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). Starting April 1, 2024, the validity of the GMP Certificate for medical device manufacturers, granted through the Medical Devices Single Audit Program (MDSAP), was extended from two to four years.

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. 

In normative instruction number 290 which was released on April 4, 2024, a new optimized pathway was published for class III and class IV medical devices. This aims to recognize selected overseas approvals. Specifically for devices that have been authorized by at least one of the following AREEs (Equivalent Foreign Regulatory Authority):
– Australia: TGA, Australian Register of Therapeutic Goods
– Canada: Health Canada, Medical Device Licence
– USA: FDA, 510(k) Clearance, Premarket Approval, or 513(f)(2) “De Novo”
– Japan: Ministry of Health, Labour and Welfare, Pre-market approval

Other South American Countries: Argentina, Chile, Colombia, Ecuador, Peru, Uruguay, Venezuela

Last Update September 2024