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 …
Sanitary Registration of Health Products
The sanitary registration of a health product is the authorization issued by ANVISA (National Health Surveillance Agency) that allows the manufacture, import, marketing and use of products intended for the health area in Brazil. The registration certifies that the product has been …
Cosmetics Migration to the Solicita System: What You Need to Know and How to Regularize Your Products in Time!
Anvisa has announced a significant change for the cosmetics and personal care products sector. From March 3, 2025, the regularization of new products and any changes to products already registered will have to be performed exclusively through the Solicita application system. Companies …