With the intention of aligning the TGA (Therapeutic Goods Administration) regulations with the European MDR (EU) 2017/745, starting December 1, 2018, the Australian government will require that some active implantable and implantable Medical Devices be provided with consumer information materials (e.g. the patient implant card and patient information leaflet).
Modifications to Australian TGA regulations apply to all new registrations for permanently implantable devices that fall under the definition of “implantable device ” as required by the MDR, meaning “any device, including those that are partially or wholly absorbed, which is intended:
- to be totally introduced into the human body, or
- to replace an epithelial surface or the surface of the eye,
by clinical intervention and which is intended to remain in place after the procedure.
Any device intended to be partially introduced into the human body by clinical intervention and intended to remain in place after the procedure for at least 30 days shall also be deemed to be an implantable device “.
Subsequently, by December 1, 2021, these requirements will apply to all existing registrations for the above-mentioned devices.
