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Registration of medical devices in Peru It requires compliance with the health and regulatory requirements applicable to each product.
In IzzoMed We provide regulatory affairs services for companies and manufacturers seeking register medical devices in Peru, from the initial product evaluation and documentation to the management of the corresponding procedure before DIGEMID.
Our service registration of medical devices in Peru It includes the evaluation of applicable requirements, document review, and management of the corresponding procedure.
We work with national and international manufacturers who are looking to introduce their medical devices into the Peruvian market.
Services for the registration of medical devices in Peru
We support each project according to the characteristics of the device, its documentation and the needs of the manufacturer or company responsible for its entry into the Peruvian market.
Regulatory assessment
We analyze the characteristics of the medical device and the available documentation to identify applicable regulatory requirements and determine the appropriate path for its registration.
Documentation review
We review the available technical and administrative documentation to identify any gaps, inconsistencies, or documents that need to be supplemented before starting the procedure.
Regulatory strategy
We define a strategy according to the product characteristics and applicable requirements, seeking to avoid unnecessary steps and facilitate the development of the regulatory procedure.
Preparation and management of the file
We support the preparation of the necessary documentation and the management of the corresponding file before the health authority.
Local representation
We provide regulatory representation and support in Peru for international manufacturers who require a local partner to manage their regulatory activities.
Procedure monitoring
We support the regulatory process and monitor the actions and requirements related to the corresponding procedure.
What medical devices can we manage?
We work with different types of medical devices subject to health regulations in Peru.
Among the projects we can evaluate are:
Medical equipment and devices.
Devices used for diagnosis and treatment.
Electromedical equipment.
Sterile medical devices.
Single-use medical devices.
Devices used in surgical procedures.
Specialized medical products and technologies.
Each device requires an individual evaluation., since the requirements may vary according to their characteristics, intended purpose, documentation and marketing conditions.
Registration of medical devices with DIGEMID
The regulatory procedure depends on the particular characteristics of each device and the requirements established by the Peruvian health authority.
Before starting a procedure, we recommend performing a regulatory assessment of the product to identify available documentation, applicable requirements, and potential gaps that need to be addressed.
This analysis allows for the establishment of an appropriate strategy and the preparation of the project before submitting the corresponding documentation.
Medical devices from international manufacturers
For a foreign manufacturer, entering the Peruvian market involves understanding local requirements and having a structure that allows for the proper management of the product in the country.
In IzzoMed We work with international manufacturers who are looking to introduce their medical devices in Peru.
We can participate from the Initial product assessment and document review including local representation, regulatory management and coordination of services related to its entry and marketing.
Our goal is to facilitate the development of the project and provide the manufacturer with a local support point for their regulatory activities.
Our process
We evaluate
We analyzed the device, its manufacturer, intended purpose, and available documentation.
We identified
We determine the regulatory requirements and aspects that must be addressed before starting the procedure.
We plan
We defined the strategy and the steps necessary to develop the project.
We manage
We assist in the preparation and management of the corresponding regulatory procedure.
We accompany
We provide support during the process and, where appropriate, after registration is obtained.
More than a health registration
The entry of a medical device into the Peruvian market does not end with the management of the regulatory procedure.
Depending on the project's needs, we can complement the regulatory service with solutions related to import, storage, distribution and marketing.
This allows manufacturers and companies to comprehensively assess the needs of their project before entering the Peruvian market.
Frequently asked questions about medical devices in Peru
What is a medical device?
A medical device is a product intended to be used for medical purposes, such as diagnosis, prevention, monitoring, treatment or relief of diseases or injuries, according to its intended purpose.
Do all medical devices require health registration in Peru?
Regulatory requirements depend on the product's characteristics and classification, as well as applicable health regulations. Therefore, we recommend conducting a preliminary assessment before initiating the procedure.
Can you help me register a medical device with DIGEMID?
Yes. IzzoMed provides management and regulatory support services for medical device-related projects, including assessment, document review, preparation and management of the corresponding procedure.
Do you work with foreign manufacturers?
Yes. We work with international manufacturers seeking to introduce their medical devices to the Peruvian market and who require regulatory support and local representation.
Can you evaluate my device before starting the registration?
Yes. An initial regulatory assessment allows for a review of the product's characteristics and available documentation to identify applicable requirements before initiating the procedure.
Can they also help with importing and distribution?
Yes. Depending on the project's needs, regulatory services can be complemented with solutions related to import, storage, and distribution.
Do you want to register your medical device in Peru?
If you are evaluating the registration of medical devices in Peru, We can review the product features and available documentation beforehand.