DIGEMID Peru Medical Device Registration
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 DIGEMID Peru medical device registration requirements, underscores the importance of understanding local regulations for successful market entry.
Complying with Peruvian Regulations
Regulatory Authority
The General Directorate of Medicines, Supplies and Drugs (DIGEMID) is the medical device regulator in Peru. Pure Global can assist with Peru medical device registration and provide local representation, ensuring DIGEMID approval to sell in the Peruvian market.
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.
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.
Frequently
Asked Questions
What is the primary regulatory authority for medical device registration in Peru?
The primary regulatory authority for Peru medical device registration is DIGEMID (Dirección General de Medicamentos, Insumos y Drogas). Pure Global can assist with navigating the registration process to ensure DIGEMID approval for selling medical devices in the Peruvian market.
How are medical devices classified in Peru?
Medical devices in Peru are classified according to their risk level into four classes according to Peru medical device regulations: • Class I: Low risk • Class II: Moderate risk • Class III: High risk • Class IV: Very high risk This classification determines the documentation and procedures required for sanitary registration.
What are the key requirements for foreign manufacturers to market medical devices in Peru?
Foreign manufacturers must: 1. Appoint a local Holder responsible for the registration of products with DIGEMID. 2. Prepare and submit a comprehensive technical dossier that meets the regulatory requirements for the specific class of the device.
How does the classification of a medical device impact the registration process in Peru?
The classification of a medical device impacts the registration process by determining the level of documentation and regulatory procedures required by DIGEMID Peru. Higher-risk devices (Class III and IV) generally require more extensive documentation and rigorous procedures compared to lower-risk devices (Class I and II).
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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.