ANVISA Begins Review of RDC 81/2008: Impacts on Imported Products
QR Group analyzes the effects of the proposal to update the main rule that regulates the import of products subject to health surveillance in Brazil In 2024, ANVISA began the process of revising RDC No. 81/2008, a rule that for more than 15 years has established the requirements for importing products subject to health surveillance, […]
Challenges for companies and inspectors in interpreting the requirements of legislation and international standards of Health Surveillance
One of the biggest challenges for companies that manufacture or import/distribute health products is understanding and/or interpreting regulatory requirements, whether they are resolutions/legislation or international standards of the Health Surveillance Agency. The applicability of certain requirements in certain segments must be carefully assessed by both companies and authorities, which makes the inspection process by health […]
