Mexico’s Cofepris has Issued New Guidelines for Changes to Medical Device Registrations
In August 2023, Mexican regulators have updated guidance on rules for modifications to medical device registrations that could streamline COFEPRIS reviews.
Brazil’s Anvisa Organization of the Common Technical Document (CTD) Copy
Organization of the Common Technical Document (CTD) outlined by Brazil’s Anvisa Regulations for format of Pharmaceutical dossiers.
UPDATES ON FDA COSMETIC REGISTRATION IN USA UNDER MOCRA 2022
On August 7, 2023, FDA issued a draft guidance that explains the requirements of facilities registration and products listing with the FDA under the Modernization of Cosmetic Regulations Act 2022 (MOCRA).
Brazil’s Anvisa Organization of the Common Technical Document (CTD)
Organization of the Common Technical Document (CTD) outlined by Brazil’s Anvisa Regulations for format of Pharmaceutical dossiers.
How are Heath Products Regulated with Brazil’s ANVISA?
Product registration at Anvisa is the last stage of regularization and is where the product will be tested to ensure product safety and efficiency.
Import Declaration in Brazil : How to Prepare for your import
The import declaration is a fundamental step in importing goods into Brazil. Without it, customs clearance does not take place, and the goods transported do not reach the hands of the importer.