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TGA presentation: Australian Dental Industry Association custom-made medical devices workshop, 12-13 July 2016

Presentation: Custom-made medical devices: Information for the dental industry

15 July 2016

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These presentation papers are provided on the TGA's website solely for the purpose of indicating or suggesting what TGA representatives spoke about to the various conferences and seminars to which it relates. The papers are not legislative in nature and should not be taken to be statements of any law or policy in any way.

The Australian Government Department of Health (of which the TGA is a part) advises that (a) the presentation papers should not be relied upon in any way as representing a comprehensive description of regulatory requirements, and (b) cannot guarantee, and assumes no legal liability or responsibility for, the accuracy, currency or completeness of the information contained in the presentation paper.

Presentation

  • Presented by: Valerie Mercer, Director Medical Devices Information and Education, Medical Devices Branch, Therapeutic Goods Administration
  • Presented at: Australian Dental Industry Association (ADIA) Custom-made medical devices workshop
  • Presentation date: 12-13 July 2016
  • Presentation summary: Custom-made medical devices. Information for the dental industry on the legislative framework and regulatory obligations pre and post market.

Transcript

Custom-made medical devices: Information for the dental industry

Valerie Mercer
Director Medical Devices Information and Education
Medical Devices Branch
Therapeutic Goods Administration

ADIA industry briefing 12-13 July 2016

Slide 1 - Discussion topics

  • Legislative framework
  • What is custom-made?
  • Notifying TGA
  • Regulatory obligations
    • pre-market
    • post-market

Slide 2 - Regulatory framework

Commonwealth legislation

Slide 3 - Therapeutic Goods Act 1989

Contents page: Chapter 4 - Medical devices

For detailed information, please refer to Chapter 4 - Medical devices in the Therapeutic Goods Act 1989.

Slide 4 - Therapeutic Goods (Medical Devices) Regulations 2002

Contents page: Therapeutic Goods (Medical Devices) Regulations 2002 highlighting:

  • Schedule 1 - Essential principles
  • Schedule 3 - Conformity assessment procedures
  • Schedule 4 - Exempt devices

For further details, please refer to the Therapeutic Goods (Medical Devices) Regulations 2002.

Slide 5 - Definitions

Medical device

  • s41BD of the Act defines a medical device as ...
    • any instrument, apparatus, appliance, material or other article ... including the software ... human beings ...
      • diagnosis, prevention, monitoring, treatment or alleviation of disease
      • diagnosis, monitoring, treatment, alleviation of or compensation for an injury or disability
      • investigation, replacement or modification of the anatomy or of a physiological process
      • not pharmacological, immunological or metabolic means

For more context of the dot points view section 41BD of the Therapeutic Goods Act 1989.

Slide 6 - Definitions

Custom-made medical device

  • the Regulations define a custom-made medical device as ...
    • ... request by a health professional ... design characteristics or construction ...
    • ... used only in relation to a particular individual ...
    • ... used by the health professional to meet special needs ...
  • examples relevant to the dental industry may include:
    • crowns
    • bridges
    • dentures
    • specialised instruments

For more context of the dot points view the Therapeutic Goods (Medical Devices) Regulations 2002.

Slide 7 - 'Customised' does not equal a custom-made medical device

  • an existing medical device that is adapted, altered, fashioned, modified or 'customised' to fit a patient is NOT a custom-made medical device
  • for example, a preformed permanent dental crown that may require minimal fashioning in situ during restorative work is not a custom-made medical device
  • devices already included on the ARTG that are combined and adapted for an individual (provided the devices are used as intended by the manufacturer/IFUs) are not custom-made medical devices (orthodontic braces)

Slide 8 - Definitions

Manufacturer

  • s41BG of the Act defines a manufacturer as ...
    • ... person who is responsible for the design, production, packaging and labelling of the device before it is supplied under the person's name ...

For more context of the dot point view the Therapeutic Goods Act 1989.

