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.
Other South American Countries: Argentina, Chile, Colombia, Ecuador, Peru, Uruguay, Venezuela
Last Update January 2023
