A Registration Authorization (Registro Sanitario) is a document emitted by Peruvian National Authorities after the evaluation of the technical files of your products. Registration is required by Regulatory Authorities and it allows the bearer to import, market and distribute medical devices through national territory.
The registration has a validity period of five years.
Our service includes:
- Preparing and submitting your registration dossier for Pharmaceutical Products (drugs, herbal medicinal products, sugar substitutes, biologics, galenical, diet and nutritional products) and Medical Devices.
- Preparing and submitting your registration applications through VUCE (Ventanilla Única de Comercio Exterior).
- Reviewing and adapting your proposed labeling materials in spanish.
- Tracking of device license applications.
- Renewal of pharmaceutical package inserts, product brochures, labels and instructions for use.
- Technical translation from English and Portuguese to Spanish.
- Elaborating responses to notifications, observations and warning letters.