Simplifying Medical Device Registration with DIGEMID

With a population surpassing 34 million and an increasing health sector budget, Peru emphasizes healthcare system improvement as a national priority. This focus, coupled with regulatory requirements for medical devices, underscores the importance of understanding local regulations for successful market entry.

Device Classification and Regulatory Pathways

Complying with Peruvian Regulations

Regulatory Authority

In Peru, the General Directorate of Drugs, Supplies and Drugs (DIGEMID) oversees the registration and regulation of medical devices. A sanitary registration is mandatory for selling medical devices in Peru, with classification into risk classes I through IV based on a rule-based system that determines the regulatory pathway for each product.

Classification

Medical devices are classified according to their risk level, from Class I (low risk) to Class IV (high risk). This classification guides the documentation and procedures required for sanitary registration.

Key Requirements

To market medical devices in Peru, foreign manufacturers must:

  • Appoint a local Holder responsible for the registration of products with DIGEMID.
  • Prepare and submit a comprehensive technical dossier to meet the regulatory requirements for the specific class of the device.
How We Can Help

Tailored Support for Market Entry

Our expertise is designed to streamline your regulatory compliance and market entry in Peru:

  • Assistance with product classification and identification of the appropriate regulatory pathway.

  • Support in compiling the technical submission required for DIGEMID registration.

  • Acting as your Holder, managing the registration process and ensuring compliance with post-market requirements.

We Provide Access To 28+ Markets Worldwide

Our team of experts and local representatives, supported by partnerships with hundreds of clinical labs and the extensive GRIP database for over 100 countries, accelerates product launches and ensures compliance across 28 countries.

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Whether looking for more information or ready to partner with us, we're here to guide you through every step of the regulatory process.

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