Regulatory Authority
Agência Nacional de Vigilância Sanitária (ANVISA)
Classification
I, II, III, IV
Quality system
Compliance with BGMP (Brazilian Good Manufacturing Practices) is required for the marketing of Medical Devices or IVDs. The Brazilian requirements regarding the Quality Management System (QMS) for Medical Devices are defined by the Regulation RDC 665/2022.
Brazil is among the participants in the MDSAP Program (Medical Device Single Audit Program), along with the United States, Canada, Australia and Japan.
Foreign manufacturers who intend to market their Medical Devices in Brazil must appoint a Brazilian Registration Holder (BRH), i.e. an Authorized Local Representative responsible for submitting to ANVISA the necessary documents for the registration procedure.
Class I Medical Devices and IVDs (starting May 2, 2019) and class II Medical Devices (starting September 18, 2020) are no longer subjected to Cadastro and instead follow a simplified notification procedure, in accordance with RDC 270 / 2019 and RDC No. 423/2020. The applications must still be submitted to ANVISA, but are not subjected to technical review.
Class III and IV Medical Device manufacturers must demonstrate compliance with BGMP requirements in order to be able to follow the “Registro” registration process with ANVISA.
Applicant
Authorized Local Representative (BRH).
Timeframe and fees
Notification path: the notification number will be issued within 30 days.
“Registro” registration process: between 8 and 15 months.
Taxes are required for both types of registration.
Validity
The Notification (class I and class II) has unlimited validity.
The Registro registration is valid for 5 years.
Labelling and documentation language
The documentation and the labelling must be provided in Portuguese.
Useful information
Devices composed of similar materials and/or with the same intended use can be grouped together within a single registration.
Active Medical Devices compliant with IEC 60601-1 must be certified by an INMETRO accredited laboratory and must display the INMETRO mark. The INMETRO Certification is a pre-market requirement for some electroMedical Devices and non-active devices and is valid for 5 years.
