FDAnews Device Daily Bulletin
Medical Devices / Regulatory Affairs

Brazil Requires Pre-Approval for Custom Devices

Oct. 11, 2019
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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.

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