Brazil: New Risk Mitigation Regulation for Devices
A new regulation (RDC n o.23) published on 9 April 9 2012, requires marketing authorization holders to undertake a series of actions to reduce the risk associated by adverse events related to devices that are marketed in Brazil.
The required actions may involve the effective and timely recall of the product and the need to disseminate public warning messages.
The company must also report to ANVISA the actions it has undertaken, including the assistance it has provided to users, patients and others to reduce the risks related to the product. Companies will have 360 days to comply with the provisions of the new regulation.
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