Label maintenance and updating is the process of ensuring that the data on the label stays up-to-date and accurate throughout the life cycle of the device. This could entail updating information to meet new laws or standards, amending the existing labels to reflect changes in the product or its intended use, or fixing typographical errors.
The Brazilian Health Regulatory Agency, ANVISA, issued Resolution RDC 751, which recently specified the standards and guidelines for the notification, registration, post-approval modifications, and revalidation of medical devices in Brazil. ANVISA’s Resolution of the Board of Directors (RBD) No. 751/2022 was recently published and has been effective from March 01, 2023.
With technological advancements, the adoption of wireless medical devices for patients and healthcare management is growing at a fast pace. It is anticipated that four (04) out of ten (10) medical devices installation will be wireless or portable by 2031, and the wireless portable medical device market is expected to reach USD 33 billion. The wireless medical devices utilize radiofrequency communication such as wi-fi, Bluetooth, cellular or mobile phones. Interoperability is the key feature of these technologies, and all the related concerns are applicable.
