Brazil’s ANVISA Extends the Validity Period of the Brazilian GMP Certificate
ANVISA has extended the validity period of the Good Manufacturing Practices Certificate to four years.
Blog – Understanding the Registration Process of Cosmetics with Brazil’s Anvisa
Before starting the registration process in Brazil, it is essential that the company complies with all regulatory requirements. This involves obtaining the Operating License/Authorization from the local health surveillance agency and the AFE/AE from Anvisa.
Exploring the Diversity of Medical Devices for Health Promotion in Brazil
Overview: Brazil stands out as the main market for medical devices in Latin America, with an established, albeit complex, regulatory system. Medical products in the country are regulated by the National Health Surveillance Agency (ANVISA). Against this backdrop, we explore the main types of medical devices and their specific applications within the Brazilian context. Introduction: […]
Health Product Labelling Requirements for Imported Products into Brazil
The import of Health products into Brazil is subject to various regulations, with proper labelling being a crucial part of this procedure. These regulations cover the current standards for labelling imported products, outlining the responsibilities of importers and the essential elements that must be included on labels.
Brazil’s Anvisa Updates the Labeling of Cosmetic Products – 2024
The Labeling of Cosmetics in Brazil’s regulations will start including INCI requirements in 2024.
Brazil’s Anvisa’s Medical Devices for In Vitro Diagnosis Regulation (RDC 830/2023) comes into force in June 2024
Anvisa’s RDC 830/2023 Regulating Medical Devices for In Vitro Diagnosis comes into force in June 2024
Ensuring the Thermal Integrity of Pharmaceutical Products in Brazil
Brazil’s Anvisa, legislation provides guidance on the qualification of the transportation of biological products in bulk in their primary and finished packaging.
Consultations Meetings with Anvisa – Health Products
Scheduling your Meeting Consultations with Anvisa: Brazilian System-Parlatory
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.
Brazil’s Anvisa update to Medical Device Regulation RDC 751/2022: The Importance of Grouping Devices
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.