Personalised Medical Devices Framework - Regulatory changes to custom-made medical devices - TGA
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Personalised Medical Devices Framework Regulatory changes to custom-made medical devices Rebecca Bateson Assistant Director, Devices Emerging Technology and Diagnostics Medical Devices Surveillance Branch Therapeutic Goods Administration, Department of Health 16 February 2021
Today’s presentation
• Overview of the new framework
– Changes to custom-made medical devices
– Patient-matched medical devices
– Adaptable medical devices
• Regulatory terminology
• Worked examples
1
Overview
• Custom-made medical devices exempt from inclusion in the ARTG under the
Therapeutic Goods (Medical Devices) Regulations 2002
• Traditionally these devices were low risk
• Rapid advances in technology mean they can now be high risk
• Public consultation and collaboration through the International Medical Device
Regulator’s Forum
• A new regulatory framework for personalised medical devices commencing on
25 February 2021
2
Overview of the changes
3
Custom-made medical devices
• Continue to be exempt from inclusion in the ARTG
• Excludes
– Patient-matched devices (new definition)
– Adaptable medical devices (new definition for an existing concept)
• New obligations
– Information to be supplied with the device
– Record keeping requirements
a minimum of 5 years after the date of
manufacture if the device is
non-implantable; or
a minimum of 15 years after the date of
manufacture if the device is implantable.
– Annual reporting
– Inspection and review 4
25 February 2021 – new regulatory 01 October 2021 – first
requirements commence annual report due
Custom-made medical devices (new
definition)
Exempt from inclusion in the ARTG
Must meet the essential principles
Must notify the TGA of supply
Custom-made medical
devices
Exempt from inclusion in the ARTG
Statement from the manufacturer
Must meet the essential principles to be provided with the device
Must notify the TGA of supply
Record keeping and annual
reporting requirements commence
Allow entry and inspection
Provide documentation when
requested
Patient-matched medical devices
• Manufactured within a “design
envelope”
• Production processes can be
validated, verified or reproduced
• No longer exempt – must be
included in the ARTG
• Notify the TGA by 25 August
2021 to access transition
arrangements
• Submit an application for inclusion
before 1 November 2024
6
25 February 2021 – new definition
commences
01 November 2024 – transition period
25 August 2021 – notification period
ends
for transitional devices ends
Patient-matched medical devices Patient-matched medical devices
Transition period for eligible manufacturers Must be included in the ARTG
Custom-made medical and suppliers
devices that will meet the New devices must be included in the ARTG
definition of a patient-
matched medical device
Notify the TGA that you will be Acquire appropriate conformity
transitioning your custom made assessment evidence/certification
medical device to a patient-
matched device included in the
ARTG
Submit an application for inclusion
in the ARTG
Design envelope
• Manufactured within a “design envelope”
• Processes that can be validated, verified and
reproduced
Layman’s example: construction of windows for building
versus windows for a submarine designed to visit the
bottom of the Mariana Trench
For orthotists and prosthetists: the difference between
designing a transfemoral prosthesis for most people
versus someone whose anatomical features fall outside
the limits of ready-made components and materials
8
Medical Device Production System
• A validated, multi-component design and production system that a
manufacturer can supply to health professionals and healthcare facilities, to
produce a specific type of personalised medical device in-house.
Production
equipment (e.g.
computer-aided
design (CAD)
programs, 3D
printers)
Device intended to be
Raw materials produced by the
system
Medical
Device
Production
System
(MDPS)
9MDPS Continued
• COMING SOON – definition commences 25 February but there’s more work to
be done before MDPSs can be included in the ARTG.
• Health professionals (or a suitably qualified person within a healthcare facility)
who use an MDPS to produce a medical device will not need to meet the
regulatory obligations of a manufacturer.
• The MDPS must:
– be included in the ARTG;
– classified at the same level as the device it
produces; and
– be supplied with comprehensive instructions
to allow the healthcare professional (or
qualified person) to safely produce a device
commensurate with the intended purpose
of the MDPS.
10Adaptable medical device
• A new definition for an existing concept
• Mass-produced and designed to be modified at the point of care to suit
a particular patient.
• Definition introduced to provide clarity
• Adaptable medical devices continue to
require inclusion in the ARTG before they
can be supplied.
• Essential principle 13.4(3) will specifically
require adaptable medical devices are
supplied with instructions to allow safe
modification/assembly at the point of care.
11Regulatory terminology
Manufacturer
• Described in Section 41BG of the Therapeutic Goods
Act 1989
• Essentially – the person responsible for the design,
production, packaging and labelling of a device
(meeting the Essential Principles).
