Session B19: Regulatory updates from the TGA Medical Devices Branch - - PowerPoint PPT Presentation
Session B19: Regulatory updates from the TGA Medical Devices Branch Part 2 Dr Elizabeth McGrath Director, Medical Device Emerging Tech | Medical Device Reform Program Mimi Chu-Gourlay Assistant Director, Medical Devices Reforms Unit,
Dr Elizabeth McGrath Director, Medical Device Emerging Tech | Medical Device Reform Program Mimi Chu-Gourlay Assistant Director, Medical Devices Reforms Unit, Medical Devices Branch 7 August 2019
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The regulation of medical devices in Australia, wherever possible, should be aligned with the European Union (EU) framework, including in respect of the classification of medical devices and essential principles/requirements.
– The Regulation of Software including Software as a Medical Device – Proposed Regulatory Scheme for Personalised Medical Devices, including 3D Printed Devices
– Proposed changes to the essential principles, – Proposed changes to the conformity assessment procedures, – Proposed changes to the requirements for devices used in clinical trials, – Clarifying the requirements for systems and procedure packs
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https://www.tga.gov.au/consultation/consultation-regulation-software-including-software-medical-device-samd
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1. Introduce new definitions for personalised medical devices 2. Change the requirements for supplying custom-made medical devices in Australia, so that additional information must be provided to the TGA and to patients and, to allow the TGA to inspect manufacturing sites 3. Introduce a framework for regulating a medical device production system which will allow healthcare providers to produce lower risk personalised devices for treating their patients, without the need for manufacturing certification 4. Update the classification rule for medical devices that record diagnostic images so that it includes any device for this purpose and not just X-rays, for example 3D-printed models of patient anatomy 5. Regulate medical devices with a human origin component, for example a 3D-printed implant incorporating cells from the patient, as medical devices with a biological component rather than as pure biologicals, and 6. Clarify that any modifications or adaptations to personalise a medical device that has already been supplied must have been intended by the original manufacturer of the device.
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Presentation title 9
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Changes to medical device Essential Principles
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performance and IMDRF Principles for Labelling of medical device and additional requirements in EU MD and IVD regulations.
NEXT STEPS – Public consultation paper to be released soon…
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Clarification of Requirements for Systems and Procedure Packs A system or procedure pack (SOPP) is a package containing therapeutic goods put together for use as a unit either in combination as a system or for use in a medical or surgical procedure. Current requirements lack clarity regarding the conformity assessment pathways requirements such as ambiguity in conformity assessment pathway used for medical devices with special purpose. External Workshop conducted: Feedback on issues obtained from participants - included representatives from Industry, hospitals and consumer health forums Reform Intent– Introduce reforms that provide greater clarity to ensure regulatory compliance to improve safety and performance of medical devices.
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– the requirement that the manufacturer of a SOPP must obtain conformity assessment document from the TGA, a comparable overseas regulator or assessment body, from the manufacturers of each medical device they put into the SOPP. – if the manufacturer of a SOPP intends to open or modify the packaging of any goods when these goods are put into the SOPP, the manufacturer of the SOPP must have a written agreement, with the manufacturers of the respective goods they unpackage, that will allow validation that such a production step does not impact on the performance of the goods. NEXT STEPS – Public consultation paper to be released soon…
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Changes to medical device Conformity assessment procedures All medical devices to be supplied in Australia, must apply minimum applicable conformity assessment procedures and have appropriate documentation to demonstrate compliance of the medical device with the relevant essential principles. Current procedures do not cover sufficient detail of assessment based on the risks related to device design and manufacture, particularly in areas of advancing medical technology including custom made medical devices. Reform Intent – Introduce changes to conformity assessment procedures and revised conformity assessment pathways to reduce ambiguity and increase transparency and robustness of assessment.
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technical documentation for certain implantable devices to ensure risk based regulatory oversight. For example: Class IIb implantable to now require individual product assessment, to ensure appropriate scrutiny of safety and performance.
clinical data and clinical studies for medical devices to ensure the data requirements are clear and transparent.
enable appropriate use of the device, and allows manufacturers to perform investigations when required. NEXT STEPS – Public consultation paper to be released soon…
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Requirements for Medical Devices used in Clinical Trials TGA is responsible for regulation of import, export and/or supply of medical devices for use in clinical trials in Australia under the Therapeutic Goods Act 1989. Current procedures do not provide for adequate oversight of the adequacy
Reform Intent – Introduce changes to regulation of clinical trials to have appropriate regulatory oversight based on the potential risks of the device to ensure safety of Australian Clinical trial participants.
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For a medical device to be supplied in Australia, the device needs to meet relevant Essential Principles (EPs). Compliance with EPs: Pre-clinical testing + Clinical evaluation Need for review of pre-clinical safety data before human testing Proposal: High risk implantable devices required to undergo assessment and approval by TGA through the CTX pathway, consistent with the international requirements
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https://www.tga.gov.au/hubs/mmdr
https://www.tga.gov.au/tga-consultations-email-list
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