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Joint reclassification advice: Extension of the timeframe for TGA to select a reclassification application for audit
Medical devices reforms
A regulatory amendment has been enacted to extend the timeframe for an application for reclassification of a joint implant to be selected for audit from 20 working days to 60 working days.
What does this mean?
The Therapeutic Goods (Medical Devices) Amendment (Auditing Applications) Regulation 2014 means that the TGA has up to 60 days in which to select an application to reclassify a Class IIb hip, knee or shoulder joint implant (reclassification application) for audit.
Why is this happening?
This extension of the normal timeframe from 20 to 60 days is to provide more time for the TGA to review the additional information about the joint implant to determine if an audit is necessary.
What other effects does it have?
This amendment to the regulations only applies to applications to reclassify partial and total hip knee and shoulder joint implants from class IIb to class III under Part 11 of the Regulations.