Overview
Brazil has a mandatory certification system regulated by INMETRO (National Institute of Metrology, Standardization and Industrial Quality) that applies to many electrical and electronic products. Brazilian regulations require certification prior to import or sale, with different conformity assessment procedures depending on product risk level. Most regulated products require testing by accredited laboratories and certification through an approved Brazilian certification body (OCP).
Required Certifications
INMETRO
Safety & EMC
INMETRO certification is required for a wide range of product categories in Brazil, with requirements based on national standards. The certification process typically involves selection of a local certification body (OCP), type testing at accredited laboratories, factory inspection, certification issuance, and ongoing surveillance. Products must bear the INMETRO mark, and certification requires periodic factory assessments and product re-evaluation. Foreign manufacturers must appoint a local representative in Brazil who assumes legal responsibility for product compliance.
Mandatory
Yes
Follow-up Inspections
Required
Validity Period
3-4 years
Mark Required
Yes
Local Representative
Required
ANATEL
Telecommunications
The National Telecommunications Agency (ANATEL) certification is required for telecommunications and radio equipment in Brazil. Products that connect to the public network or use radio frequency must be tested and certified by designated laboratories. The certification process involves laboratory testing, documentation review, and homologation (formal approval). Once certified, products must display the ANATEL identification seal containing a unique homologation number.
Mandatory
Yes
Follow-up Inspections
Not Required
Validity Period
2 years
Mark Required
Yes
Local Representative
Required
ANVISA
Medical Devices
The National Health Surveillance Agency (ANVISA) certification is required for medical devices and healthcare products in Brazil. The registration process varies by risk classification, with higher-risk devices requiring more extensive documentation and testing. Foreign manufacturers must appoint a Brazilian Registration Holder (BRH) who takes legal responsibility for the products in the Brazilian market. ANVISA registration must be renewed every five years, and any changes to registered products require regulatory notification or approval.
Mandatory
Yes
Follow-up Inspections
Required
Validity Period
5 years
Mark Required
No
Local Representative
Required
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