Slide 9 - Definitions

Sponsor

  • s3 of the Act defines a sponsor as ...
    • ... exports ... from Australia ...
    • ... imports ... into Australia ...
    • ... a person who, in Australia, manufactures the goods, or arranges for another person to manufacture the goods, for supply (whether in Australia or elsewhere) ...
  • sometimes the sponsor and the manufacturer are the same entity e.g. a dental laboratory that supplies their products directly to dental professionals
  • dentists and allied oral healthcare providers can import custom-made devices from overseas, but in doing so they become the sponsor and acquire obligations

Slide 10 - Definitions

Kinds of devices

  • s41BE of the Act defines kinds of medical devices as ...
    • ... sponsor ...
    • ... manufacturer ...
    • ... code ...
    • ... classification ...
  • TGA needs to be notified of each kind of device
  • TGA does not need to be notified about each individual device being made for individual patients

Slide 11 - Kinds of medical devices - examples

Example 1

Dentist (sponsor) imports polymer dental bridges manufactured by Manufacturer A in China:

  • same sponsor
  • same manufacturer
  • same GMDN code
  • same classification

Therefore same kind of medical device and only one notification to TGA required.

Do not need to notify TGA for each patient receiving a custom-made medical device of this kind.

Example 2

Dentist (sponsor) imports polymer dental bridges manufactured by Manufacturer A in China and Manufacturer B in Germany:

  • same sponsor
  • different manufacturers
  • same GMDN code
  • same classification

Therefore not the same kind of medical device and separate notifications required for each kind.

Again, do not need to notify TGA for each patient, only the kind of device.

Slide 12 - Regulatory obligations

Who has obligations?

  • both the manufacturer and the sponsor have obligations
  • requirements to:
    • meet the essential principles (EPs) - this demonstrates the quality, safety and performance of the device
    • apply a conformity assessment procedure - this generates evidence that the device complies with the EPs
    • notify the TGA
    • comply with advertising requirements
    • report adverse events

But aren't custom-made devices 'exempt'?

  • exempt from ARTG inclusion only
  • all other obligations still apply

Slide 13 - Requirement to notify TGA

  • since 2002, Australian manufacturers and sponsors importing custom-made medical devices into Australia have been required to notify TGA about certain details, e.g. name and business address, description of the 'kind of device'
  • in February 2016 the regulations were amended to introduce a two month timeframe for notification to the TGA
  • details in Regulation 10.3

For more information on 10.3 Custom-made medical devices, view the Therapeutic Goods (Medical Devices) Regulations 2002.

How to notify ...

  • simple web-based notification form
  • quick and easy to complete and submit
  • some fields mandatory
  • within 2 months of the device being manufactured in Australia or first imported into Australia
  • Custom made medical devices

Slide 15 - Custom-made medical devices form

Select manufacturer or sponsor.

In some circumstances this is the same entity. TGA is planning to amend the form so that this option is available.

The first example demonstrates how a manufacturer will complete the form, i.e. an Australian manufacturer (manufacturers located overseas are not required to notify TGA - in this instance the obligation to notify is transferred to the Australian sponsor who imports and supplies).

Custom-made medical device form

Slide 16 - Australian manufacturer of a custom-made medical device

The mandatory fields are simple details:

  • Manufacturer's name and business address
  • Sponsor's name and address
  • Brief description of the device
  • Classification of the device

Manufacturer fields

Note that GMDN code is not a mandatory field. Codes are available through GMDN Agency membership (cost involved) or through TGA Business Services (must have client id and mock up an ARTG application).

Other non-mandatory details include contact info (email and phone) which TGA may need to use in case of post-market activities or recalls.

Slide 17 - Submission complete - Custom-made medical devices

This is the page you will see once you have successfully completed a notification.

Submission complete - Custom-made medical devices

You can immediately download a copy of the completed form or have a copy emailed to any address you enter.

Slide 18 - Form submitted

If you nominate to have an emailed version sent to you, this is the email you will receive. Note that the completed form is an attachment.

Form submitted

Slide 19 - Attachment

This is the view you will see once you open the attachment. Again you can save a copy of this if you choose.

