ORBIS Compliance

Peru's MTC Issues New Regulations for Medical Devices

Published /Peru

February 12, 2020

On February 12, 2020, the Ministry of Transport and Communications of Peru (MTC) published Supreme Decree No. 003-2020-SA, which approves new regulations establishing classification rules and the essential principles of safety and performance for medical devices.

Key Components of the Supreme Decree

The integral part of this Supreme Decree includes:

  • Three (3) titles
  • Ten (10) articles
  • Two (2) final complementary provisions
  • Two (2) annexes

This decree provides important information regarding general provisions, classification rules, safety, and performance of medical equipment.

Important Notice

The Supreme Decree will come into effect six (6) months from the day following its publication.

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Peru Quick Facts

Regulatory AgencyMinisterio de Transportes y Comunicaciones (MTC)
Certification TypeMandatory
License ValidityIndefinite
Application LanguageSpanish
Legal License HolderRequired
In-country Testing RequirementNo testing required

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