Clarified Reclassification Rules from TGA for Implantable Devices
Australia’s Therapeutic Goods Administration (TGA) will allow registered manufacturers of partial knee, hip and shoulder implants to submit summary technical reports as part of their reclassification applications through June 30, 2014.
Australian regulators made the allowance following reports that some TGA registrants have been unable to obtain design examination certificates from their European Notified Bodies (NBs) within timeframes required for reclassification of qualifying devices from Class IIb to Class III under the Australian Register of Therapeutic Goods (ARTG).
For registrants dealing with this issue, TGA will accept summary reports as interim evidence until manufacturers can obtain complete examination evidence documentation from their NBs. Summary technical reports should include at least the following three components:
- A positive recommendation on the device’s design examination or conformity assessment procedure
- Compliance with all Class III medical device requirements in Europe
- Certification of the manufacturer’s quality management system according to European Medical Device Directive 93/42/EEC
The TGA’s reclassification transition for partial hip, knee and shoulder joint implant devices ends June 30, 2014; any devices whose manufacturers miss that deadline will be removed from the ARTG. Affected manufacturers should plan accordingly to keep their Australia medical device registrations valid.