Overview of Medical Device Anvisa Regulations in Brazil
The most important regulation for Medical Devices in Brazil is RDC 751/2022, which provides for the risk classification, notification and registration regimes, labeling requirements, and instructions for use of medical devices.
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.
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.
Brazil’s ANVISA Introduces New Rules on Drug labeling with RDC 768/22
As of July, the new regulatory framework for drug labeling, the RDC 768/22, from the National Health Surveillance Agency (Anvisa), comes into effect.
Anvisa: How can I get a CADIFA anyways?
Blog explains the process and How can CADIFA’s are issued and approved by Brazil’s Anvisa. A CADIFA is the Term used by Anvisa to describe an approved DMF for an API in Brazil.
Brazil’s Anvisa Classification of Personal Hygiene Products, Cosmetics & Perfumes
Understand Brazil’s Anvisa criteria for the classification of personal hygiene products, cosmetics, and perfumes.
CADIFA – Letter of Suitability of the Active Pharmaceutical Ingredient
CADIFA (letter of suitability of the active pharmaceutical ingredient) is the administrative instrument that attests the compliance of a DIFA (active pharmaceutical ingredient dossier) with the requirements of Resolution – RDC nº 359/2020.
Transfer of Ownership of Registrations at ANVISA
Understanding the Transfer of Ownership of Registrations at ANVISA. The Resolution No 233/2018, began to allow the transfer of registration ownership of products subject to Health Surveillance through commercial operations.
Brazil’s Anvisa & Medical Device Single Audit Program (MDSAP)
Good Manufacturing Practices (GMPs) x Medical Device Single Audit Program (MDSAP)
Brazil’s Anvisa Medical Device Single Audit Program
GRP Blog explains the Registration process of Medical devices and IND in Brazil with The Brazilian Health Regulatory Agency (ANVISA). New issued regulation RDC No. 751/2022 on Sept. 21, 2022 have updated the registration process.