NKB Regovanta - Global Regulatory, Quality & Market Access Consulting
HomeServicesBrazilProduct Classification
Back to Brazil Overview
RDC 751/2022 & RDC 830/2023

ANVISA Regulatory Strategy & Product Classification

Correct classification is the foundation of the Brazilian submission. Under RDC 751/2022, medical devices are classified from Class I to IV according to risk. The classification determines whether the product follows notification or registration, the level of evidence expected, BGMP implications and the way changes will be controlled after market entry.

Define Your ANVISA Regulatory Pathway

When This Support Is Needed

A new medical device or IVD is being introduced in the Brazilian market
The intended use or clinical claims differ from an existing US/EU global registration
The manufacturer is uncertain whether the product is a medical device, accessory, SaMD or IVD
A product family needs to be grouped appropriately for Brazilian regularization
An existing classification may be affected by a design, software or intended-use change

What We Challenge Before Submission

Does the intended use support the proposed risk class?
Does the Brazilian technical name align with the device actually being marketed?
Are all models legitimately grouped under the same family or notification/registration?
Will a planned claim or feature move the device into a higher-risk rule?
Does the current global evidence actually support the Brazilian configuration?

Our Support Includes

Product qualification and Brazilian regulatory status assessment
Intended purpose, clinical indications and marketing claims review
Class I, II, III, and IV risk classification under RDC 751/2022
IVD risk classification under RDC 830/2023
Accessory, system and family grouping considerations
Brazilian technical-name (nome técnico) and grouping strategy
Notificação versus Cadastro / Registro pathway assessment
Initial BGMP / CBPF applicability and timeline assessment
Regulatory evidence roadmap and technical dossier gap analysis

ANVISA Classification Principle:

We do not treat classification as a checkbox. We trace the classification decision into the entire Brazilian pathway: registration regime, dossier depth, manufacturing certification (CBPF), labeling, post-market controls and change obligations.

Establish Your ANVISA Risk Classification and Pathway

Our Brazilian regulatory specialists classify your devices under RDC 751/2022, map nome técnico codes, and determine Notificação vs Registro.

Book a Consultation