TGA Solicits Comments on Mesh Device Reclassification Plan

Australia’s Therapeutic Goods Administration invited comments from stakeholders on its plans to reclassify surgical mesh devices to better align with European rules.

The agency proposes to  reclassify such devices from Class IIb to Class III devices. The change will require manufacturers whose class IIb devices are already on the market to obtain further conformity certifications for design examination, while all new applicants will follow the normal Class II pathway.

The agency is proposing a three-year implementation window, giving devicemakers through the end of November 2020 to apply for re-classification. This will begin with a six-month period for Class IIb devicemakers to inform the agency that they plan to re-apply.