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Custom-made medical devices - Therapeutic Goods …
- https://www.tga.gov.au/how-we-regulate/manufacturing/medical-devices/manufacturer-guidance-specific-types-medical-devices/personalised-or-custom-made-medical-devices/custom-made-medical-devices
- You will need to be a client of the TGA with access to the TBS online portal before you can complete a notification form for a custom-made medical device. There are instructions …
Regulatory framework for personalised medical devices: …
- https://www.tga.gov.au/resources/resource/guidance/regulatory-framework-personalised-medical-devices-frequently-asked-questions
- On 20 August 2021, refinements were made to the personalised medical devices framework, including a legislative instrument known as the Therapeutic Goods …
Personalised medical devices | Therapeutic Goods …
- https://www.tga.gov.au/how-we-regulate/manufacturing/manufacture-medical-device/manufacture-specific-types-medical-devices/personalised-medical-devices
- Both patient-matched and custom-made medical devices are personalised before they are manufactured. Dental aligners, for example, are a patient-matched medical device that …
Custom-made medical devices - Therapeutic Goods …
- https://www.tga.gov.au/sites/default/files/custom-made-medical-devices.pdf
- Therapeutic Goods Administration Custom- made medical devices - Information for sponsors health professionals and manufacturers V4.1 October 2022 Page 8 of 13 …
Personalised medical devices (including 3D-printed …
- https://www.tga.gov.au/resources/resource/guidance/personalised-medical-devices-including-3d-printed-devices
- Personalised medical devices (including 3D-printed devices) Information and examples to help you understand the regulatory framework for personalised …
Personalised Medical Devices(Including 3D-Printed …
- https://www.tga.gov.au/sites/default/files/personalised-medical-devices-including-3d-printed-devices.pdf
- Therapeutic Goods Administration Personalised medical devices (including 3D-printed devices) V5.1 August 2022 Page 9 of 32 process is reproducible. This does not mean …
Medical devices reforms: Personalised medical devices
- https://www.tga.gov.au/how-we-regulate/manufacturing/medical-devices/manufacturer-guidance-specific-types-medical-devices/personalised-or-custom-made-medical-devices/medical-devices-reforms-personalised-medical-devices
- Prior to 25 February 2021, most personalised medical devices (PMD) met the definition of 'custom-made' and were exempt from the requirement to be approved by the …
Regulation impact statement: Proposed regulatory …
- https://www.tga.gov.au/resources/publication/publications/regulation-impact-statement-proposed-regulatory-scheme-personalised-medical-devices-including-3d-printed-devices
- Personalised medical devices range dramatically in type and form - from prosthetics and implants to devices made using emerging technologies and advanced manufacturing …
TGA Notice on Custom-Made Medical …
- https://www.regdesk.co/tga-notice-on-custom-made-medical-devices/
- The initial definition of a custom-made medical device is set forth in the Therapeutic Goods (Medical Devices) Regulations 2002. The authority also …
TGA Compliance of Custom Made Medical Devices - Andent
- https://andent.com/tga-compliance/
- •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 …
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