ORBIS Compliance

New Rule on Importation of Used Medical Equipment Introduced

Published /Argentina

New Regulation on Medical Equipment Importation

On March 1st, 2019, a new rule No. 2043/2019 was published, affecting the importation of used medical equipment.

  1. This rule impacts requests for authorization to import medical devices, including used medical devices and those used for diagnostic or in-vitro purposes.
  2. It revokes disposition 3829/12.
  3. A different virtual platform has been implemented to facilitate this process.
  4. The rule outlines the timeframe for validating approved requests.
  5. It specifies the duration for addressing corrections and observations made by the competent authority.

This new disposition will come into force effective on the publication date in the official bulletin (06/Mar/2019).

For any clarification or guidance on this new regulation, please contact us at 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

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