EMERGO SUMMARY OF KEY POINTS:

• Brazilian regulators are introducing UDI requirements for high-risk devices including stents and implants.
• ANVISA’s new RDC 232/2018 brings UDI to the Brazilian market for the first time.
• Implementation of the regulation as well as a UDI database, the RNI System, is expected in 2020.

Brazil’s medical device market regulator ANVISA has published new requirements for Unique Device Identification (UDI) data to be included on labeling for certain higher-risk devices, marking the first time such rules have been issued in the country.

The new regulation, RDC 232/2018 (link in Portuguese), applies to coronary artery stents as well as implants for hip and knee arthroplasty procedures, and is intended to improve traceability of such devices in Brazail. ANVISA has harmonized the new regulation with UDI guidance from the International Medical Device Regulators Forum (IMDRF).

ANVISA UDI data requirements for stents, implants

According to RDC 232/2018, affected devices’ traceability labels will have to feature bar codes with information including device identifier, expiration date and lot or serial number. ANVISA registrants will have to provide three copies of traceability labels for use in medical records, patient documents and financial documents.

Bar codes will have to meet GS1 and Health Industry Business Communications standards in order to be accepted by ANVISA. The regulator has also begun setting up a UDI database, the RNI System, to store and manage UDI information.

The new regulation will come into effect two years after publication in the Brazilian government’s official diary (DOU).

 Luiz Levy, Director of RA/QA at Emergo in São Paulo, anticipates publication of RDC 232/2018 within the next months, as well as guidelines regarding the RNI System.

“The implementation of this regulation will ensure faster and more reliable information for traceability of these devices, and allow faster market actions by industry and ANVISA when necessary,” says Levy.

Related Brazilian medical device regulatory resources from Emergo:

• ANVISA medical device registration consulting
• ANVISA medical device post-market vigilance reporting support