You are here

Half yearly performance report - January to June 2015

16 December 2015

Book pagination

6. Medical devices

The regulatory framework for medical devices spans the life cycle for these products, including:

  • Conformity assessment: The systematic examination by the manufacturer to determine that a medical device is safe and performs as intended and, therefore, conforms to the Essential Requirements. Certification of the manufacturer's conformity assessment procedure may (and in some cases must) be undertaken by TGA, or the TGA may recognise conformity assessment certification from European notified bodies.
  • Inclusion on the ARTG: Medical devices cannot be imported, supplied in, or exported from Australia unless they are included in the ARTG (unless a valid exemption applies).1 A sponsor can apply to include a medical device in the ARTG if the device complies with the Essential Principles and appropriate conformity assessment procedures have been applied to the device (typically demonstrated through conformity assessment certification).
  • Post-market monitoring: Once a medical device has been included in the ARTG the device must continue to meet all the regulatory, safety and performance requirements and standards that were required for the approval.

6.1 Conformity assessment

6.1.1 Applications

Table 25: Number of conformity assessment applications (medical devices including IVDs)
2014 2015
Jan-Jun Jul-Dec Jan-Jun
Applications received 98 112 81
Applications on hand 162 115 123
Applications completed 131 125 83

6.1.2 Outcomes

Figure 4: Outcomes of conformity assessment applications

The number of applications approved, rejected and withdrawn/lapsed for conformity assessment applications for the periods Jan-Jun 2014; Jul-Dec 2014 and Jan-Jun 2015.

Text version of figure 4
  • Jan-Jun 2014
    • Approved - under 120
    • Rejected - under 140
    • Withdrawn/Lapsed - over 160
  • Jul-Dec 2014
    • Approved - over 80
    • Rejected - over 80
    • Withdrawn/Lapsed - under 120
  • Jan-Jun 2015
    • Approved - over 60
    • Rejected - over 60
    • Withdrawn/Lapsed - over 80

6.1.3 Processing times

The TGA is required to complete conformity assessment applications within 255 working days.

Processing time is defined as the number of working days from the acceptance of the application until formal notification of decision. Under the Therapeutic Goods Regulations 1990, working days exclude public holidays and weekends. Processing time excludes time where the TGA was unable to progress the application until the sponsor provided additional information unless otherwise specified.

Table 26: Percentage of applications completed within target processing time
2014 2015
Jan-Jun Jul-Dec Jan-Jun
New devices 100% 100% 100%
Mean TGA processing times 119 137 122
Median TGA processing times 108 195 151
Changes or recertification 98% 100% 100%
Mean TGA processing times 86 93 77
Median TGA processing times 54 79 48

6.2 Inclusion of medical devices (including IVDs)

6.2.1 Applications

Table 27: Applications for inclusion - medical devices (including IVDs)
2014 2015
Jan-Jun Jul-Dec Jan-Jun
Class 1 medical devicesa
Applications received 1405 1302 1201
Applications completed 1397 1303 1194
Class 1 measuring medical devices
Applications received 24 33 41
Applications completed 27 30 44
Applications on handb 7 3 4
Class 1 sterile medical devices
Applications received 108 131 118
Applications completed 115 135 130
Applications on handb 42 7 7
Class IIa medical devices
Applications received 676 679 605
Applications completed 675 742 640
Applications on handb 226 58 85
Class IIb medical devices
Applications received 350 357 411
Applications completed 339 375 385
Applications on handb 130 52 61
Class III medical devices
Applications received 219 243 182
Applications completed 262 184 188
Applications on handb 355 218 260
Class III Joint Reclassification medical devicesc
Applications received 150 114 523
Applications completed 329 231 133
Applications on handb 891 252 538
Active Implantable Medical Devices (AIMD)
Applications received 25 37 14
Applications completed 49 42 4
Applications on handb 50 23 51
Class 1 IVDs
Applications received 86 53 103
Applications completed 79 72 86
Applications on handb 8 3 7
Class 2 IVDs
Applications received 145 77 169
Applications completed 127 104 123
Applications on handb 28 5 30
Class 3 IVDs
Applications received 108 55 168
Applications completed 90 74 109
Applications on handb 34 15 22
Class 4 IVDs
Applications received 24 14 43
Applications completed 23 15 40
Applications on handb 1 0 0
  1. As Class I medical device applications are automatically included, there are no applications for this classification of device 'on hand'. Differences in the number received and finalised relate to those applications received on the last day of the reporting period.
  2. Applications on hand - figures shown are correct as of the date when the data was extracted
  3. The transition period for joint reclassification finished on 30 June 2015. A large number of applications were received at the end of this transition period, late in the January to June 2015 reporting period. As the transition period has now finished Class III joint reclassification applications will be rolled into the general Class III applications in future reports.

