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Presentation: Session 4: Annual reports

Workshop: Medical devices: how to stay included

24 August 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: Catherine Looram
  • Presented at: Workshop: Medical devices: how to stay included
  • Presentation date: Workshops were held on 19 May 2016, 2 June 2016, 23-24 June 2016, 21 July 2016 and 27 July 2016
  • Presentation summary: This presentation discusses the requirements and importance of annual reports including information that is required by the TGA and recognising avoidable errors when writing an annual report.

Transcript

Medical Devices: how to stay included

Annual Reports

Catherine Looram
Post-Market Investigator, Device Vigilance and Monitoring Section
Medical Devices Branch, TGA

Medical Devices: how to stay included Workshop

Slide 1 - Learning outcomes

At the end of this session it is envisaged that you will be able to:

  • Understand the requirements and importance of why annual reports need to be provided to the TGA
  • Identify the information that is required, by the TGA, in the annual report
  • Recognise avoidable errors in annual reporting to the TGA

Slide 2 - Overview

  • Who
  • When
  • Why
  • What
  • How
  • Specific to orthopaedic implants that have transitioned
  • Important points to remember
  • Key messages
  • Learning outcomes
  • Further information

Slide 3 - Who

  • Sponsors will be required to submit three annual reports to the TGA following inclusion for higher risk medical devices
  • TGA reviews the information provided for any safety signals

Slide 4 - When to provide annual reports and timelines

  • Annual reports are due on 1 October each year
  • Reports should be for the period 1 July of the previous year to 30 June of the current year
  • Reports should be submitted for devices that were included in the ARTG within the last 3 years prior to the current reporting year
  • The first report following the date of inclusion in the ARTG must be for a period of at least 6 months but no longer than 18 months
    • If the device is included in the ARTG 6 months before 1 January, the annual report is due in October of that year for information from 1 July of the preceding year to 30 June
    • If the device is included in the ARTG after the 1 January, the annual report will not be required until October the following year

Slide 5 - Why do we conduct annual reporting?

  • To ensure that high risk devices new to the Australian market are continuing to meet the essential principles for safety and performance.
  • To ensure that the sponsor and manufacturer’s post-market surveillance system is functioning sufficiently to detect any issues as early as possible.

Slide 6 - What is annual reporting?

  • The TGA requests information about high risk devices every year for the first 3 years after inclusion in the ARTG
  • The devices subject to annual reporting are as follows:
    • AIMD
    • Class III
    • Implantable Class IIb
    • Class 4 IVDs
  • The sponsor will be required to provide, number of devices supplied, complaint and adverse event data

Slide 7 - What information is required for annual reporting

  • The information that the sponsor/manufacturer should include in the annual report for each applicable ARTG entry is as follows:
    • Product name
    • Model no(s) for each respective ARTG entry
    • Number supplied in Australia (Note - if Australian distribution is 0, data must still be provided regarding overseas distribution, complaints and adverse events)
    • Number supplied worldwide
    • Number of complaints in Australia and worldwide
    • Number of adverse events in Australia and worldwide
    • The rate of complaints and adverse events in Australia and worldwide
    • Device Incident Report (DIR) number of any adverse events reported to the TGA
    • Details of any regulatory/corrective action/notification by the manufacturer

Slide 8 - What happens to annual reports?

  • Reports are treated as confidential
  • The annual reports are reviewed by the TGA
  • Any issues arising will be discussed with the sponsor
    • The TGA investigator contacts the sponsor and the reporter and works with them to resolve any issues
    • All reports are entered into the TGA’s record keeping system and referred to during the review if the current report is the second or third report for that device

Slide 9 - How to provide the information for annual reporting

  • Present the information in a clear and logical manner
  • Present the information in a table format
  • Provide the information electronically

Slide 10 - An example of how information for annual reporting might be presented

ARTG # Product name Model # # Supplied Australia # Supplied world wide # of Complaints Australia/ww # of Adverse events Australia/ww
123456 Knee prosthesis - femoral component ABC 123 200 8000 32/235 2/58

Slide 11 - An example of how information for annual reporting might be presented

Type of adverse event and/or complaints Number Percentage in Australia Percentage world wide TGA DIR # Regulatory action
Adverse Events
loosening 2 0.025% 0.058% DIR 12345 Nil

Slide 12 - Specific to orthopaedic implant prosthesis that have transitioned

  • For orthopaedic implant prostheses that have been re-classified from Class IIb to Class III medical devices, information will be required on an annual basis for a minimum of 3 years if:
    • The device was subject to a TGA application audit based on the revision rate when the device transitioned from Class IIb to Class III; and/or
    • No devices were supplied to the Australian marketplace before 30 June 2012; and/or
    • The reporting period has not ended
  • Information is NOT required if the prescribed reporting period has ended
  • If the prescribing reporting period has ended the sponsor needs to indicate this and, in the report, reference the old Class IIb ARTG entry which relates to the new Class III ARTG entry

Slide 13 - Orthopaedic implant transition from Class IIb to Class III

Process diagram - see text version

Text version

  1. Did you have a Class IIb ARTG entry? If Yes, go to 2.
  2. Was a reclassification application submitted between 1 July 2012 - 30 June 2015? If Yes, go to 3.
  3. Was the application selected for audit based on revision rate and/or no devices supplied in Australia prior to 30 June 2012? If Yes, go to 4.
  4. Has the device been included in the ARTG as a Class III?
    • If Yes, A minimum of 3 annual reports are required as a Class III ARTG entry
    • If No, Device is not included in ARTG

Slide 14 - Orthopaedic implant transition from Class IIb to Class III

Process diagram - see text version

Text version

  1. Did you have a Class IIb ARTG entry? If Yes, go to 2.
  2. Was a reclassification application submitted between 1 July 2012 - 30 June 2015? If Yes, go to 3.
  3. Was the application selected for audit based on revision rate and/or no devices supplied in Australia prior to 30 June 2012? If No, go to 4.
  4. Has the device been included in the ARTG as a Class III? If Yes, go to 5
  5. Has the prescribed reporting period ended for the old Class IIb ARTG entry? If No, go to 6.
  6. Provide a combined total of 3 annual reports between the old Class IIb and the new Class III ARTG entries.
  7. Advise TGA of old Class IIb ARTG number and related new Class III ARTG number.

