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Annual performance statistics report: July 2018 to June 2019

21 October 2019

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7. Medical devices

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

  • Conformity assessment: This 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 (or for particular products, 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.
  • 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.
  • Priority review of medical devices: A new pathway has been developed to allow faster processing of applications for devices that meet certain criteria for novelty and health benefits.
  • Medical device manufacturing: The TGA assesses the quality management systems of medical device manufacturers seeking TGA conformity assessment certification. This may be through onsite inspections or desktop assessment of third party inspection reports, or a combination of these methods. Surveillance inspections are also undertaken to assess continuing compliance. In addition, the TGA is a Regulatory Authority of the Medical Devices Single Audit Program (MDSAP) that assesses and recognises third party Auditing Organisations for the purposes of certifying medical device manufacturers.

7.1. Conformity assessment

7.1.1 Applications

Table 32 Number of conformity assessment applications (medical devices including IVDs)
2017-18 2018-19
July to June
Conformity assessment applications
Applications received 309 279
Applications on hand 251 252
Applications completed 273 273

7.1.2 Outcomes

Table 33[a] Outcomes of conformity assessment applications
2017-18 2018-19
July to June
New
Approved 58 63
Rejected 1 0
Withdrawn/ Lapsed 35 17
Variation (changes and re-certifications)
Approved 166 169
Rejected 1 0
Withdrawn/ Lapsed 12 24

Footnotes


7.1.3 Processing timeframes

We are required to complete conformity assessment applications within 255 working days.

Table 34 TGA processing times for new devices and variations
2017-18 2018-19
July to June
New devices
Mean TGA processing time (days) 131 160
Median TGA processing time (days) 189 196
Variations (changes and recertifications)
Mean TGA processing time (days) 110 114
Median TGA processing time (days) 95 97

7.2. Inclusion of medical devices (including IVDs)

7.2.1 Applications

Table 35 Applications for inclusion - medical devices (including IVDs)
2017-18 2018-19
July to June
Class I medical devices[a]
Applications received 4805 1545
Applications completed 4804 1631
Class I measuring medical devices
Applications received 62 46
Applications completed 64 46
Applications on hand[b] 5 0
Class I sterile medical devices
Applications received 255 198
Applications completed 240 207
Applications on hand[b] 7 1
Class IIa medical devices
Applications received 1219 1186
Applications completed 1191 1191
Applications on hand[b] 92 27
Class IIb medical devices
Applications received 650 581
Applications completed 568 589
Applications on hand[b] 132 50
Class III medical devices
Applications received 406 476
Applications completed 378 404
Applications on hand[b] 208 194
Class III Joint Reclassification medical devices
Applications received 0 0
Applications completed 88 6
Applications on hand[b] 5 0
Active Implantable Medical Devices (AIMD)
Applications received 24 37
Applications completed 34 28
Applications on hand[b] 10 18
Class 1 IVDs[c]
Applications received 74 72
Applications completed 76 72
Applications on hand[b] 2 1
Class 2 IVDs
Applications received 81 67
Applications completed 80 71
Applications on hand[b] 13 7
Class 3 IVDs
Applications received 58 53
Applications completed 60 43
Applications on hand[b] 14 20
Class 4 IVDs
Applications received 27 30
Applications completed 27 30
Applications on hand[b] 1 0

Footnotes


7.2.2 Outcomes

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

Table 36 Outcomes of medical device applications by classification
2017-18 2018-19
July to June
Number (% of Total)
Device Classification Approved/ Accepted Rejected/ Lapsed Withdrawn Total of applications by classification Approved/ Accepted Rejected/ Lapsed Withdrawn Total of applications by classification
Class I 4,804
(65%)
0 0 4,804
(63%)
1691
(40%)
0 0 1691
(39%)
Class I Measurement 60
(1%)
0 4
(2%)
64
(1%)
45
(1%)
0 1
(0.6%)
46
(1%)
Class I Sterile 222
(3%)
0 18
(9%)
240
(3%)
193
(5%)
0 14
(9%)
207
(5%)
Class IIa 1,138
(16%)
7
(15%)
46
(24%)
1.191
(16%)
1148
(27%)
3
(17%)
42
(26%)
1191
(27%)
Class IIb 513
(7%)
9
(19%)
46
(24%)
568
(8%)
535
(13%)
3
(17%)
51
(31%)
589
(14%)
Class III 306
(4%)
17
(35%)
55
(28%)
378
(5%)
362
(9%)
6
(35%)
36
(22%)
404
(9%)
Class III Reclassification 59
(1%)
15
(31%)
14
(7%)
88
(1%)
5
(0.1%)
0 1
(0.6%)
6
(0.1%)
AIMD 33
(0.5%)
0 1
(0.5%)
34
(0.5%)
28
(1%)
0 0 28
(0.6%)
Class 1 IVD 73
(1%)
0 3
(2%)
76
(1%)
71
(2%)
1
(56%)
0 72
(2%)
Class 2 IVD 75
(1%)
0 5
(3%)
80
(1%)
60
(1%)
1
(6%)
10
(6%)
71
(2%)
Class 3 IVD 58
(0.7%)
0 2
(1%)
60
(1%)
32
(1%)
3
(18%)
8
(5%)
43
(1%)
Class 4 IVD 27
(0.3%)
0 0 27
(0.4%)
30
(1%)
0 0 30
(0.7%)
Total of all applications by status 7,368
(97%)
48
(0.6%)
194
(3%)
7,610
(100%)
4185
(96%)
17
(0.4%)
163
(4%)
4378
(100%)

7.2.3 Processing times

A Level 1 audit may include clarification of the device classification, a conformity assessment procedure, and/or a review of packaging and labelling to ensure it meets requirements. A Level 2 audit requires the information for a Level 1 audit plus one or more of the following: clinical evidence, risk management report(s), efficacy and performance data, and/or audit reports from Notified Bodies. The target timeframe 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').

