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Medical Devices / Regulatory Affairs

TGA Seeks Feedback on Strengthening Spinal Implant Risk Classification

Feb. 13, 2019

Australia’s Therapeutic Goods Administration (TGA) invited comments on its proposal to reclassify all spinal implantable devices to a higher risk category.

The TGA’s plan is to move all spinal implantable medical devices — with the exception of some ancillary components — from Class IIb (medium to high risk) to Class III (high risk). The devices are used to treat trauma, spinal arthritis, deformities in the spine, herniated discs and spinal tumors.

The proposal looks to keep up with the EU’s medical device regulations, which “introduced several amendments to the classification rules effectively reclassifying some categories of medical devices to higher risk classes,” TGA said.

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