Australian TGA Regulatory Changes for Implantable Medical Devices Starting in December 2018
Regulatory Updates | Medical Devices
EMERGO SUMMARY OF KEY POINTS:
- Australian regulators will begin requiring some implantable medical device manufacturers to provide additional product information to patients starting in December 2018.
- The Therapeutic Goods Administration (TGA) will also require up-classification of surgical mesh devices to Class III starting in December.
- These changes will align TGA device registration requirements more closely to the European Medical Devices Regulation (MDR).
The Australian government is set to begin requiring new market registrants of some implantable medical devices to provide detailed consumer information leaflets with their products on December 1, 2018 as part of a broader effort to align Therapeutic Goods Administration (TGA) regulations with the European Medical Devices Regulation (MDR).
According to the Australian government’s schedule, the leaflet requirements apply to new registrations for permanently implantable devices in December 2018; the requirements will apply to all existing registrations for such devices on December 1, 2021.
Australian regulators have also specifically targeted manufacturers of surgical mesh devices for new requirements:
- TGA will up-classify all new registrations for surgical mesh devices to Class III starting December 1, 2018; existing urogynecological surgical mesh device registration holders have until December 1, 2020 to submit reclassification applications to TGA, while registrants that manufacture all other types of surgical mesh devices have until December 1, 2021 to submit such applications.
- TGA will require manufacturers of all existing urogynecological mesh device registrations to comply with leaflet rules starting December 1, 2019.
TGA guidance provides specifics
Guidance from TGA specifies which types of implantable devices fall under the new reclassification and consumer leaflet requirements:
- Any device partially or wholly absorbed intended either to be totally introduced into the human body or to replace an epithelial or eye surface;
- Any device intended to be partially introduced into the body via clinical intervention and intended to remain in place for at least 30 days.
TGA also lists examples of devices that do not fall under the new consumer information requirements. These include sutures and staples, dental filings and braces, screws, plates, wires and clips.
For devices falling under these definitions, manufacturers must provide both patient implant cards and patient information leaflets.
- Patient implant cards: portable cards provided to patients post-surgery who have received permanent implantable devices or active implantable devices; a card must include a device name, type and model as well as manufacturer’s contact details.
- Patient information leaflets: brochures providing information to patients about the implantable devices they accompany; leaflets should provide information on the type of device in question as well as on medical conditions and types of patients the device targets. In some instances, electronic versions of leaflets may be used.
Patient implant cards and information leaflets will be subject to TGA review during regulatory assessments of their associated devices, according to the guidance.
Related Australian TGA regulatory resources from Emergo by UL:
- Australian TGA medical device registration consulting
- Australian TGA Sponsor in-country representation
- Medical Device Single Audit Program (MDSAP) internal and gap audit support
- Video overview: Australia’s medical device approval process
- Regulatory process chart: Australian TGA medical device registration