ANVISA Notification & Registration (Cadastro & Registro)

ANVISA uses different pre-market routes according to risk. Class I and II devices generally follow notification, while Class III and IV devices require registration and technical review. The submission must be consistent across the application form, legal manufacturer, Brazilian holder, intended use, models, technical name, classification, labeling and supporting evidence.

Prepare Your ANVISA Submission

When This Support Is Needed

Launching a Class I, II, III or IV medical device in Brazil

Transferring or restructuring a product portfolio under a Brazilian registration holder (BRH)

Adding new models, commercial configurations, or family members to an existing authorization

Moving from an older Brazilian authorization structure to the current RDC 751/2022 regulatory framework

What We Challenge Before Submission

Is the selected petition subject code correct for the product and intended change?

Do the model list and commercial configurations match the technical dossier exactly?

Does the Brazilian holder have the correct corporate operating authorization (AFE) scope for the activity?

Is the dossier complete enough to survive an in-depth technical review or subsequent compliance audit?

Are there contradictions between the Portuguese IFU, application form, and underlying performance evidence?

Our Pre-Market Support Includes

Notificação application strategy for Class I and II devices (RDC 751/2022)

Registration (Registro/Cadastro) strategy for Class III and IV devices

Application and petition planning in ANVISA's electronic Solicita system

Technical dossier compilation according to Brazilian structure

Legal manufacturer and Brazilian registration holder (BRH) data alignment

Grouping and family assessment for optimal dossier submission

Declarations, authorizations, and power-of-attorney documentation

Labeling, Portuguese IFU package review, and e-labelling strategy

Submission coordination and real-time petition status follow-up

ANVISA technical query and official exigência response formulation

Revalidation planning and renewal tracking for registered products

Application Quality Principle:

We build the application from the source evidence outward. Before submission, we cross-check the legal manufacturer, Brazilian holder, device name, technical name, models, intended use, risk class, certificates, dossier and label so ANVISA receives one coherent regulatory position.

File Your ANVISA Notification or Registration with Confidence

Our team prepares complete electronic dossiers in Solicita, tracks petition progress, and defends against ANVISA exigências.

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