Slide 15 - Orthopaedic implant transition from Class IIb to Class III

Process diagram - see text version

Text version

  1. Did you have a Class IIb ARTG entry? If Yes, go to 2.
  2. Was a reclassification application submitted between 1 July 2012 - 30 June 2015? If Yes, go to 3.
  3. Was the application selected for audit based on revision rate and/or no devices supplied in Australia prior to 30 June 2012? If No, go to 4.
  4. Has the device been included in the ARTG as a Class III? If Yes, go to 5.
  5. Has the prescribed reporting period ended for the old Class IIb ARTG entry? If Yes, go to 6.
  6. Annual reporting information is not required
  7. Advise TGA of old Class IIb ARTG number and related new Class III ARTG number

Slide 16 - Orthopaedic implant transition from Class IIb to Class III

Process diagram - see text version

Text version

  1. Did you have a Class IIb ARTG entry? If Yes, go to 2.
  2. Was a reclassification application submitted between 1 July 2012 - 30 June 2015? If Yes, go to 3.
  3. Was the application selected for audit based on revision rate and/or no devices supplied in Australia prior to 30 June 2012? If No, go to 4.
  4. Has the device been included in the ARTG as a Class III? If No, go to 5.
  5. Device is not included in the ARTG.

Slide 17 - Orthopaedic implant transition from Class IIb to Class III

Process diagram - see text version

Text version

  1. Did you have a Class IIb ARTG entry? If Yes, go to 2.
  2. Was a reclassification application submitted between 1 July 2012 - 30 June 2015? If Yes, go to 3.
  3. Was the application selected for audit based on revision rate and/or no devices supplied in Australia prior to 30 June 2012?
    • If Yes: Has the device been included in the ARTG as a Class III?
      • If Yes, A minimum of 3 annual reports are required as a Class III ARTG entry
      • If No, Device is not included in ARTG
      End process
    • If No, go to 4.
  4. Has the device been included in the ARTG as a Class III?
    • If Yes go to 5.
    • If No, Device is not included in ARTG. End process.
  5. Has the prescribed reporting period ended for the old Class IIb ARTG entry?
    • If Yes, Annual reporting information is not required. Go to 7.
    • If No to to 6.
  6. Provide a combined total of 3 annual reports between the old Class IIb and the new Class III ARTG entries
  7. Advise TGA of old Class IIb ARTG number and related new Class III ARTG number

Slide 18 - Example - Orthopaedic implant that has transitioned

TGA application audit based on the revision rate

  • Annual report information will be required annually for a period of 3 years for the Class III device for the following:
    • An Orthopaedic Hip Stem used in a total conventional hip replacement was subject to a TGA application audit based on the revision rate of 2 Revisions/100 OBS Years when the device was transitioned from Class IIb to Class III (the NJRR acceptable revision rate 0.8 Revisions/100 OBS Years)

Slide 19 - Example - Orthopaedic implant that has transitioned

No devices were supplied to the Australian marketplace before 30 June 2012

  • Annual report information will be required annually for a period of 3 years for the Class III device for the following:
    • A shoulder joint implant where no devices were supplied to the Australian marketplace before 30 June 2012

https://en.wikipedia.org/wiki/Shoulder_replacement

Slide 20 - Example - Orthopaedic implant that has transitioned

The reporting period has not ended

  • Annual report information will be required for a combined total of 3 annual reports between the old Class IIb ARTG entry and the related new Class III ARTG entry for the following:
    • A knee joint implant that has transitioned from Class IIb to Class III, it has not been selected for audit based on revision rate and devices have been supplied to the Australian market place before 30 June 2012
    • Two annual reports have previously been provided for the old Class IIb ARTG entry
    • One further annual report is required for the new Class III ARTG entry

Slide 21 - Important points to remember

  • Provide all the information requested (and just the information requested) within the required timeframes
  • Ensure the correct ARTG entry number corresponds to the device
  • Proof reading - check accuracy, be careful of cut and paste
  • Lack of information or relevancy - ensure all the information is made available, accurate and relevant to the request and device
  • If the requested annual reports are not provided the TGA can take further regulatory action, such as cancelling the ARTG entries from the register

Slide 22 - Key messages

  • Be prepared:
    • Collect feedback
    • Analyse trends
    • Regularly review
    • Know what devices you supply and their corresponding ARTG number
  • Be timely - the reports are all due on 1 October of each year. Don't rely on TGA reminders
  • Provide an argument for the notion that the figures demonstrate acceptable safety and performance
  • Learn from the information that you are submitting

Slide 23 - Learning outcomes

At the end of this session it is envisaged that you will be able to:

  • Understand the requirements and importance of why annual reports need to be provided to the TGA
  • Identify the information that is required, by the TGA, in the annual report
  • Recognise avoidable errors in annual reporting to the TGA

Slide 24 - Further Information

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