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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 January 24th, 2023.
Medical Device Regulations and Classification in Brazil
REGULATORY AUTHORITY:
The Brazilian Health Regulatory Agency (ANVISA)
CLASSIFICATION SYSTEM:
Medical Devices/IVDs: I/II/III/IV.
TIMEFRAME:
Class I & II: within 30 days
Class III&IV: within 8-15 months
SPECIAL REQUIREMENT:
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.
On-site audit
BPF certification (non-Mercosur countries): USD 24000
BPF certification (Domestic/Mercosur countries): USD 5400
LICENSE VALIDITY:
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:
Foreign manufacturer must appoint a local importer to become their authorized representative.
ADDITIONAL INFORMATION:
Resolution No 185/2001 will soon be replaced by Resolution RDC No.721 that was issued in September 2022 and will be fully enforced by March 2023.
For detailed device-specific compliance information for each market, including Brazil, to expedite the preparation of your medical device or IVD registration application.
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