Argentina – New regulation for Medical Devices (401-406MHz)

ENACOM has published Resolution 4479-E/2017 which includes a new standard named “ENACOM-Q2-60.15 V17.1”. This resolution is now excluding medical devices working within 401-406 MHz range from the previous regulations covering low power devices.

Previously, ENACOM treated these devices as “Low Power Devices” and now they are treated as “Medical Devices to be used as part of a Radio Communication System for Medical Use”. Some examples of affected devices are: implantable pacemakers, implantable defibrillators, nerve stimulators, insulin meters and pumps.

Technical parameters and main information:

Band limits: 401 – 406 MHz

Bandwidth of emissions:

401 – 402 MHz: 100 kHz
402 – 405 MHz: 300 kHz
405 – 406 MHz: 100 kHz

Allowed devices:

401 – 402 MHz: Implantable, programmers and used in the body.
402 – 405 MHz: Implantable and programmers.
405 – 406 MHz: Implantable, programmers and used in the body.