RDC 848/2024
Marcelo Brisolla
CEO I Senior Executive I Legal Expert | Regulatory Affairs I Healthcare I Medical Devices I Environmental Health Consultant I BPO in RA I Services I ANVISA
In September 2024, Collegiate Board Resolution (RDC) No. 848 will come into force, imposing strict new guidelines on the safety and performance evaluation of medical devices in Brazil. These regulations, in line with international standards such as ISO 14971 and ISO 10993, reinforce the importance of comprehensive testing and detailed documentation to ensure that medical devices are safe for clinical use.
The new RDC aims to ensure that medical devices do not pose undue risks to patients, healthcare professionals or third parties, and that they perform as expected under real clinical conditions. The process involves risk analyses, tests for compliance with safety standards and biocompatibility studies, as well as functional and clinical validations.
To find out more about how this new regulation will impact the department and the steps needed to ensure the compliance of medical devices, read the full article on our blog. Be sure to check it out and keep up to date with best practices and regulatory requirements for medical devices.
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