Argentina – New ENACOM Standard for Medical Devices

Argentina Resolution 237/2024

On August 12, 2020 ENACOM officially released Resolution 863/2020 in conjunction with Testing Standard ENACOM-Q2-60.15 V19.1 regarding the approval of medical devices.

Highlights of the Resolution include:

  • Allocation of a new frequency band from 430 – 440MHz intended for Medical Capsule Endoscopy
  • Updated Technical Testing Standard for Radiocommunications System for Medical Use (ENACOM-Q2-60.15 V19.1) has become effective

Please note that at this time, there are no local laboratories accredited to perform testing under ENACOM-Q2-60.15 V19.1, so manufacturers may currently use a Declaration of Conformity without local testing.

If you have questions, please contact iCertifi.

 

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