Brazil Requires Pre-Approval for Custom-Made Devices

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 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 those devices.

Patient-specific devices are those that have been modified for a specific person’s anatomy using anatomical imaging or other sizing techniques. Manufacturers of these devices also must seek approval to manufacture a patient-specific device. The agency is allowing a 24-month transition period for manufacturers of these devices that are currently marketed in Brazil.

A device that is mass produced but later adjusted or modified based on a device manufacturer’s instruction is considered an adaptable medical device. No transition period is available for these devices.

Patient-specific Class III and Class IV medical devices will be reviewed on a case-by-case devices, ANVISA said.