Regulatory updates from the TGA Medical Devices Branch - Part 1

Regulatory updates from the TGA Medical Devices Branch - Part 1

• 1.
  Session B19: Regulatoryupdates from the TGA Medical Devices Branch Dr Elizabeth McGrath Director, Medical Devices Emerging Technologies Unit, Medical Devices Branch Mimi Chu-Gourlay Assistant Director, Medical Devices Reforms Unit, Medical Devices Branch 7 August 2019
• 2.
  Overview - Part1 • Review of Medicines and Medical Devices Regulation (MMDR) • Proposed changes to some definitions and regulation of some products without a medical purpose • Reclassification of medical devices (not IVD) • Unique Device Identification (UDI) System • Post-market monitoring 1
• 3.
  Review of Medicinesand Medical Devices Regulation (MMDR) • Government accepted Recommendation 20: 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. • Consultations closed: – Changes to some definitions and regulation of some products without a medical purpose – Reclassification of medical devices (not IVD) (7 consultations) – Unique Device Identification (UDI) System for medical devices (including IVDs) • Consultations to be published: – Proposed changes to the essential principles, conformity assessment procedures, requirements for devices used in clinical trials, classification of devices containing nanomaterials 2
• 4.
  Changes to somedefinitions and regulation of some products without a medical purpose • Consultation: Changes to a number of definitions and the scope of the medical device regulatory framework in Australia (https://www.tga.gov.au/consultation/consultation-changes-number-definitions-and-scope-medical-device-regulatory-framework-australia) – Opened 7 January 2019 |Closed 18 February 2019 • Proposal: – Harmonise Australian legislation and regulation with definitions in the EU MD Regulation – Regulate some products without a medical purpose as medical devices • Submissions: – 21 submissions received from a range of stakeholders (industry, consumer advocacy groups, professional bodies, and other government organisations) – Some questions raised about some groups of definitions from the EU MD Regulation – General support for regulation of products without a medical purpose, with strong support for regulation of decorative contact lenses and brain stimulation devices without a specific medical purpose – Some questions about regulation of products for beauty therapy (e.g. personal IPL devices) 3
• 5.
  Reclassification of medicaldevices (not IVD) Consultations (https://www.tga.gov.au/medical-devices-ivds-closed-consultations-reviews) • Opened: 7 January 2019 | Closed: 18 February 2019 – Active medical devices for therapy with diagnostic function • Opened: 11 February 2019 | Closed: 31 March 2019 – Spinal implantable medical devices • Opened: 6 March 2019 | Closed: 29 April 2019 – Medical devices used in direct contact with the heart, central circulatory or central nervous systems – Medical device classification for human cells, tissues and organs storage solutions and IVF media – Substances introduced into the body via a body orifice or applied to the skin – Active implantable medical devices and their accessories – Medical devices that administer medicines or biologicals by inhalation Benefit Risk 4
• 6.
  Reclassification of medicaldevices (not IVD) continued… • Submissions: – 56 submissions received to the 7 consultations – Received from a range of stakeholders (industry, consumer advocacy groups, professional bodies, healthcare professionals and other government organisations) – Strong support to align the classification rules in Australia with the EU MD Regulations – Some questions raised on lack of clarity on the intent in some of the EU classification rules  TGA has undertook further targeted discussions with some of the relevant stakeholders (e.g. spinal implantable medical devices, active implantable medical devices and their accessories)  TGA intends to engage further with relevant stakeholders regarding some other proposals (e.g. about medical devices that are human cells, tissues and organs storage solutions and IVF media) – Some questions raised not directly relevant to the consultations 5
• 7.
  Unique Device Identification(UDI) System for medical devices (including IVDs) Consultation • Proposal to introduce a Unique Device Identification (UDI) system for medical devices in Australia (https://www.tga.gov.au/consultation/consultation-proposal-introduce-unique-device-identification-udi-system-medical- devices-australia) – Opened 7 January 2019 | Closed 18 February 2019 – UDI System is intended to provide a single, globally harmonised system for identification of medical devices. It is intended to be used to uniquely identify medical devices through their distribution and use. 6
• 8.
  Unique Device Identification(UDI) System for medical devices (including IVDs) • Submissions: − 49 submissions received from a range of stakeholders (industry, healthcare organisations, consumer advocacy groups, research institutions, and other government organisations) − Strong support for the introduction of the UDI System and establishment of the UDI database (AusUDID) − Some issues raised related to UDI labelling requirements, AusUDID requirements, responsibilities for entering data into the AusUDID • If a decision is made to introduce the UDI System, open and targeted consultations will be considered to engage different stakeholders’ groups through the supply chain 7
• 9.
  Post-market monitoring • Updatingthe adverse event database – Improved reporting forms for consumers and health professionals – reporting is easier with minimal information required – Reporting forms for sponsors changed to reflect changes in the database – future consultation regarding the Action Plan will impact the reporting forms • Classification changes will impact on the reporting requirements from sponsors – More ARTG entries will be at the Class III level meaning more ‘Annual Reports’ • Aligning with the EU and other regulatory agencies – Periodic Safety Update Reporting (PSUR) • Consultation – PSUR – Exemption rules – Inspections – Mandatory reporting – Publishing decisions 8
• 10.
  Further information • Medicinesand Medical Devices Regulation (MMDR) Review hub: https://www.tga.gov.au/hubs/mmdr • Subscribe to TGA’s consultations email list: https://www.tga.gov.au/tga-consultations-email-list • Contact the TGA Medical Devices Branch: [email protected] ph: 1800 141 1444 • Contact the TGA Device Reforms Unit: [email protected] 9