Medical Device Registration and Approval in Brazil
General country-specific regulatory information is provided on this page for medical device registration and approval in Brazil.
Last updated on May 30th, 2022.
Medical Device Regulations and Classification in Brazil
REGULATORY AUTHORITY: Medical devices are regulated by The Brazilian Health Regulatory Agency (ANVISA)
Medical Devices: Medical Devices are classified into four classes based on risk (Class I-IV).
IVD Devices: IVD Devices are classified into four classes based on risk (Class I-IV)
Class I & II: within 30 days
Class III & IV: within 8-15 months
INMETRO certification is a mandatory requirement for the following devices: electric device, hypodermic needle, sterile single-use syringes, breast implants, surgical and non-surgical rubber gloves, condoms.
ANATEL certification is required for devices with certain functionalities such as Bluetooth, Wi-Fi, Radio Frequency (RF), etc.
LOCAL FEES (New application):
Class I/II: USD 190
Class III: USD 890
Class IV: USD 925
LOCAL FEES (Manufacturer):
The foreign manufacturing facility must be certified by Brazilian Good Manufacturing Practices (BPF) certification.
BPF certification (non-Mercosur countries): USD 24000
BPF certification (Domestic/Mercosur countries): USD 5400
The GMP certificate (BPF) will be valid for 2 years (class III&IV only).
The registration certificate will be valid for 10 years (class III&IV only).
LICENSE TRANSFER: According to Resolution RDC No.102/2016, transfer of ownership will be considered as new registration process.
AUTHORIZED REPRESENTATIVE/LICENSE HOLDER: Foreign manufacturer must appoint a local importer to become their authorized representative.
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