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 …
Anvisa cancels 47 hair pomades and bans immediate marketing
Products were canceled for not meeting the criteria established for this category of cosmetics. On Monday (02/24), the Brazilian Health Regulatory Agency (Anvisa) ordered the regularization of 47 hair pomades used for fixing and styling hair to be canceled (Resolution-RE 681/2025). The …
E-Notivisa will now register notifications of adverse events and technical problems related to food
The new system module will be launched during a webinar on 9/23, at 10 am. Join in! Next Monday, September 23, at 10 am, Anvisa will hold an online seminar (webinar) to present the new e-Notivisa module. From now on, the …
How to Import Dental Products
The import of dental products is a growing market, especially for high-demand materials such as zirconia blocks and lithium disilicate. These products, essential for state-of-the-art dental procedures, require a specific import process that involves strict regulations. In this article, we will explore how …
Anvisa extends the period of validity of the Certificate of Good Manufacturing Practices to four years.
This measure is valid for companies participating in the MDSAP program. The Brazilian Health Surveillance Agency (Anvisa) decided to extend the validity period of the Certificate of Good Manufacturing Practices (CBPF) for manufacturers of medical devices that participate in the Medical Device …
Anatel authorizes the experimental phase of the provision of mobile telephone services via satellite.
The Brazilian Telecommunications Agency (Anatel) used a mechanism called Regulatory Sandbox, an approach that makes regulations more flexible for telecommunications projects considered to be of great relevance to the country. Anatel’s Board of Directors decided, during a virtual meeting held on Thursday …
https://www.licempre.com.br/anvisa-na-46a-reuniao-do-ich-avancos-em-produtos-farmaceuticos/
The Brazilian Health Regulatory Agency (Anvisa) will be present at the 46th meeting of the International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH). The event took place in Vancouver, Canada, from June 9th to 14th. With 17 …
Low-impact pesticides to control diseases and pests are new alternatives for farmers.
Published on December 7th, in the Diário Oficial da União [Federal Official Gazette], Act No. 57 of the Department of Plant Health and Agricultural Inputs of the Secretary for Agricultural Defense, presents the registration of 45 new agricultural pesticides formulated, which will …
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