FDAnews Device Daily Bulletin
Medical Devices / Regulatory Affairs

TGA Applies New Device Recall Procedures

Feb. 21, 2019

Australia’s Therapeutic Goods Administration has implemented new recall procedures that clarify when to quarantine products as well as how to communicate information about recalls.

The new system introduces two new types of recall actions: product defect corrections and product defect alerts. It also clarifies existing processes and explains the roles and responsibilities of the parties involved in recalls.

Under TGA regulations, recall actions may involve product defect corrections, hazard alerts for implanted devices with deficiencies, and recalls that take the device permanently off the market.

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