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Regulation impact statement: Changes to premarket assessment requirements for medical devices
This Regulation Impact Statement (RIS) examines options to reform premarket assessment requirements for medical devices, and was prepared by the Therapeutic Goods Administration (TGA). The purpose of this RIS is to assist Australian Government decision making on how to address concerns raised in consultations regarding third party conformity assessment and increase the rigour of premarket regulatory assessment of higher risk 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.