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Annual performance statistics report: July 2016 to June 2017

12 September 2017

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6. Medical devices

The Medical Devices Regulatory Framework spans the life cycle for these products, including:

  • Conformity assessment: Is the systematic examination by the manufacturer to determine that a medical device is safe and performs as intended and, therefore, conforms to the Essential Principles. Certification of the manufacturer's conformity assessment procedure may (and in some cases must) be undertaken by the TGA, or we 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 on the ARTG or a valid exemption applies, for example custom made medical devices, importation of samples, etc. A sponsor can apply to include a medical device on 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 on 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 27 Number of conformity assessment applications (medical devices including IVDs)
  2015-16 2016-17
July to June
Conformity assessment applications
Applications received 257 242
Applications on hand 178 213
Applications completed 187a 204
  1. Due to a correction in coding, a small variation has occurred to the data.

6.1.2 Outcomes

Table 28 Outcomes of conformity assessment applications
  2015-16 2016-17
July to June
New
Approved 49 37
Rejected 3 1
Withdrawn / Lapsed 23 20
Variation (changes and re-certifications)
Approved 91 124
Rejected 3 2
Withdrawn / Lapsed 18 20
Total 187 204

Table 30 has been broken down into 'New' and 'Variation' assessment application to provide additional transparency and understanding. In reviewing the changes in reporting the final total was increased by one, as per updates to operational data.

6.1.3 Processing times

We are 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 we were unable to progress the application until the sponsor provided additional information unless otherwise specified.

Table 29 TGA processing times for new devices and variations
  2015-16 2016-17
July to June
New devices
Mean TGA processing time (days) 133 129
Median TGA processing time (days) 178 167
Variations (changes and recertifications)
Mean TGA processing time (days) 93 114
Median TGA processing time (days) 71 101

During 2016-17, 100% of conformity assessment applications were completed within 200 working days.

6.2. Inclusion of medical devices (including IVDs)

6.2.1 Applications

Table 30 Applications for inclusion – medical devices (including IVDs)
  2015-16 2016-17
July to June
Class I medical devicesa
Applications received 2,685 2,514
Applications completed 2,690 2,431
Class I measuring medical devices
Applications received 48 51
Applications completed 48 50
Applications on handb 2 4
Class I sterile medical devices
Applications received 257 246
Applications completed 253 255
Applications on handb 11 3
Class IIa medical devices
Applications received 1,178 1,160
Applications completed 1,206 1,178
Applications on handb 58 51
Class IIb medical devices
Applications received 654 666
Applications completed 716 682
Applications on handb 40 34
Class III medical devices
Applications received 344 343
Applications completed 249 471
Applications on handb 313 180
Class III Joint Reclassification medical devicesc
Applications received 0 0
Applications completed 355 203
Applications on handb 294 94
Active Implantable Medical Devices (AIMD)
Applications received 49 48
Applications completed 19 87
Applications on handb 62 23
Class 1 IVDsd
Applications received 92 94
Applications completed 112 91
Applications on handb 1 4
Class 2 IVDs
Applications received 104 96
Applications completed 148 94
Applications on handb 10 12
Class 3 IVDs
Applications received 65 49
Applications completed 131 45
Applications on handb 11 15
Class 4 IVDs
Applications received 25 15
Applications completed 29 15
Applications on handb 0 0
  1. Class I medical devices are automatically included (i.e. these applications are completed within 24 hours). 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 and/or technological errors occurring in the system.
  2. Applications on hand - figures shown are correct as of the date when the data was extracted. There may also be delays between the date of the decision and the time when the system is updated due to administrative and/or technological processes.
  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.
  4. The number of applications for Class 1 IVD includes auto-included devices and applications completed with or without audit.

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 31 Outcomes of medical device applications by classification
  Number of applications
2015-16 2016-17
Device Classification Approved/ Accepted Rejected/ Lapsed Withdrawn Approved/ Accepted Rejected/ Lapsed Withdrawn
Class I 2,690 0 0 2,431 0 0
Class I Measurement 47 0 1 44 2 4
Class I Sterile 234 0 19 248 0 7
Class IIa 1,132 2 72 1,128 6 44
Class IIb 679 1 36 659 3 20
Class III 207 12 30 398 18 55
Class III Reclassification 278 7 70 152 3 48
AIMD 17 0 2 87 0 0
Class 1 IVDa 112 0 0 84 0 7
Class 2 IVDa 136 3 9 71 2 21
Class 3 IVDa 123 1 7 37 0 8
Class 4 IVDa 28 0 1 14 0 1
  1. The IVD transition period ended on 30 June 2015, with a number of applications received late in the transition period. The higher number of applications completed in 2015-16 reflected the end of this transition period.

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 we are waiting for information or payment of fees (reflected in 'sponsor days').