Table 37 Processing times for medical device application audits (including IVDs)
2017-18 2018-19
Number of applications (% of Total) Sponsor days TGA days[a] Number of applications (% of Total) Sponsor days[b][d] TGA days[a][d]
Mean Processing Time
Medical devices
Applications completed without audit 2,021 (79%) 1850 (76%)
Non-compulsory audit[c] 197 (8%) 58 58 201 (8%) 44 99
Level 1 compulsory audit 27 (1%) 23 33 156 (6%) 37 24
Level 2 compulsory audit 318 (12%) 79 83 236 (10%) 63 99
Total 2,563 (100%) 2443 (100%)
IVDs
Applications completed without audit 115 (65%) 86 (59%)
IVD non-compulsory audit 5 (3%) 34 57 8 (5%) 18 36
IVD compulsory audit 56 (32%) 29 81 53 (36%) 82 94
Total 176 (100%) 147 (100%)
Median Processing Time
Medical devices
Applications completed without audit 2,021 (79%) 1850 (76%)
Non-compulsory audit[c] 197 (8%) 33 24 201 (8%) 29 56
Level 1 compulsory audit 27 (1%) 22 23 156 (6%) 31 15
Level 2 compulsory audit 318 (12%) 54 47 236 (10%) 50 85
Total 2,563 (100%) 2443 (100%)
IVDs
Applications completed without audit 115 (65%) 86 (59%)
IVD non-compulsory audit 5 (3%) 21 23 8 (5%) 19 25
IVD compulsory audit 56 (32%) 24 64 53 (36%) 66 84
Total 176 (100%) 147 (100%)

Footnotes


Table 38 Number of priority review determinations[a] granted
2017-18 2018-19
July - June
Application type (proposed)
A: Conformity Assessment (priority applicant) determinations 0 1
B: Medical Devices (priority applicant) determinations 0 0

Footnotes


7.3. Post-market monitoring

7.3.1 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 potentially inappropriate Class I device inclusions 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 39 Restricted word Class 1 medical device and targeted compliance reviews
2017-18[b] 2018-19
July to June
Restricted word reviews
Reviews completed 122 40
Reviews commenced 122 40
Reviews on hand 9 0
Targeted compliance reviews[a]
Reviews completed 166 235
Reviews commenced 211 250
Reviews on hand 229 15

Footnotes


7.3.2 Post-market reviews

Table 40 Medical device targeted reviews
2017-18 2018-19
July to June
Post market reviews
Reviews commenced - number of ARTG entries 620 545
Reviews completed - number of ARTG entries 568 285
Reviews on hand - number of ARTG entries 315 677

7.3.3 Medical device incident reports

A medical device incident is an event associated with the use or misuse of a medical device that resulted in, or could have resulted in (near-incident): serious injury, illness or death to patient, healthcare worker or other person. Australian sponsors of medical devices must actively monitor their devices' post market performance and report incidents to the TGA. Reporting of incidents, or near-incidents, by users is voluntary.

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

Table 41 Number of medical device incident reports and processing times
2017-18 2018-19
July to June
Device incident reports
Reports received 5348 5874
Reports completed 4653 5654
Reports still in progress 283 239
Processing time
Mean TGA processing time (days) 1 14
Median TGA processing time (days) 6 9
Percentage processed within target timeframe 98% 94%
Table 42 Medical device incident report outcomes[a]
2017-18 2018-19
July to June
Incident report outcome
Reviewed and used for trend analysis purposes 4713 5129
Reviewed, no further action required 252 280
Product recall 27 55
Recall for product correction 57 72
Hazard alert 41 68
Product notification 0 0
Safety alert 2 22
Product enhancement/improvement notice 0 8
Instructions for use amended 6 8
Referral for post-market review 139 94
Refer to another TGA Branch[b] 51 24
Company warned 9 3
Product suspended from ARTG 0 4
Product cancelled from ARTG 2 16
Manufacturing process improvements 10 71
Quality system process improvements 2 3
Maintenance carried out by the hospital 0 1
Change to design 4 15
Not device related 3 2
Other 403 47

Footnotes


7.3.4 Devices manufacturing

Table 43 Outcomes of Quality Management System (QMS) audits of Australian manufacturers
2017-18 2018-19
July to June
QMS audits (Australia)
Number of audits conducted 41 35
Satisfactory compliance (of completed audits) 92% 93%
Marginal compliance (of completed audits) 8% 7%
Unacceptable (of completed audits) 0% 0%
Close-out in Progress 37% 23%
Processing time
Initial audits conducted within 3 months of application 83% 25%
Re-audits conducted within 6 months of due date 46% 57%
Table 44 Outcomes of QMS audits of overseas manufacturers
2017-18 2018-19
July to June
QMS audits (overseas)
Number of audits conducted 30 34
Satisfactory compliance (of completed audits) 100% 100%
Marginal compliance (of completed audits) 0% 0%
Unacceptable (of completed audits) 0% 0%
Close-out in Progress 60% 38%
Processing time
Initial certification audits conducted within 6 months of application 72% 48%
Certification re-audits conducted within 6 months of due date 42% 15%
Table 45 Outcomes of MDSAP
2017-18 2018-19
July to June
MDSAP Assessments (overseas)
Number of auditing organisation assessments 8 3
Number of witnessed manufacturing audits 5 5

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