Sanitary Registration Applications

The Chilean Public Health Institute (Instituto de Salud Publica - ISP) has announced that starting on March 16th, 2022, applications for sanitary registration of portable automatic external defibrillators can be submitted. Law No. 21,156 mandates that this equipment must be available in certain establishments and venues.

Role of ISP

The ISP, through the National Agency for Medical Devices, Innovation, and Development (ANDID), is responsible for ensuring the safety and performance of medical devices. This is accomplished through control, inspection, and surveillance activities throughout the product lifecycle. Consequently, obtaining sanitary registration for portable automatic external defibrillators will take place via their online platform, adhering to the guidelines of the Sanitary Registry of Medical Devices Under Sanitary Control. Moreover, for portable automatic external defibrillators specifically, the health registration process will also involve verifying the conformity of the medical device.