Attachment first page

Attachment second page

Slide 20 - Sponsor - Additional fields to be completed

The form has some additional fields for completion if you are a sponsor.

You will need to include the manufacturer's details (often an overseas manufacturer, but may be an Australian manufacturer) as well as your own details as the sponsor.

Just like we saw when an Australian manufacturer completes the notification, the sponsor receives the same option to download a copy of the completed form or receive it as an attachment to an email.

Sponsor fields to be completed

Slide 21 - Other regulatory obligations

Essential Principles

  • Regulations Schedule 1, Part 1 (general principles) and Part 2 (principles about design and construction)
  • manufacturer must meet the applicable essential principles
  • sponsor must ensure device meets applicable essential principles
  • some EPs may not apply to the device (e.g. if the custom-made medical device is not supplied in a sterile state, the essential principles regarding sterility are not relevant and will not need to be met)
  • some essential principles apply only to custom-made medical devices:
    • information that must be provided with a medical device - an indication that the device has been custom-made for a particular individual or health professional and is intended for use only by that individual or health professional must be provided with a custom-made medical device
    • instructions for use (if required) must include an indication that the device has been custom-made for a particular individual or health professional and is intended for use only by that individual or health professional
  • there is an 'essential principles checklist' on TGA's website which may be helpful (not mandatory)

Slide 22 - Other regulatory obligations

Conformity assessment procedures

The manufacturer is required to:

  • prepare and sign a written statement containing specific information (detailed in the Regs sched 3 item 7.2)
  • prepare documentation relating to the design, production and intended performance of the device (and keep the documentation up-to-date)
  • take all measures necessary to ensure that the manufacturing process results in the device complying with the documentation mentioned above
  • notify the TGA as soon as practicable of certain events that might lead (or might have led) to the death or serious deterioration of the state of health of the patient or user, or caused the manufacturer to recover a device that has been distributed. Examples of these events include malfunction, deterioration and inadequacy in the design, production, labelling or instructions for use.

The sponsor is required to ensure that the manufacturer has applied the conformity assessment procedures.

Slide 23 - About the 'statement'

Details to be included:

  • name and business address of manufacturer
  • information to identify the device
  • statement that manufacturer intends device to be used only for a particular individual or health professional
  • name of the individual or health professional
  • name and business address of health professional that provided device specifications
  • particular design characteristics or construction provided by health professional
  • a statement that the device complies with the applicable essential principles, or a statement explaining which essential principles it does not comply with and reasons for the non-compliance

Statement to be signed and dated by an authorised person (from the manufacturer) and kept up-to-date

Slide 24 - Therapeutic Goods Advertising Code 2015

General Principles

Section 4 sets out the key requirements including that therapeutic good advertisements "must not":

  • Mislead or be likely to mislead
  • Arouse unrealistic expectations of product effectiveness
  • Lead consumers to self-diagnosing, inappropriately treating or believing they have a serious disease
  • Abuse consumers' trust or exploit their lack of knowledge
  • Encourage inappropriate or excessive use
  • Claim that a good is guaranteed, certain, sure cure or that the goods are completely safe or harmless
  • Be directed to minors (subject to exceptions)
  • Therapeutic Goods Advertising Code 2015

Slide 25 - Adverse events

What to report

Please resport adverse events, as well as near misses

What to report

Slide 26 - Summary

  • Both manufacturers and sponsors/suppliers of custom-made medical devices have obligations
  • 'Custom-made' has a specific meaning and is defined in the regulatory framework (not customised/adapted)
  • Custom-made devices have specific requirements for information to be supplied with the device
  • Custom-made devices are exempt from ARTG inclusion, but other obligations still apply
  • Timeframe for notifying TGA of custom-made devices is 2 months
    • from initial manufacture (if manufactured in Australia)
    • from initial importation/supply in Australia (if manufactured overseas)
  • Notifying TGA is only one obligation - others include:
    • device must meet essential principles
    • device must have had conformity assessment procedure applied
    • adverse events must be reported to TGA

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