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
Registration holder for Medical Devices Imported from Mexico
Registration holder for Medical Devices Imported from Mexico.
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.
Mexico’s Cofepris medical Device and IVD Registration and Approval in Mexico
GRP Mexico can help you obtain COFEPRIS medical device registration and approval to sell your product on the Mexican market.
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.
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.
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.