Navigating the Frontier: The Global Regulatory Landscape for AI/ML-Enabled Medical Devices
The Brazilian Health Regulatory Agency (ANVISA) is intensifying enforcement against the dangerous practice of using cosmetics as injectables and reinforcing the strict adherence to Good Manufacturing Practices (GMP). Understand the regulatory implications for the cosmetics and medical device sectors in Brazil and the associated risks.
Global Techno vigilance: What changes with Anvisa’s adoption of IMDRF terminology
The Brazilian Health Regulatory Agency (ANVISA) is intensifying enforcement against the dangerous practice of using cosmetics as injectables and reinforcing the strict adherence to Good Manufacturing Practices (GMP). Understand the regulatory implications for the cosmetics and medical device sectors in Brazil and the associated risks.
Towards Sanitary Sovereignty: The Infliximab API and the Challenge of National Production
The Brazilian Health Regulatory Agency (ANVISA) is intensifying enforcement against the dangerous practice of using cosmetics as injectables and reinforcing the strict adherence to Good Manufacturing Practices (GMP). Understand the regulatory implications for the cosmetics and medical device sectors in Brazil and the associated risks.
Customs Revolution: ANVISA’s Phased Adherence to the New Import Process
This Blog addresses the intensified inspection efforts by the Brazilian Health Regulatory Agency (ANVISA) against the marketing of products without proper sanitary authorization. We analyze recent seizure cases involving Unregistered Hair Cosmetics (Botox and Straightening products) and Irregular Medicines/Herbal Supplements, highlighting how the absence of registration, notification, or proper listing exposes consumers to serious health risks and the industry to severe penalties.
The Shadow of Irregularity: Unregistered Medicines and Hair Cosmetics and the Hidden Risks
This Blog addresses the intensified inspection efforts by the Brazilian Health Regulatory Agency (ANVISA) against the marketing of products without proper sanitary authorization. We analyze recent seizure cases involving Unregistered Hair Cosmetics (Botox and Straightening products) and Irregular Medicines/Herbal Supplements, highlighting how the absence of registration, notification, or proper listing exposes consumers to serious health risks and the industry to severe penalties.
Global Convergence and Predictability: ANVISA Resets the Game for Medical Devices and the 2024-2025 Regulatory Agenda
ANVISA implements a new regulatory framework for Medical Devices (RDC 848/2024), seeking international alignment, and publishes the 2024-2025 Regulatory Agenda, signaling regulatory priorities for sectors like cosmetics and medicines. Understand the impact of regulatory predictability in Brazil.
ANVISA on High Alert: The Use of Injectable Cosmetics and the Strict Enforcement of Good Manufacturing Practices in Brazil
The Brazilian Health Regulatory Agency (ANVISA) is intensifying enforcement against the dangerous practice of using cosmetics as injectables and reinforcing the strict adherence to Good Manufacturing Practices (GMP). Understand the regulatory implications for the cosmetics and medical device sectors in Brazil and the associated risks.
Webinar Presents Preliminary Draft of the ICH Q3E Guideline on Impurities in Drug Products
The ICH Q3E Guideline (Impurities: Assessment and Control of Drug Substance and Drug Products) is a crucial directive aimed at harmonizing regulatory approaches for impurity control. This blog post details the main points of the preliminary draft presented in a recent webinar, discussing its impact and the need for preparation by companies, especially within the Brazilian regulatory context.
Toxicology and Safety in Cosmetics: Current Regulatory Requirements
The safety of cosmetics is a growing priority for both regulators and consumers. In Brazil, Anvisa establishes clear guidelines on toxicological evaluation and safety requirements for ingredients and finished products. This article explores what is currently required, with a focus on RDC 752/2022, addressing critical points for companies and professionals working in the sector.
Integration of the Health Surveillance Fee into the Single Foreign Trade Portal: Timetable and Impacts for Brazilian Trade
Anvisa (the National Health Surveillance Agency), in partnership with the Foreign Trade Secretariat (Secex) and the Federal Revenue Service, has announced the integration of the payment of the Health Surveillance Fee into the Single Foreign Trade Portal (Siscomex). This change is part of a move to centralize and digitize foreign trade processes, offering more agility, transparency and simplicity for importers and exporters dealing with products subject to health surveillance.
Gluten and Food Labeling: What You Need to Know
Gluten and Food Labeling: What You Need to Know
Discover That it is Possible to Import Dental Products.
Discover That it is Possible to Import Dental Products