• Refurbishing, reprocessing, repackaging and relabelling may meet the
definition of manufacture.
• Changing the intended purpose of a product may meet the definition of
manufacture (relabelling, repackaging or promoting a different intended
purpose) .
You are not a manufacturer if you assemble or adapt the device for an
individual patient and the assembly or adaptation does not change the
intended purpose of the device.
12Regulatory terminology continued
Sponsor
• Described in the Therapeutic Goods Act 1989
• Essentially – the person responsible for the import into, export from, or
supply of a medical device within, Australia.
• Must be an Australian-based entity
• Includes healthcare professionals
• Has regulatory obligations:
– Relationship with manufacturer (can access
conformity assessment and certification
documents).
– Including the device in the Australian Register of
Therapeutic Goods (ARTG).
– Reporting adverse events.
– Meeting advertising requirements. 13Excluded goods
Some products are excluded from the therapeutic goods regulatory
system
• Primarily under the Therapeutic Goods (Excluded Goods)
Determination 2018
Current exemption:
• household and personal aids, or furniture and
utensils, for people with disabilities
14Changes for assistive technology
Proposed change:
• Assistive technology products intended by the manufacturer
to maintain or improve functional capacity of persons with
disability to undertake activities of daily living in settings
other than health care settings.
• Must be:
– Low risk (Class I, non-sterile, non-measuring)
– would not pose a risk of harm that requires medical
attention in circumstances where it malfunctions or
deteriorates when used as intended
Example - not weight bearing (falls can cause
significant injury)
15Examples
Device: prefabricated ankle foot orthosis (AFO)
Orthotist/prosthetist: Makes minor adjustments
to fit the device to the client.
Regulatory status: The manufacturer is the legal
entity responsible for manufacturing the device.
An Australian-based legal entity must include the device in the
ARTG before it can be imported and/or supplied.
Providing the orthotist/prosthetist procures the device from a
sponsor who has included the device in the ARTG, they have no
further regulatory obligations.
16Examples – continued Device: ankle foot orthosis (AFO) Orthotist/prosthetist: prescribes, designs and manufactures. Regulatory status: The orthotist/prosthetist is both manufacturer and sponsor of the device (unless you have an agent/representative). Regulatory obligations: • Ensure the device meets the Essential Principles • Patient-matched: Include the device in the ARTG • Custom-made: Annual reporting, record-keeping, etc 17
Examples – continued Device: ankle foot orthosis (AFO) Orthotist/prosthetist: prescribes and designs, AFO is manufactured by a third party. Regulatory status: The orthotist/prosthetist is still both manufacturer and sponsor of the device (unless you have an agent/representative). Regulatory obligations: • Ensure the device meets the Essential Principles • Patient-matched: Include the device in the ARTG • Custom-made: Annual reporting, record-keeping, etc 18
Componentry
Socket – designed and manufactured to
match the patient by the orthotist /
prosthetist
Knee – supplied as an off the shelf part
Pylon – supplied off the shelf and
intended by the manufacturer to be
modified by the orthotist/prosthetist
Foot – off the shelf or designed and
manufactured to match the patient
19Componentry continued
1. Components supplied off the shelf
are included in the ARTG by
someone else
Orthotist/prosthetist: includes the
socket only in the ARTG.
2. Components supplied off the shelf
are not included in the ARTG by
someone else
Orthotist/Prosthetist: includes the
entire transfemoral prosthesis in the
ARTG.
20Important dates – what to do
• Read the personalised medical devices guidance
• Take the stakeholder survey
• Register for transition by 25 August 2021
• For custom-made devices – submit your
first annual report by 1 October 2021
• For patient-matched – submit your
application for inclusion/reclassification
by 1 November 2024
21Contacts
• Email us: devices@health.gov.au with “SUBSCRIBE PMD” in the subject
line to receive information as it becomes available, updates and reminders
• Medical devices information unit
o 1800 14 11 44
o devices@tga.gov.au
• SME Assist
o www.tga.gov.au/sme-assist
• Regulatory affairs consultants
o https://www.tga.gov.au/regulatory-affairs-consultants
22Resources
https://www.tga.gov.au/publication/medical-
Medical device inclusion process guidance device-inclusion-process
https://www.tga.gov.au/form/essential-
Essential principles checklist principles-checklist-medical-devices
https://www.tga.gov.au/form/declaration-
Declaration of conformity templates conformity-templates-ivds
https://www.tga.gov.au/comparable-
Comparable overseas regulators overseas-regulators-medical-device-
applications
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