Mandatory Testing For Medical Devices

The Argentinian authority ENACOM released ResoluciΓ³n 1248/2021, which will become effective in 180 days, on March 1, 2022.

This is due to a new certification site being approved in the country and will be required for medical testing.

There are also changes to the following standards:

  1. Technical Standard ENACOM-Q2-60.15 V19.1 "Medical Devices".
  2. Technical Standard ENACOM-Q2-61.03 V17.1 "User Terminal Equipment for Mobile Communications ".
  3. -Technical Standard ENACOM-Q2-61.04 V17.1 "Base Radio Transceivers of the Services of Mobile Communications "

Until the deadline passes, manufacturers are currently allowed to approve their medical devices with a DoC including: Manufacturer name and address, Product description (brand, model, specification and other details), using reference to compliance to ENACOM-Q2-60.15 standard, date and signatory name/surname/position.

Thinking about compliance testing and certification?

Contact us today for a free consultation or more information.

Get In Touch