Update January 1, 2023
RDC No. 751/2022
RDC No. 185/2001
RDC No. 36/2015
RDC No. 497/2021
Medical device guidance
Updated rules announcement
ANVISA classifies medical devices, including IVDs, into the following classes:
Class I - Low risk. Examples include simple surgical instruments and tongue depressors.
Class III - High risk. Examples include dialyzers and orthopedic implants.
Class II - Medium risk. Examples include infusion pumps and powered wheelchairs.
Class IV - Highest risk. Examples include coronary stents.
Medical device manufacturers without a physical location in Brazil must appoint a Brazil Registration Holder (BRH) who will submit your registration application and maintain control of your device registration and Brazil Good Manufacturing Practice (B-GMP) certification. Note that registration transfers will require the cooperation of the previous BRH.
Note that while B-GMP is a separate standard, it is similar to ISO 13485 and the FDA's QSR and most devices which comply with either of these standards will comply with B-GMP.
Application forms must be completed in Portuguese, all other forms may be completed in Portuguese, Spanish, or English.
Class I and Class II devices
Registrations for Class I and Class II devices do not expire and share similar requirements.
Brazil-GMP is required, but ANVISA will not audit compliance.
An abbreviated registration process (Cadestro) is followed, which requires a technical dossier that includes legal documents and labeling information.
Class III and Class IV devices
Class III and Class IV device registrations expire after 10 years.
A Brazil-GMP audit is required.
An ordinary registration process (Registro) is followed, which requires general device information, certificate of free sale, GMP, instruction manual and labeling, clinical data, and clinical study report (where applicable).
Some medical devices will require certification from The National Institute of Metrology, Standardization, and Industrial Quality (INMETRO) in order to obtain ANVISA certification. Devices that require INMETRO certification are primarily electro-medical devices subject to IEC 60601 and renewals are required every 5 years.
New regulations coming into force March 1, 2023
The new regulations due to come into force on March 1, 2023 introduce some significant changes, including:
New classification rules for new technology, including Software as a Medical Device (SaMD) and nanomaterials.
Adoption of the IMDRF Table of Contents structure for technical dossiers.
Multiple rules advancing the consolidation and digitization of information.
ANVISA post-market responsibilities are shared by the manufacturer and the Brazil Registration Holder. Requirements include post-market monitoring, reporting, and field safety corrective actions.
UDI labeling requirements in Brazil come into effect as follows:
Class IV - June, 2024
Class III - January, 2025
Class II - January, 2026
Class I - January, 2028