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Regulation impact statement: Premarket assessment requirements for Australian manufactured medical devices
OBPR Reference: 17059
This Regulation Impact Statement (RIS) has been prepared by the Therapeutic Goods Administration (TGA). The purpose is to assist Australian Government decision making on how to address the problems that have been identified in relation to the premarket assessment requirements for Australian manufactured medical devices.
After a decision has been made, the RIS needs to be made public. In general terms, this means that the RIS must be posted on the central online RIS register maintained by the Office of Best Practice Regulation (OBPR). Further information on regulatory impact analysis can be found at the OBPR website.
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