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 (MD) Class I, low risk: Up to thirty (30) calendar days.

Medical Devices (MD) Class II, moderate risk: Up to sixty (60) calendar days.

Medical Devices (MD) Class III, high risk: Up to ninety (90) calendar days.

Medical Devices (MD) Class IV, critical risk: Up to ninety (90) calendar days.

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

All medical device registration applications are subject to review from regulatory authorities. Distributors must wait until formal review and approval are complete to begin importing and selling. Timeframes range from 1 to 6 months. If all goes according to plan, DIGEMID will issue a Directorial Resolution approving your device registration. The registration is valid for ten years.

Learn more about MD registration in Perú and contact us at 997556699 or by mail info@pharmaconsulting.pe