www.fdanews.com/articles/193039-brazil-requires-pre-approval-for-custom-devices
Brazil Requires Pre-Approval for Custom Devices
October 10, 2019
Brazil’s ANVISA issued a new regulation for custom-made medical devices that includes new requirements for manufacturing, marketing and importing such devices.
In line with the International Medical Device Regulators Forum, Brazil’s regulation (RDC 305/2019) makes the distinction between custom-made devices, patient-specific devices and adaptable devices.
Under the definition, custom-made devices are made specifically for individual patients and manufacturers must seek approval from ANVISA to manufacture them.