Registration requirements: All medical devices must be registered with the National Agency for Regulation, Control, and Health Surveillance of Ecuador (ARCSA). Registration requirements include product technical documents, manufacturing license, quality management system, labels, instructions, and samples.

License requirements: All medical devices require a medical device license in Ecuador to be sold in the market. The license application requirements include a registration certificate, manufacturing license, product instructions, and other relevant documents.

Customs requirements: All imports of medical devices must comply with Ecuador's customs regulations, including providing product information, product pricing, and the identity of the importer.

Labeling requirements: All medical devices must have information such as the product name, usage, manufacturing date, expiration date, and the name and address of the manufacturer marked on the packaging.

Ecuador's medical device classification rules are based on their function, use, and risk level. ARCSA classifies medical devices into 4 categories, with the first category being the lowest risk and the fourth category being the highest risk. The classification of a medical device determines its registration, license, and other market access requirements.