TGA changes to the regulation of Custom-Made Medical Devices
The TGA has recently published changes to the regulatory framework for medical devices, which applies to all dental laboratory products. We welcome these changes to the regulations, and fully support the actions by the TGA to improve the quality of medical devices supplied in Australia.
We are proud of the measures we have implemented to ensure our customers, and their patients, receive the highest quality product and services. Our rigorous Quality Assurance approach encompasses the materials used in the manufacturing processes, advanced equipment, highly qualified and trained staff, quality control processes, regulatory compliance, and IT systems.
At Andent we fully comply with the TGA regulations, and exceed the minimum required standards in a number of ways.
The main impact of the TGA changes is that most of the devices currently being supplied as custom-made medical devices will need to be approved by the TGA and included in the Australian Register of Therapeutic Goods (ARTG). There is a transition period underway, and laboratories have until November 2024 to list their devices on the ARTG.
Required TGA Compliance
•We have already notified the TGA of all custom-made medical devices that we manufacture and supply by 25 February 2021.
•We comply with the Essential Principles as defined in the Therapeutic Goods (Medical Devices) Regulations 2002.
Voluntary Quality Management
•All the materials used in our devices (such as porcelain, zirconia, acrylics, metal alloys) are sourced from reputable international supply companies such as Ivoclar Vivadent, Vita, 3M etc. Where we import these materials from overseas, we voluntarily list the items on the ARTG.
•All Material Safety Data Sheets recorded.
•Our infection control protocols are available online, and are compliant with Dental Board of Australia, Australian Dental Association Guidelines and Australian/New Zealand Standards. Modern Dental Group protocols in China and Hong Kong are aligned with The Guideline for Disinfection and Sterilization in Healthcare Facilities (Centre for Disease Control, 2008).
Want further information about our regulatory compliance?
Please feel free to contact our Customer Service team on 03 9650 6766 and we will be happy to provide you with further information.
The Andent Team