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How Classification Works

ANVISA classifies medical devices into four classes — Class I through Class IV — based on the potential risk the device poses to patients and users. This risk-based approach is aligned with the IMDRF and MERCOSUL GMC Res. 40/2000 framework.

The four-class system​

ClassRisk levelRegulatory pathwayExamples
Class ILowNotificaçãoTongue depressors, non-sterile bandages, examination gloves
Class IIMedium-lowCadastroSyringes, manual wheelchairs, non-implantable orthopaedic devices
Class IIIMedium-highRegistroPowered wheelchairs, diagnostic imaging equipment, anaesthesia machines
Class IVHighRegistro (strictest)Pacemakers, heart valves, implantable defibrillators, drug-eluting stents

Classification rules​

Classification follows rules applied to the device's intended purpose, duration of contact (transient/short-term/long-term), degree of invasiveness, and active/non-active nature. Rules are defined in RDC 751/2022 Annex I and the ANVISA classification catalogue.

BR-unique

Brazil's classification rules are closely aligned with MERCOSUL GMC Res. 40/2000 and share significant overlap with EU MDR (2017/745) classification rules. An EU MDR classification analysis is a useful starting point for a Brazilian classification exercise.

Using the ANVISA classification catalogue​

  1. Search the catalogue by device type or intended purpose;
  2. If found, apply the assigned class;
  3. If not found, apply the classification rules in RDC 751/2022 Annex I; and
  4. If still uncertain, submit a consulta de enquadramento to ANVISA.

Official resources​