Understand the Requirements of IN 242/2023 and How to Ensure Regulatory Compliance

ANVISA Update: New labeling rules for hygiene products, cosmetics and perfumes.

QR Group Explains ANVISA’s New Labeling Rules: How to Adapt Your Products Normative Instruction IN No. 242/2023, published by ANVISA, brought significant changes to the labeling of personal care products, cosmetics, perfumes, and disposables. Now, whenever there is a formula modification, the “NEW FORMULA” or “NEW COMPOSITION” statement must be included in the label. If […]

QR Group Explains the Classification of Odor Neutralizers: Cosmetics or Sanitizers? Enviar feedback Resultados de tradução disponíveis

Odor neutralizers classified as cosmetics or sanitizers according to ANVISA.

Understand how ANVISA’s regulation impacts the classification of odor neutralizers and QR Group’s role in adapting to standards. The classification of odor neutralizers has raised doubts in the market, especially about whether they should be treated as cosmetics or sanitizers. RDC Resolution No. 752, of 2022, and RDC No. 59, of 2010, provide the guidelines […]

How Generative Artificial Intelligence is Transforming the Brazilian Health Sector

Implementation of generative AI in the health sector, in accordance with ANVISA regulations.

Discover how the adoption of generative AI is driving productivity and reinvention for healthcare companies in Brazil. Generative Artificial Intelligence (AI) is becoming a crucial tool for the healthcare sector in Brazil, bringing productivity and efficiency gains to companies. According to the 28th edition of the Global CEO Survey, 58% of healthcare CEOs in Brazil […]

The Trends of the Health Sector in Brazil and the Impact of Technological Innovation

Executives analyzing innovation trends in health and regulation by ANVISA.

How Technological Innovation and Generative AI Are Transforming the Healthcare Market in Brazil The 28th Global CEO Survey revealed that business leaders are increasingly focused on reinventing their business models to generate value, ensure sustainability and drive innovation. In the healthcare sector in Brazil, this trend translates into the accelerated adoption of generative artificial intelligence, […]

Bonded Warehouse for Healthcare Products: How to Ensure Compliance and Efficiency with QR Group

Stock management in real time without warehouse deposit for medical devices.

Bonded Warehouse Management for Health Products in Brazil The storage of health products requires specialized infrastructure, strict control, and compliance with ANVISA and Federal Revenue standards. The bonded warehouse allows imported medical supplies to be stored in optimal conditions before being released for commercialization in Brazil. QR Group, a specialist in health product regulation, offers […]

Back-Office Structure for Medical Device Distribution in Brazil: How to Improve Efficiency and Compliance

Back-office structure for efficient distribution of medical devices in Brazil.

How Does a Back-Office Structure Optimize Medical Device Distribution? The distribution of medical devices in Brazil involves operational and regulatory challenges that require efficient management. A well-organized support structure simplifies administrative tasks, improves operational efficiency, and ensures compliance with ANVISA regulations, providing sustainable growth for companies in the sector. Order Processing: Reducing Errors and Ensuring […]

Management Systems Optimization: How QR Group Ensures Quality and Compliance

Training in Quality Management System for compliance with ANVISA and international standards.

The Importance of Implementing a Quality Management System In the healthcare industry, an efficient Quality Management System (QMS) is essential to ensure regulatory compliance, product safety, and operational efficiency. Companies that adopt and certify their QMS according to recognized standards, such as ISO 13485, have a competitive advantage and reduce the risk of non-compliance. QR […]

QR Group Explains the Role of the Brazilian Registration Holder in Medical Device Regulation

Medical device registration process with ANVISA.

How Foreign Manufacturers Can Market Medical Devices in Brazil For foreign medical device manufacturers to distribute their products in Brazil without having a licensed company in the country, it is necessary to appoint a Brazilian Registration Holder (BRH). This regulatory representative acts as the link between the company and the National Health Surveillance Agency (ANVISA), […]

Medical Device and In Vitro Diagnostic Registration: The Complete Guide for Foreign Manufacturers in Brazil

Registration of medical devices with ANVISA with consultancy from QR Group.

Understand how ANVISA regulations affect the registration of medical devices and in vitro diagnostics and how QR Group can help with compliance. Brazil, the largest medical device market in Latin America, offers great growth opportunities for international manufacturers. However, the regulatory process for medical devices and in vitro diagnostic products requires detailed attention to ANVISA […]