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 RDC No. 185 was replaced by Resolution RDC No. 752, issued in September 2022 and enforced on March 2023.
Other South American Countries: Argentina, Chile, Colombia, Ecuador, Peru, Uruguay, Venezuela
Last Update January 2023
