Luis Fuentes, a finance specialist and international business expert, serves as Corporate Affairs Director at Alligare International LLC and leads Estudio Fuentes. With over 10 years of experience, he excels in financial advisory, business internationalization, and strategic corporate solutions, helping companies in Latin America, Europe, and Asia expand globally.
Learn about sanitary registration in Peru, its requirements, and regulatory process for food, beverages, and medical devices.
Table of Contents
Introduction to sanitary registration in Peru?
As an expert in regulatory compliance and business strategies in Peru, I aim to provide valuable insights into sanitary registration. My experience working with companies navigating complex legal frameworks allows me to break down this process clearly and effectively. Understanding this process is crucial for businesses aiming to comply with local health and safety standards.
What is sanitary registration in Peru?
Sanitary registration in Peru is a regulatory process that ensures the safety and quality of medical devices, food, and beverages. This process involves compliance with strict sanitation and public health measures to prevent risks associated with unsafe products. This system is supervised by the Ministry of Health through two primary entities:
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The Dirección General de Medicamentos, Insumos y Drogas (DIGEMID), which oversees the registration and control of medical devices.
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The Dirección General de Salud Ambiental e Inocuidad Alimentaria (DIGESA), responsible for food and beverage sanitary registration.
Recent studies, such as the research by Rojas Mezarina and Silva-Valencia (2020), emphasize the urgent need for a more specific regulatory framework in Peru, particularly for new health technologies like mobile health applications and digital medical devices.
What is the sanitary registration process for medical devices in Peru?
DIGEMID is responsible for issuing, renewing, modifying, suspending, and canceling medical device sanitary registrations. It ensures that all medical devices entering the Peruvian market adhere to global regulatory and licensure standards.
How to obtain sanitary registration for medical devices in Peru?
This process involves classifying the device’s risk level, preparing technical documentation, submitting an application to DIGEMID, and undergoing regulatory evaluation before approval.
To acquire sanitary registration, manufacturers and importers must follow these steps:
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Determine the risk classification of the device (Class I, II, III, or IV).
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Prepare the required documentation, including:
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Technical specifications of the device.
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Safety and performance evaluations.
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Certificate of Free Sale from the country of origin.
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Submit the application to DIGEMID, ensuring all documentation is complete.
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Await regulatory evaluation and approval, which may involve additional inspections or requirements.
The implementation of the U.S.-Peru Free Trade Agreement (TLC) has significantly influenced the regulatory environment for pharmaceuticals and medical devices in Peru. Seoane-Vazquez et al. (2021) found that the agreement led to changes in market access regulations, making it easier for U.S.-approved products to enter the Peruvian market while increasing competition.
What is the sanitary registration process for food and beverages in Peru?
DIGESA is responsible for regulating food and beverage sanitary registration, ensuring compliance with microbiological, chemical, and labeling regulations. This includes overseeing food safety policies and sanitation protocols to protect consumers.
How to obtain sanitary registration for food and beverages in Peru?
This process requires submitting an application with full product details, ensuring compliance with microbiological and chemical safety standards, and obtaining necessary regulatory approvals from DIGESA before commercialization.
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Submit a sworn application that includes:
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Full product description.
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Manufacturing and packaging details.
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Compliance with microbiological and chemical safety standards.
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Provide a Certificate of Free Sale, demonstrating that the product is legally sold in the country of origin.
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Comply with Peru’s Healthy Eating Law, which requires specific labeling for products with high sugar, sodium, or fat content.
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Undergo product evaluation and approval by DIGESA before commercialization.
A study conducted by Ramirez-Hernandez et al. (2021) revealed alarming contamination levels in Peruvian produce, with over 70% of vegetables exceeding the safe limits for heavy metals like lead and arsenic. This underscores the importance of strict sanitary oversight in food production and distribution.
What are the requirements to import food and beverages to Peru?
To import food and beverages, companies must adhere to DIGESA’s requirements and provide the following:
How to obtain sanitary registration for imported food and beverages in Peru?
This process involves obtaining a Certificate of Free Sale, registering the importer and manufacturer with DIGESA, ensuring compliance with local food safety regulations, and submitting documentation for approval before distribution.
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Obtain a Certificate of Free Sale from the exporting country’s health authority.
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Register the importer and manufacturer with DIGESA.
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Ensure compliance with Peruvian food safety regulations, which may involve laboratory testing and labeling adjustments.
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Submit all documentation for DIGESA approval before distribution in the local market.
Government initiatives have reinforced sanitary inspections in local food markets to uphold public health standards and improve compliance with regulatory frameworks. to mitigate health risks and improve hygiene conditions. Ton et al. (2023) highlighted that the Peruvian government intensified sanitary control measures in public markets during the COVID-19 pandemic to prevent foodborne diseases and contamination.
Frequently Asked Questions (FAQs) about sanitary registration in Peru
Before diving into the frequently asked questions, it’s essential to understand that sanitary registration in Peru is a complex process that involves multiple regulatory bodies and compliance requirements. This section aims to clarify key doubts and provide accurate information to help businesses and individuals navigate the system efficiently.
What is the FDA equivalent in Peru?
In Peru, the Dirección General de Medicamentos, Insumos y Drogas (DIGEMID) serves as the equivalent of the FDA, regulating medical devices, pharmaceuticals, and other health-related products.
What are the requirements for food labeling in Peru?
Food products in Peru must comply with DIGESA’s food labeling regulations, including nutritional information, expiration dates, and warnings for high sugar, sodium, or fat content under Peru’s Healthy Eating Law.
How are medical devices classified in Peru?
Medical devices in Peru are classified into four risk levels (Class I, II, III, and IV) based on their potential impact on health. Higher-risk devices require more extensive documentation and regulatory approvals.
How to register a company in Peru for food and beverage imports?
Businesses importing food and beverages must register with DIGESA, obtain a Certificate of Free Sale, and comply with Peru’s food safety and labeling regulations before entering the market.
Conclusion
Ensuring compliance with Peru’s sanitary registration processes is fundamental for businesses operating in the food, beverage, and medical device industries. Navigating these regulatory frameworks efficiently can help companies avoid legal complications and foster consumer trust. By staying informed about evolving regulations and leveraging expert guidance, businesses can secure market access and maintain high safety standards.
You can contact me (Luis Fuentes) and Estudio Fuentes if you want to speak with an expert on this topic.
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