Health, Safety and Environment (HSE) in Brazil
The Brazilian Health Regulatory Agency (Anvisa) implemented RDC 848/2024, updating the essential safety and performance requirements for medical devices. This new regulation replaces RDC 546/2021 and introduces key changes, particularly the inclusion of in vitro diagnostic (IVD) devices. By aligning Read More …
Brazil’s National Health Surveillance Agency (ANVISA), has announced an upcoming update to regulations concerning in vitro diagnostic devices (IVD). This move aims to modernize and enhance the regulatory framework to ensure the safety, efficacy, and quality of these crucial healthcare Read More …
Importing products for clinical or technological research in Brazil requires adherence to specific codes outlined by the Brazilian Health Regulatory Agency (Anvisa). These codes facilitate the process of obtaining approval for importation, ensuring compliance with regulatory standards. Here’s a comprehensive Read More …
The Brazilian Health Regulatory Agency (Anvisa) has recently introduced new subject codes for the streamlined evaluation of medicines, biological products, vaccines, and Active Pharmaceutical Ingredient (API) Dossier Suitability Letters. These codes facilitate the use of assessments conducted by equivalent foreign regulatory authorities, enhancing regulatory confidence and Read More …
The Brazilian Health Regulatory Agency, Anvisa, has taken a significant step toward streamlining the medical device registration process. In a recent move, Anvisa announced that it will now consider analyses conducted by equivalent foreign regulatory authorities when evaluating petitions for device Read More …
Brazil’s National Health Regulatory Agency (Anvisa) has announced an extension of the validity period for Good Manufacturing Practice (GMP) certificates. Medical device manufacturers participating in the Medical Device Single Audit Program (MDSAP) will now see the validity of their certificates Read More …
On March 6th, the Brazilian Health Regulatory Agency (Anvisa) approved a new resolution addressing the essential safety and performance requirements for medical devices and in vitro diagnostic devices (IVD). This significant development comes as a response to the evolving landscape Read More …
If you are a diabetic or have a chronic respiratory condition, you might be tempted by the idea of using a smartwatch to monitor your blood sugar or oxygen levels. After all, these devices are convenient, discreet, and easy to Read More …