DIGEMID decreases the period of evaluation for the sanitary registration of medical devices in Peru

The National Authority of Pharmaceutical Products, Medical Devices and Health Products has reduced the maximum period of evaluation for the inscription and reinscription of medical devices in the peruvian sanitary registry.

  • Medical Devices (DM) Class I (low risk): up to thirty (30) calendar days
  • DM Class II (moderate risk): up to sixty (60) calendar days
  • DM Class III (high risk): up to ninety (90) calendar days
  • DM Class IV (critical risk): up to ninety (90) calendar days

With this modification to the current regulations, manufacturers and importers are expected to reduce the time to market their products.



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