Dedicated Import of Medical Devices in Brazil
Integrated solutions for regulatory and logistics access Importing medical devices efficiently requires a dedicated process ranging from market research to customs clearance. QR Group performs a full dedicated import service, coordinating each step with technical and regulatory precision. Starting with the correct classification of the product, through the appointment of a local representative or qualified […]
Training in Quality Management Systems for Medical Devices
Training: Driving Quality and Compliance in the Healthcare Industry QR Group offers a series of specialized training to enhance quality systems in medical device manufacturers, aiming at compliance with standards such as RDC 665/2022, ISO 13485, ISO 14971 and CAPA processes. Our goal is to train employees to monitor risks, measure performance, and ensure continuous […]
Medical Device Registration: Agile Compliance with ANVISA
Understand the Medical Device Registration Process at ANVISA Ensuring access to the Brazilian market requires a detailed regulatory process, especially in the registration of medical devices with ANVISA. QR Group’s registration service was developed to facilitate this journey, ensuring compliance, agility, and strategy for companies that want to operate safely in the health sector. Complying […]
QR Group implements Quality Assurance and compliance systems for medical devices
See how QR Group’s Quality Assurance service ensures ISO 13485 standards and compliance with GMP and ANVISA standards QR Group offers a complete quality-assured service, helping manufacturers implement quality management systems to ensure compliance with ISO 13485, RDC 39/2013 and RDC 15/2014. In this article, we explain how this service strengthens control and efficiency in […]
QR Group offers advice on regulatory matters for product registration with ANVISA
Understand how QR Group’s regulatory affairs advice speeds up ANVISA approval for national and international manufacturers With a focus on regulatory affairs, QR Group offers complete advice for product registration with ANVISA, aiming to ensure compliance and agility in accessing the Brazilian market. In this content, we explain how this personalized advice strengthens the entry […]
Understand the Requirements of IN 242/2023 and How to Ensure Regulatory Compliance
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 […]
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), […]
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 […]
