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Presentation

• Presented by: Dr Lee Walsh
• Presented at: Wearable Technologies Conference, Sydney
• Presentation date: 7 December 2017 (Conference was 7-8 Dec 2017)
• Presentation summary: Complying with Wearable Health Device Regulation
  • Which devices does the TGA regulate?
  • How are devices approved?
  • How does the TGA regulate devices once they are on the market?

Transcript

Show transcript for this slideshow

Complying with Wearable Health Device Regulation

Dr Lee Walsh
Senior Engineer, Biomaterials and Engineering Section
Laboratories Branch

Wearable Technologies Conference, Sydney, 7 December 2017

Slide 1 - Overview of the TGA

• Part of the Australian Government Department of Health
• Administers the Therapeutic Goods Act 1989
• Main offices in Canberra – satellite offices in Sydney, Melbourne, Adelaide and Brisbane
• Operations cost recovered from industry
• Mission: To safeguard and enhance the health of the Australian community through the effective and timely regulation of therapeutic goods

Slide 2 - Overview of the TGA – What we do

• Evaluate therapeutic goods before they are supplied
• Focus on safety, quality and performance
• Monitor products once they are on the market
• Allow for access to unapproved goods in certain circumstances
• Provide input to therapeutic goods standards


• We do not make decisions based on value for money or make decisions about which products receive Government subsidy

Slide 3 - Who does this work?

Approximately 750 staff made up of:

• Biomedical scientists
• Pharmacists
• Nutritionists
• Engineers
• Physiotherapists
• Toxicologists
• Scientists
• Medical officers
• Lawyers
• Administrative staff

Slide 4 - The legislation

The TGA makes decisions based upon:

• Therapeutic Goods Act 1989
• Therapeutic Goods Regulations 1990
• Therapeutic Good (Medical Devices) Regulations 2002

Available on www.legislation.gov.au

Legislative instruments

• Therapeutics Goods Orders (TGO)
• Excluded Goods Orders
• Medical Device Standards Orders (MDSO)
• Conformity Assessment Standards Orders (CASO)

Available on www.tga.gov.au

Slide 5 - Is my wearable device regulated by the TGA?

41BD What is a medical device

1. A medical device is:

(a) any instrument, apparatus, appliance, material or other article (whether used alone or in combination, and including the software necessary for its proper application) intended, by the person under whose name it is or is to be supplied, to be used for human beings for the purpose of one or more of the following:

1. diagnosis, prevention, monitoring, treatment or alleviation of disease;
2. diagnosis, monitoring, treatment, alleviation of or compensation for an injury or disability;
3. investigation, replacement or modification of the anatomy or of a physiological process;
4. control of conception;

and that does not achieve its principal intended action in or on the human body by pharmacological, immunological or metabolic means, but that may be assisted in its function by such means; or

(aa) any instrument, apparatus, appliance, material or other article specified under subsection (2A); or

(ab) any instrument, apparatus, appliance, material or other article that is included in a class of instruments, apparatus, appliances, materials or other articles specified under subsection (2B); or

(b) an accessory to an instrument, apparatus, appliance, material or other article covered by paragraph (a), (aa) or (ab).

(2A) The Secretary may, by notice published in the Gazette or on the Department's website, specify a particular instrument, apparatus, appliance, material or other article for the purposes of paragraph (1)(aa). The notice is not a legislative instrument.

(2B) The Secretary may, by legislative instrument, specify a particular class of instruments, apparatus, appliances, materials or other articles for the purposes of paragraph (1)(ab).

2. For the purposes of paragraph (1)(a), the purpose for which an instrument, apparatus, appliance, material or other article (the main equipment) is to be used is to be ascertained from the information supplied, by the person under whose name the main equipment is or is to be supplied, on or in any one or more of the following:
   1. the labelling on the main equipment;
   2. the instructions for using the main equipment;
   3. any advertising material relating to the main equipment;
   4. technical documentation describing the mechanism of action of the main equipment.

