ORBIS Compliance

Argentina Approves Laboratory for Medical Device Testing

Published /Argentina

Overview

On 09/01/21, Argentina’s Ente Nacional de Comunicaciones (ENACOM) released Resolución 1248/2021.

This resolution approves one of the laboratories in Argentina to test medical devices with cellular device bands.

Maximum Allowed Output Power Per Band

  • Band 9 - 315 kHz: 30 dBµA/m @ 10m in EPZA
  • Band 30 - 37.5 MHz: 150,000 µV/m @ 3 m in EPZA
  • Band 401-406 MHz: 18,260 µV/m @ 3 m in EPZA
  • Band 430-440 MHz: 1,480 µV/m @ 3 m in EPZA

Before this resolution, ENACOM allowed manufacturers to use Department of Compliance to certify these devices. ENACOM will continue to accept documentation until 03/01/22. After this date, local testing will be mandatory.

For more information please contact info@orbiscompliance.com - mailto:info@orbiscompliance.com or (408) 465-7331.

Argentina Quick Facts

Regulatory AgencyENACOM (Ente Nacional de Comunicaciones)
Certification TypeMandatory
License Validity3 Years
Application LanguageSpanish
Legal License HolderRequired
In-country Testing RequirementDepending on the product

Talk to our Experts

Let us clarify how this news impacts you. Fill the form below and we will get back to you within 24 hours.

Gain comprehensive insights and the latest regulatory updates from around the globe with ORBIS Compliance's product certification management resources. Discover how to utilize these tools by completing our brief contact form for more information.