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Medical Device Distribution in Perú

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We offer a special set of services intended for small and medium-sized businesses that wish to export and distribute pharmaceutical products, dietary supplements, medicines, medical devices, biomedical equipment, cosmetics, and any other healthcare product.

Registration (marketing authorization)

A marketing authorization (registro sanitario) is a document that enables its holder to manufacture, import, store, market, and distribute medical devices and health products within the national territory. It is emitted by Peruvian Health Authorities after a thorough evaluation of the product registration dossier.

Registration is required by law and is valid for five years. Set of services intended for small and medium-sized businesses that wish to export and distribute pharmaceutical products, dietary supplements, medicines, medical devices. biomedical equipment, cosmetics, and any other healthcare product.

What We Do

• Preparing and submitting your registration dossier for pharmaceutical products as diagnostic agents, radiopharmaceuticals, biologics, sugar substitutes, galenical products, and dietary supplements, medical devices, cosmetics, personal care products, articles for babies, and household cleaning products.

• Reviewing and adapting your proposed labeling materials in Spanish.

• Tracking of medical device license applications.

• Renewal of package inserts, product brochures, labels, and instructions for use.

• Elaborating responses to notifications, observations, and warning letters.

• Technical translation from English and Portuguese to Spanish.

Our service includes

Regulatory Strategy

We will outline the optimal regulatory strategy for your products, according to their intended use.

Assessment

Evaluating technical and scientific documentation issued by the manufacturer.

Application

Preparing a fully compliant registration dossier and submitting the registration application to DIGEMID.

Follow-up

Follow-up of applications. Replying to inquiries and amendment requirements by DIGEMID reviewers.

Specific Services

Medical Devices

Class I, II, III, and IV Medical Devices, electromedical equipment, and electromedical systems.

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IVD

In-Vitro Diagnostics, rapid tests, autotests. laboratory equipment, materials, and reagents.

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Dietary Supplements

Vitamins, aminoacids, enzymes, powders, herbal extracts, and sweeteners.

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Regulatory Affairs Consulting

If you need full Regulatory Affairs support, you can trust us.

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Get in Touch

    Contact us on WhatsApp at 997556699 or by email at [email protected] to learn more about medical device distribution in Peru.
    Over 15 years of experience will ensure you get the best guidance.