Updated August 2022
The Therapeutic Goods Association have recently sent correspondence regarding Personalised Medical Devices (custom made and patient matched medical devices).
Please visit this site to hear a message from the Deputy CEO, ADA Federal, Ms Eithne Irving on 30 August 2022 that explains what this means for you:
ADA Federal – Personalised Medical Devices Update
If you have further questions and would like to speak with a Peer Advisor – please email your question to: advisory@adansw.com.au.
Custom made (patient-matched) medical devices and the TGA
The TGA have introduced a new regulatory framework with the intention of ensuring that all medical equipment/devices issued to patients in Australia are subject to a degree of regulatory oversight to ensure they are safe and fit for purpose.
Implications for dentistry:
- Products excluded from TGA regulation: Include those assessed as being low risk and those appropriately regulated elsewhere: Therapeutic Goods (Excluded Goods) Determination 2018 (legislation.gov.au). Dental examples include: mouthguards, impression trays; working models.
- Medical devices exempt from inclusion in ARTG: If you are a healthcare practitioner, or someone (for example a laboratory technician) who is working to instructions/directions received from a healthcare practitioner and you are using materials or components named in: Therapeutic Goods (Medical Devices—Specified Articles) Amendment (Personalised Medical Devices) Instrument 2021 (legislation.gov.au)that have been included in the ARTG, the device you make will be exempt from inclusion in the ARTG. You are not required to register your devices for transition or include them in the ARTG. Dental examples include restorative procedures, prostheses, study models, splints, crown and bridge etc.
NB: You will still need to meet all other regulatory requirements for your medical device including:- Ensuring it meets all relevant Essential Principles (including supplying the devices with adequate labelling and instructions for use);
- Reporting adverse events to the TGA; and
- Meeting the advertising requirements for therapeutic goods under the TGA legislation including the Therapeutic Goods Advertising Code.
The recent change announced on 8 November 2021:
Relates to an additional amendment: Therapeutic Goods Legislation Amendment (2021 Measures No. 3) Regulations 2021.
The deadline for application for transitional arrangements (for everything other than 1 and 2 above) is now extended to 25 Aug 2022. This includes Medical Device Production Systems (MDPS) eg. Cerek and 3-D printed etc manufacturers. Manufacturers of these systems/products now:
- Only need one ARTG entry for each “kind of device” supplied or manufactured
- Only need an ARTG listing if devices are supplied in quantities greater than five per financial year
Sponsors:
If you are directly importing a material, component(s) or finished medical devices for use in your practice from overseas, you will still need to include these products in the ARTG.
TGA Frequently Asked Questions
Additional information can be found here:
Regulatory framework for personalised medical devices: Frequently asked questions | Therapeutic Goods Administration (TGA)
What if I don't want to be a sponsor/importer?
- Make sure any medicaments, materials, equipment, devices you are using in your practice are ARTG listed and approved
- Only source materials/equipment/devices from Australian-based suppliers/entities – ask your supplier/laboratory to certify their products have been manufactured in accordance with Australian standards, are ARTG listed and are approved for use in Australia
- Liaise with your Australian-based laboratory or technician about the requirement to provide patients with instructions when issuing appliances and medical devices (such as crowns, dentures etc).
What are your responsibilities when importing medical devices from overseas?
Health professionals who import medical devices for use in their clinical practice are considered to be supplying the devices to the general public. Examples of importing medical devices include purchasing from overseas through the internet or from mail order catalogues, or obtaining from international conferences and trade exhibits.
Importing and supplying medical devices | Therapeutic Goods Administration (TGA)
Is there anyone who can help with TGA general/business enquiries?
SME Assist is a dedicated TGA service to help small to medium enterprises (SMEs), researchers, start-ups and those unfamiliar with therapeutic goods regulation understand their regulatory and legislative obligations.
SME Assist | Therapeutic Goods Administration (TGA)
Phone: 1800 14 11 44
What are the penalties if you do not meet TGA regulatory requirements?
Sponsors and health professionals who do not comply with the import and supply regulations for medical devices could face civil or criminal penalties of up to five years imprisonment and/or 5000 penalty units (one penalty unit is currently valued at $170 under the Crimes Act 1914). Read more here.
July 2021: Canberra dental practice fined $266,400 for alleged unlawful supply of dental implants and bone grafts. Click here for details.
