New Distributor: Who Holds Your Anvisa Cosmetic Registration?
Changing your Brazilian distributor? Xenia explains when an Anvisa cosmetic registration can move, the 180-day filing window and what to agree before signing.
Tag
Product certification in Brazil
INMETRO for equipment, ANVISA for cosmetics and health products, Anatel for anything wireless. Three regulators, one local representative, Portuguese files.
Brazil splits certification between three authorities, and the first job on any project is deciding which of them a product answers to. INMETRO is the technical regulator for equipment, machinery and electrical products, and its certification is what allows the goods to be sold at all. ANVISA is the health surveillance agency for cosmetics, medical devices and supplements. Anatel covers any product with a wireless or telecommunications function, industrial equipment included, and CE or FCC marks do not remove the requirement to test in Brazilian laboratories. A wireless pressure sensor is assessed twice, as a measuring device and as a radio.
All three share one prerequisite: a local representative and documentation in Portuguese. INMETRO certification takes three to six months including the audit, needs that representative, and produces a certificate valid for two to three years, with maintenance that suspends the certificate if it lapses. ANVISA runs a notification measured in days for most cosmetics and a registration measured in months for a listed group. Asking INMETRO to certify a product that belongs to ANVISA is the most common first wrong turn, and it costs weeks.
Explosion-proof equipment for Brazil’s oil, gas and mining sectors goes through INMETRO Portarias, where IECEx certification gives presumption of conformity and ATEX does not, so an ATEX file needs a gap assessment first. The articles below cover INMETRO for German and Italian makers, ANVISA for cosmetics, Anatel for industrial equipment, Ex equipment and the wireless sensor. Send the product and we will name the regulator before anything is filed.
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Articles tagged Brazil
Anvisa Post-Market Surveillance: Handling a Cosmetic Complaint
What Anvisa's RDC 894/2024 asks of a cosmetic brand when a consumer in Brazil complains: who answers, the 20-day and 15-day deadlines, records and recalls.
INMETRO and ANVISA: Two Brazilian Routes Compared
INMETRO handles equipment and machinery, ANVISA handles cosmetics and health products. Different stages, different validity, and one shared prerequisite.
INMETRO Certification for German Equipment Makers
The five-step INMETRO route into Brazil for industrial, electrical and laboratory equipment, with realistic timelines and what it buys you in tenders.
Anatel Certification for Industrial Equipment in Brazil
Which industrial products need Anatel approval, why CE and FCC do not substitute for it, and the four mistakes that turn into customs delays.
Certifying a Wireless Pressure Sensor in Brazil
A device that is both a measuring instrument and a radio transmitter faces two sets of requirements. The four steps, and the three that trip people up.
Certifying Explosion-Proof Equipment for Brazil
INMETRO certification for Ex equipment: the three product categories, the document list, and when IECEx gives presumption of conformity and ATEX does not.
ANVISA Cosmetic Certification in Brazil: A Route Map
What ANVISA requires before a cosmetic can be sold in Brazil: the four document sets, the three tests, Portuguese labelling rules and the ingredient limits.
Frequently asked questions
Do we need a company in Brazil to get certified?
You need a local representative, which can be an importer or a service provider, for INMETRO and ANVISA alike, and the documentation has to be in Portuguese. The representative holds obligations after the certificate issues, so choose one you expect to keep.
Does our CE or ATEX certificate count in Brazil?
Not on its own. Anatel and INMETRO require testing in Brazilian laboratories, and for Ex equipment only IECEx certification gives presumption of conformity; EN and ATEX standards and older IEC editions go through a gap assessment. Existing reports shorten the work without replacing it.
Tell us what you are exporting
Send the product name, HS code and technical data. You get back the applicable route, the document list and a timeline, before any commitment.
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