Medical Devices

The regulation of medical devices is undergoing big changes today. The medical device category can encompass millions of instruments and devices, including software.

What does the service consist of?

Support in the classification of the product as well as in the importation and commercialization to prevent sanitary infractions that may hinder the business.

Registro de Dispositivos Médicos en Chile

Record

Register your company if you are a manufacturer or importer of medical devices before the authority. GICONA code-Obtaining CDA.

Technovigilance

Corresponds to a set of activities for the prevention, detection, investigation and dissemination of adverse events with medical devices that may cause harm to the patient.

Sistemas Tecnovigilancia Chile