QR Group performs internal audits and GMP inspections for healthcare supply chain suppliers
Find out how QR Group’s internal audits and inspections ensure compliance with RDC 665/2022 and agility in product registration Focusing on internal audits, QR Group offers Good Manufacturing Practices (GMP) inspections at suppliers, preparing manufacturers to meet ANVISA requirements and ensure compliance in records. In this text, we explain the process and benefits for medical […]
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), […]
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. […]
ANVISA’s Participation in WHO: Impacts on the Regulation of Medical Products
Understand the Importance of ANVISA’s Role in the Global Product Regulation ANVISA is participating in the 13th plenary meeting of the Member States Mechanism on Substandard and Falsified Medical Products (MSMSF) of the World Health Organization (WHO), reinforcing its essential role in product regulation at the international level. The event will take place between November […]
