REGULATORY & MARKET-ENTRY SERVICES

Your Partner for Healthcare Market Entry in Peru

IzzoMed provides regulatory and market-entry services in Peru for international healthcare manufacturers. We support each stage of market entry, from initial product assessment and regulatory strategy to sanitary registration, local representation, importation, logistics and commercial development.

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◉  Regulatory expertise◉  Local representation◉  Market access
Servicios regulatorios y comerciales en Perú - IzzoMed
OUR SERVICES

Integrated Capabilities for Healthcare Market Entry in Peru

We combine regulatory expertise, local operational capabilities and commercial knowledge to help healthcare companies enter and develop the Peruvian market.

From regulatory assessment and sanitary registration to local representation, importation, storage and commercial development, we coordinate the capabilities required for each market-entry project.

Explore our specialized services for medical device registration, pharmaceutical registration y regulatory affairs in Peru.

3+
years of experience
Global
enfoque internacional
360°
project perspective
Medical Device Registration en Perú

Medical Device Registration

End-to-end support for the assessment, documentation and sanitary registration of medical devices in Peru.

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Registro sanitario de medicamentos en Perú

Pharmaceutical Registration

Regulatory support for pharmaceutical manufacturers seeking to register and develop their products in the Peruvian market.

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Regulatory Affairs en Perú

Regulatory Affairs

Requirements assessment, regulatory strategy, dossier preparation and regulatory follow-up before DIGEMID.

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Local Representation & Importation

Local representation and coordination of importation, storage and distribution for healthcare projects.

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HOW WE WORK

A Structured Market-Entry Process

We support projects from initial assessment through commercial development, coordinating the relevant regulatory and operational activities.

1

Product
assessment

2

Regulatory strategy

3

Registration / authorization

4

Local representation

5

Importation
& logistics

6

Desarrollo
comercial

FOR INTERNATIONAL MANUFACTURERS

Your Local Platform in the Peruvian Market

We work with international healthcare manufacturers seeking a reliable local partner to introduce and develop their products in Peru.

Our involvement can begin at the initial assessment and documentation stage and continue through regulatory management, local representation, importation and commercial execution.

One Local Partner. Multiple Capabilities.

✓ Knowledge of the Peruvian regulatory environment

✓ Support for international manufacturers

✓ Coordination of regulatory and operational services

✓ Long-term approach to the Peruvian market

WHY IZZOMED?

Local Expertise. International Perspective.

Experience in Peru

Knowledge of Peru’s regulatory environment and local healthcare system.

Soporte internacional

Support designed for international manufacturers and healthcare companies.

Soluciones integrales

From regulatory affairs to commercial and operational coordination.

Aliado a largo plazo

Long-term support for building a sustainable presence in Peru.

ENTER THE PERUVIAN MARKET

Planning a Project in Peru?

Tell us about your product and we will assess the regulatory, operational and commercial pathway for entering the Peruvian market.

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INNOVATION
REGULATORY ACCESS
BETTER HEALTHCARE ACCESS IN PERU
INFORMATION FOR HEALTHCARE COMPANIES

Regulatory and Commercial Services in Peru: Frequently Asked Questions

Our regulatory and commercial services in Peru are designed for manufacturers, product holders and international companies that need to assess applicable requirements before beginning operations. We review each project according to product type, classification, available documentation and market-entry model.

What Do We Review Before Starting?

We assess technical and commercial information, identify preliminary requirements, review manufacturer documentation and define the activities required for registration, local representation or importation. This helps establish priorities and anticipate potential documentation issues.

Do We Support International Manufacturers?

Yes. We coordinate with international manufacturers and companies, facilitate documentation review and explain the steps that may apply before the Peruvian health authority. The scope is defined according to the product and agreed responsibilities.

Where Can Official Information Be Consulted?

Requirements should be verified against official information from DIGEMID and the regulations applicable to each product category. IzzoMed supports operational interpretation and dossier preparation without replacing the requirements established by the competent authority.

What Is the Next Step?

Send us information about the product, manufacturer, country of origin and commercial objective in Peru. We can then review the initial scope and discuss an appropriate market-entry pathway.