Anvisa’s new rules for sanitizers: modernization and more safety for consumers
On August 20, 2025, the Brazilian Health Regulatory Agency (Anvisa) published two rules that significantly update the regulatory framework for sanitizing products in Brazil: Collegiate Board Resolution (RDC) 989/2025, and Normative Instruction (IN) 394/2025. These rules replace the old RDC 59/2010, …
INMETRO registration: speed and expertise for your product to reach the market
Companies that work with automotive components—such as tires, helmets, motorcycle and bicycle parts—know that INMETRO certification and registration are mandatory for legal commercialization in Brazil. However, most face a common scenario: bureaucracy, complex technical requirements, and extended deadlines. The good news? With …
Legal Representative in Brazil: What It Is, Who Needs One, and How Licempre Can Help Your Company
Foreign companies wishing to market products or operate in Brazil must comply with a series of regulatory requirements. One of the most important is the appointment of a Legal Representative, a key figure in ensuring compliance with Anvisa, Inmetro, the Federal Revenue …
Increased Inspections: How to Avoid Fines Due to Regulatory Failures with Anvisa and Inmetro
Regulatory inspections targeting companies that deal with regulated products are becoming increasingly strict. If you are a CEO, manager, or technical lead at a company that manufactures, imports, or distributes products subject to regulation, it is time to ask yourself: Is your …
UDI and SIUD: the new milestone of medical device traceability in Brazil
The National Health Surveillance Agency (ANVISA) is taking important steps towards the modernization of the regulation of medical devices in Brazil, with the implementation of the Unique Medical Device Identification (UDI) and the National UDI System (SIUD). These measures are part of …
Do I need to have a business office to Register or Notify the Cosmetic?
When planning to expand your cosmetics line to the Brazilian market, a frequent question among entrepreneurs is: “Do I need to have a physical office in Brazil to register or notify a cosmetic at ANVISA?” The answer is: not necessarily. Thanks to …
UDI Database: Anvisa Publishes Preliminary Guidelines Manual
The document highlights the features of the Unique Device Identification system that are already available. Anvisa has recently published the preliminary version of the operations manual for the UDI (Unique Device Identification) database—an international system designed to identify and track medical …
Product Registration Hosting – How International Companies Can Enter the Brazilian Market Quickly and Efficiently
Product Registration Hosting: A Solution for International Companies in Brazil Expanding into Brazil can be a strategic move, but regulatory bureaucracy often poses a major challenge. The good news? Product registration hosting allows international companies to operate in the country without the …
Phenol in Aesthetic Procedures: Anvisa Prohibits Use to Protect Health
The aesthetics market in Brazil is vibrant and handles millions of procedures every year. However, with the growing popularity of skin and rejuvenation treatments, there are also serious concerns about public health safety. One of the most important issues recently addressed by …
How to register an automotive product?
If you work in the auto parts sector or want to import and market automotive products in Brazil, you may have already asked yourself: how do you register an automotive product? The answer involves much more than just filling in forms. You …