QR Group Explains the Importance of Integrated Logistics in Health: How to Guarantee Efficiency and Conformity
Understand how integrated logistics impacts the distribution of medical devices in Brazil and how QR Group ensures efficiency and regulatory compliance. Introduction Integrated logistics for healthcare products in Brazil is essential to ensure timely and safe delivery of medical equipment and supplies. With a vast territory and strict regulatory demands, it is essential to have […]
Bonded Warehouse for Healthcare Products: How to Ensure Compliance and Efficiency with QR Group
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
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
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
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
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 […]
ISO 13485 Certification for Medical Devices: Quality Assurance and Regulatory Compliance with QR Group
Understand how ISO 13485 certification, aligned with RDC 39/2013 and RDC 15/2014, is essential to ensure the quality and compliance of medical devices in Brazil. ISO 13485 certification is a fundamental requirement to ensure that medical devices meet the strict quality standards required by the market and Brazilian regulations, such as RDC 39/2013 and RDC […]
QR Group Explains How to Sell Class III and IV Medical Devices in Brazil: Certification and Compliance Requirements
Learn how to obtain the GMP certification required to register Class III and IV medical devices with ANVISA with the help of QR Group. To market Class III, Class IV or IVD medical devices in Brazil, it is essential that foreign manufacturers obtain Good Manufacturing Practices (GMP) certification from ANVISA. This process is crucial to […]
QR Group Explains ANVISA’s Good Manufacturing Practices Inspection for Medical Devices
Understand how GMP inspection impacts the registration of medical devices and how QR Group facilitates the compliance process. ANVISA requires that a Good Manufacturing Practices (GMP) Inspection be carried out at the facilities of manufacturers of risk class III and IV medical devices, whether national or international, as part of the process for product registration. […]
QR Group: How to Register Health Products with ANVISA and Ensure Compliance
Learn how QR Group can assist in the registration of health products with ANVISA and in the regulatory process to ensure entry into the Brazilian market. For a health product to be legally marketed in Brazil, it is essential that it goes through the registration process with ANVISA. This process involves a series of steps […]
