Australia’s Therapeutic Goods Administration (TGA) has introduced new formal notification requirements for custom made medical devices.
Amendments to the Therapeutic Goods (Medical Devices) Regulations 2002 passed in parliament during February have introduced a new Regulation 10.3 which provides specific time frames for notification.
This new regulation corrects a long awaited missing element of custom device controls. The regulations had always required TGA notification of supply of custom devices but until now time frames for notification were not defined nor was any formal process implemented by TGA.
Sponsors or Manufacturers must now notify TGA within 2 months of the either the manufacture (For Australian manufacturers), or the importation (for sponsors) of a custom made device. The regulator has also launched an online notification tool to ensure that users have simple means to notify the regulator.
What are Custom Made Devices?
Custom made medical devices are defined in the Therapeutic Goods (Medical Devices) Regulations 2002 as medical devices that are:
- Made specifically in accordance with a request by a health professional specifying its design characteristics or construction.
- Intended to be used only in relation to a particular individual, or by a health professional to meet special needs arising in the course of his or her practice.
They include dental crowns, bridges and dentures, prosthetic or glass eyes, orthopaedic or pedorthic footwear, prosthetic limbs, prescription glasses or and orthopaedic implants manufactured to fit a specific patient.
3D Printing – Custom Devices at the Bedside
One area where technology is challenging regulation is in 3D printing – where it’s possible to produce tailored implants – including manufacturer right there in the clinic. On 28th April 2016 I’ll be joining a workshop BioBriefing “Advances in 3D Printed Biomedical Devices” hosted by Monash Institute of Clinical Engineering and the BioMelbourne Network. Want to learn more? See you there. Click here to register.
If you currently supply custom devices to the Australian market and have not been notifying the regulator in accordance with regulation, be sure to contact us and get your Post Market activities under control. Email firstname.lastname@example.org or call our Sydney office on 02 9906 2984 for a free, no obligation, discussion of your needs.