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.
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On August 7, 2023, FDA issued a draft guidance that explains the requirements of facilities registration and products listing with the FDA under the Modernization of Cosmetic Regulations Act 2022 (MOCRA).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.
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.
US FDA Releases Food Allergen Labeling
In May 2023, the U.S. Food and Drug Administration issued five more final orders completing the process of publishing different monographs as part of the over the counter (OTC) monograph reform under the Act CARES.