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Regulation impact statement: Changes to premarket assessment requirements for medical devices

26 June 2013

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This Regulation Impact Statement 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.

Version history

Version Description of change Author Effective date
V1.0 Exposure draft Office of Devices Authorisation 10/05/2013

Regulation Impact Statement

Certified by Office of Best Practice Regulation on 26 June 2013 (ref 14680)

Office of Devices Authorisation 26/06/2013

© Commonwealth of Australia 2013
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