3. The Secretary may, by order published in the Gazette or on the Department's website, declare that a particular instrument, apparatus, appliance, material or other article, or that a particular class of instruments, apparatus, appliances, materials or other articles, are not, for the purposes of this Act, medical devices.

Is it a medical device as defined by the TG Act?

Slide 6 - My tech is a medical device, what now?

Australian regulatory guidelines for medical devices (ARGMD)

• Available on www.tga.gov.au
• Currently under review

In summary:

• Australian Register of Therapeutic Goods (ARTG)
• Risk based regulation
• Classification
• Essential Principles
• Quality System
• Evidence

Slide 7 - Risk based regulation and classification

Higher risk devices receive higher scrutiny

Therapeutic Goods (Medical Device) regulations 2002, Schedule 2

Slide 8 - Inclusion on the ARTG

Text version of OTC application placement flowchart

This text representation of this flowchart is provided as a list with numbered steps.

1. Sponsor (go to step 2 or 3)
2. Submit application for class 1 IVD or Class 1 (not IVD): Auto inclusion - end flowchart
3. Manufacturer Evidence (Except for Class 1 IVD/Class1): Submit application for ARTG inclusion
4. Pay application fee
5. Application effective?
   1. YES: Go to step 6
   2. NO: End flow chart
6. Audit?
   1. YES: Go to step 7
   2. NO: Go to step 12
7. TGA requires information and audit fee (if applicable)
8. Application lapses if fee not paid or information not provided
9. Audit assessment

Slide 9 - My device is included in the ARTG, am I done?

Incident Report Investigation Scheme (IRIS)

• Sponsor must report the details of events associated with their devices that have, or could have resulted in serious injury or death – TG (MD) Regs 2002

Text version of Incident Report Investigation Scheme (IRIS) flowchart

This text representation of the IRIS flowchart is provided as a list with numbered steps.

1. Assest Risk (go to step 2)
2. Investigate (go to step 3 or 7)
3. Referral and Laboratory testing (leads to product improvement)
4. Regulatory action (go to step 5 or 6)
5. Other action (leads to product improvement)
6. Recall, Safety alert, Report, Cancel or suspend (each of these actions leads to step 7)
7. Data logged for ongoing monitoring

Each step leads to overall Product improvement

Slide 10 - Other considerations

TGA can approve the supply of unregistered therapeutic goods

• Authorised prescribers
• Special access scheme
• Clinical trials
• Personal importation
• See www.tga.gov.au

There are penalties for (TG Act 1989, Part 4-11):

• Supplying a medical device that does not comply with the Essential Principles
• Not applying conformity assessment procedures
• Supplying a medical device that is not included in the register

There are advertising and labelling requirements (TG Act 1989, Chapter 5)

Slide 11 - The Essential Principles

Therapeutic Goods (Medical Devices) Regulations 2002, Schedule 1

• A legislated requirement for medical devices (TG Act 1989, Section 41CA)
• Used in pre-market evaluations
• Used in post market monitoring
• Standards may or may not be sufficient to demonstrate compliance

TGA assessors will assess your device against the Essential Principles

You should assess your device against the Essential Principles

You should consider the Essential Principles at every stage of you medical device’s life

Slide 12 - The Essential Principles

Therapeutic Goods (Medical Devices) Regulations 2002, Schedule 1

General principles

1. Use of medical devices not to compromise health and safety
2. Design and construction of medical devices to conform to safety principles
3. Medical devices to be suitable for intended purpose
4. Long-term safety
5. Medical devices not to be adversely affected by transport or storage
6. Benefits of medical devices to outweigh any side effects

Principles about design and construction

7. Chemical, physical and biological properties
8. Infection and microbial contamination
9. Construction and environmental properties
10. Medical devices with a measuring function
11. Protection against radiation
12. Medical devices connected to or equipped with an energy source
13. Information to be provided with medical devices
14. Clinical evidence
15. Principles applying to IVD medical devices

www.legislation.gov.au

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