Services for operations in Brazil.

Medical device registration and notification

Support for medical device market access in Brazil, based on intended use, classification and technical documentation.

TECNOVISA

A scope tailored to your operation.

We consider the product category, business activities, establishment and documentation available for assessment.

The proposal identifies deliverables, responsibilities, dependencies and any third-party work or official fees.

Tecnovisa carries out the agreed regulatory work and follow-up according to the scope of the engagement.

Consulting for manufacturers, importers, distributors, warehouses and carriers of medical devices, according to the applicable requirements.

Evaluate registration hosting with clear responsibilities for the manufacturer, registration holder and commercial operation in Brazil.

Review the official request, the process history and the available evidence to define a consistent response strategy.

TECNOVISA

Discuss your company’s regulatory needs and the scope of a suitable engagement.