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IVD Device Registration

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Imported in vitro diagnostic medical devices are required to be registered with DIGEMID before they are marketed in our country. This category includes diagnostic reagents used for clinical diagnosis in hematology, pathology, immunology, and nuclear medicine.

Registrations must be renewed every 5 years.

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Regulatory Strategy

We will outline the optimal regulatory strategy for your products, according to their risk classification.

Assessment

Evaluating technical and scientific documentation issued by the manufacturer.

Application

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

Follow-up

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

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Perú Registration Holder

Pharma Consulting can act as your in-country representative.

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Medical Devices

Class I, II, III, and IV medical devices. Biomedical equipment, and electromedical systems.

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Dietary Supplements

Vitamins, enzymes, amino acids, herbal extracts, powders, and sweeteners.

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In Vitro Diagnostic Medical Devices

IVD products, biochemistry analyzers, and reagents.

Get in Touch

    Contact us on WhatsApp at 997556699 or by email at [email protected] and quote our in vitro diagnostic medical device registration services in Peru.
    Over 15 years of experience will ensure you get the best guidance.