Table 32 Processing times for medical device application audits (including IVDs)
  2015-16 2016-17
Number of applications Sponsor days TGA daysa Number of applications Sponsor days TGA daysa
Mean Processing Time
Medical devices
Applications completed without audit 2,112b     2,105    
Non-compulsory auditc 497 30 43 310 42 55
Level 1 compulsory audit 32 27 26 40 25 18
Level 2 compulsory audit 205 55 161 471 74 159
IVDs
Applications completed without audit 148b     77    
IVD non-compulsory audit 17 41 65 10 35 46
IVD compulsory audit 159 26 45 82 29 39
Median Processing Time
Medical devices
Applications completed without audit 2,112b     2,105    
Non-compulsory auditc 497 21 21 310 27 24
Level 1 compulsory audit 32 23 9 40 23 13
Level 2 compulsory audit 205 49 158 471 60 155
IVDs
Applications completed without audit 148b     77    
IVD non-compulsory audit 17 33 58 10 22 36
IVD compulsory audit 159 21 41 82 18 29
  1. TGA time starts when the application is selected for audit, and does not include public holidays and weekends, and the time when we wait for information or payment from the sponsor.
  2. Auto-included applications for Class I and Class 1 IVD are complete within 24 hours, and not included in the figures above.
  3. Non-compulsory audit – estimate for the audit processing time does not include applications for reclassification of joint replacement medical devices received during transitional period (Class III Joint Reclassification medical devices), and applications supported by European Community (EC) certificates issued by certain notified bodies.

6.3. Post-market monitoring

6.3.1 Compliance reviews

As Class I medical devices are automatically included on the ARTG, we undertake post-market compliance reviews for these devices. This includes restricted word reviews, where applications for Class I devices are identified by the use of specific words indicative of risk, or listing issues relating to the inclusion of the device.

We also conduct targeted compliance reviews that are initiated on a case by case basis. These may be conducted in relation to devices of any Class.

Table 33 Restricted word Class 1 medical device and targeted compliance reviews
  2015-16 2016-17
July to June
Restricted word reviews
Reviews completed 0 54
Reviews commenced 1 55
Reviews on hand 1 1
Targeted compliance reviewsa
Reviews completed 104 35
Reviews commenced 83 45
Reviews on hand 164 175

6.3.2 Post-market reviews

We also undertake a range of post market reviews.

Table 34 Medical device targeted reviews
  2015-16 2016-17
July to June
Post market reviews
Reviews commenced - number of ARTG entries 80 396
Reviews completed - number of ARTG entries 83 239
Reviews on hand - number of ARTG entries 163 263

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 35 Number of medical device incident reports and processing times
  2015-16 2016-17
July to June
Device incident reports
Reports received 3,841 4,896
Reports completed 3,608 4,918
Reports still in progress 207 380
Processing time
Mean TGA processing time (days) 1 1
Median TGA processing time (days) 14 10
Percentage processed within target timeframe 100% 95%
Table 36 Medical device incident report outcomesa
  2015-16 2016-17
July to June
Incident report outcome
Reviewed and used for trend analysis purposes 2,988 4,125
Reviewed, no further action required 330 279
Product recall 40 70
Recall for product correction 19 4
Hazard alert 25 22
Product notification 1 0
Safety alert 9 20
Product enhancement/improvement notice 0 1
Instructions for use amended 3 5
Referral for post-market review 23 82
Refer to another TGA Branch 51 39
Company warned 0 13
Product suspended from ARTG 0 0
Product cancelled from ARTG 4 1
Manufacturing process improvements 10 12
Quality system process improvements 1 0
Maintenance carried out by the hospital 0 0
Change to design 13 3
Not device related 9 16
Other 39 81
  1. Outcomes are not mutually exclusive.

6.3.4 Devices manufacturing

Table 37 Outcomes of Quality Management System (QMS) audits of Australian manufacturers
  2015-16 2016-17
July to June
QMS audits (Australia)
Number of audits conducted 38 38
Satisfactory compliance (of completed audits) 79% 71%
Marginal compliance (of completed audits) 21% 24%
Unacceptable (of completed audits) 0% 0%
Close-out in Progress 0% 5%
Processing time
Initial audits conducted within 3 months of applicationa 17% 57%
Re-audits conducted within 6 months of due date 41% 16%
  1. The improvement in processing times for initial audits was the outcome of process improvement resulting in more timely internal notification of required audits, and more up to date status of manufacturers due to the Medical Devices Single Audit Program (MDSAP).
Table 38 Outcomes of QMS audits of overseas manufacturers
  2015-16 2016-17
July to June
QMS audits (overseas)
Number of audits conducted 20 26
Satisfactory compliance (of completed audits) 75% 92%
Marginal compliance (of completed audits) 15% 0%
Unacceptable (of completed audits) 10% 0%
Close-out in Progress 0% 8%
Processing time
Initial certification audits conducted within 6 months of applicationa 50% 80%
Certification re-audits conducted within 6 months of due date 17% 9%
  1. The improvement in processing times for initial audits was the outcome of process improvement resulting in more timely internal notification of required audits, and more up to date status of manufacturers due to the MDSAP.

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