regulation

New substitute technical health regulation for medical device registration, control, and surveillance. Published in May 2026 with a nine-month transition period before it replaces the prior framework.

Medical Device Sanitary Registration and Control Regulation

Current framework for sanitary registration, quality, safety, efficacy, surveillance, and control of human-use medical devices and the establishments that manufacture, import, distribute, or sell them.

Advertising and Promotion Controls for Medical Devices

Sets post-market controls for advertising and promotion, including over-the-counter medical devices, and requires claims to remain consistent with the approved sanitary registration.