6.2.2 Outcomes

Class I automatically included medical devices are not counted in the outcomes for inclusion applications as these applications cannot be rejected.

Table 28: Outcomes of medical device applications by classification for January to June 2015
Number of applications
Device Classification Approved/Accepted Rejected/Lapsed Withdrawn
Class 1 1194 N/A N/A
Class 1 Measurement 36 2 6
Class 1 Sterile 124 2 4
Class IIa 595 6 39
Class IIb 362 5 18
Class III 143 36 9
Class III Reclassification 119 1 13
AIMD 3 1 0
Class 1 IVD 85 0 1
Class 2 IVD 115 0 8
Class 3 IVD 92 0 17
Class 4 IVD 38 0 2

6.2.3 Processing times

The agreed target time for level 1 application audits is 30 TGA work days and for level 2 application audits is 60 TGA work days (reflected in 'TGA days'). This does not include the period the TGA is waiting for information or payment of fees (reflected in 'sponsor days').

Table 29: Processing times for medical devices application audits (including IVDs) for January to June 2015
Number of applications Mean Audit Processing Time
Sponsor days TGA daysb
Medical devices
Applications completed without audit 1136a
Non-compulsory auditc 220 28 47
Level 1 compulsory audit 11 17 5
Level 2 compulsory audit 155 42 82
IVDs
Applications completed without audit 204a
IVD non-compulsory audit 4 36 11
IVD compulsory audit 71 22 14
  1. These figures do not include applications for Class I and Class 1 IVD auto-included devices. These applications are complete within 24 hours.
  2. TGA time starts when the application is selected for audit, and it does not include public holidays and weekends, and the time when the TGA waits for information or payment from the sponsor.
  3. Non-compulsory audit - estimate for the audit processing time does not include applications for reclassification of join replacement medical devices received during transitional period (Class III Joint Reclassification medical devices), and applications supported by EC certificates issued by certain notified bodies (for details see Increased application audit requirements for some medical devices applications).

6.3 Post-market monitoring

6.3.1 Automatically included entries

As Class I medical devices are automatically included without review by the TGA, post-market regulatory reviews are undertaken to ensure Class I are correctly included. This includes restricted word reviews, where applications for Class I devices are identified by the use of specific words indicative of risk or issues relating to the inclusion of the device, and targeted reviews that are initiated on a case by case basis (target reviews are conducted in relation to devices of any Class).

Table 30: Restricted word and targeted Class I medical devices reviews
2014 2015
Jan-Jun Jul-Dec Jan-Jun
Restricted word reviews
Reviews completed 17 7 0
Reviews commenced 17 4 0
Reviews on hand 13 0 0
Targeted reviews
Reviews completed 114 94 63
Reviews commenced 136 33 46
Reviews on hand 413 67 50

6.3.2 Post-market reviews

TGA also undertakes a range of post market reviews for devices above Class I.

Table 31: Medical device targeted reviews
2014 2015
Jan-Jun Jul-Dec Jan-Jun
Post market reviews
Reviews commenced - number of ARTG entries 106 40 58
Reviews completed - number of ARTG entries 75 75 44
Reviews on hand - number of ARTG entries 121 87 96

6.3.3 Medical device incident reports

Processing time is defined as the number of working days from the receipt of the notification until the incident has been investigated and resolved. Under the Therapeutic Goods Regulations 1990, working days exclude public holidays and weekends.

The target timeframe for processing of medical device incident reports is 90 working days.

Table 32: Number of medical device incident reports and processing times
2014 2015
Jan-Jun Jul-Dec Jan-Jun
Reports received 1498 1662 1575
Reports completed 1578 2641 1499
Reports still in progress 498 169 155
Processing time
Mean TGA processing time 59 19 14
Percentage processed within target timeframe 82% 86% 85%
Table 33: Medical device incident report outcomesa
2014 2015
Jan-Jun Jul-Dec Jan-Jun
Reviewed and used for trend analysis purposes 862 1801 1248
Reviewed, no further action required 583 689 392
Product recall 42 23 39
Recall for product correction 18 5 13
Hazard alert 36 40 20
Product notification 0 1 0
Safety alert 46 11 8
Product enhancement/improvement notice 1 1 1
Instructions for use amended 26 15 11
Referral for post-market review 2 53 22
Referral to TGA Office of Manufacturing Quality 9 1 0
Refer to another TGA Office 35 28 27
Company warned 3 0 2
Product suspended from ARTG 0 0 0
Product cancelled from ARTG 1 1 5
Manufacturing process improvements 42 11 19
Quality system process improvements 5 8 3
Maintenance carried out by the hospital 1 0 0
Change to design 6 11 3
Not device related 9 6 1
Other 97 119 44
  1. Outcomes are not mutually exclusive

Footnote

  1. Exemptions include custom made medical devices, importation of samples, etc.

Book pagination