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UDI Requirements Come to Brazil

 
• By Elizabeth Orr

A new regulation from Brazilian device regulator ANVISA will require some high-risk devices to carry Unique Device Identifiers. The rule, which will come into effect in 2020, is the first time the country has mandated UDIs.

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Coronary stents and some orthopedic implants will need to carry Unique Device Identifiers to be sold in Brazil as of 2020 thanks to a new regulation from Brazilian device regulators ANVISA. This is the first time the country has issued any rules around UDIs, according to industry experts.

The regulation, RDC 232/2018 (link in Portuguese), lays out UDI requirements for some high-risk devices, including conventional and drug-eluting...

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