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Annual performance statistics report: July 2018 to June 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
2017-18 | 2018-19 | |
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July to June | ||
Conformity assessment applications | ||
Applications received | 309 | 279 |
Applications on hand | 251 | 252 |
Applications completed | 273 | 273 |
7.1.2 Outcomes
2017-18 | 2018-19 | |
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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
[a] | The table has been broken down into 'New' and 'Variation' assessment application to provide additional transparency. In reviewing the changes in the reporting, the final total was increased by one. |
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7.1.3 Processing timeframes
We are required to complete conformity assessment applications within 255 working days.
2017-18 | 2018-19 | |
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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
2017-18 | 2018-19 | |
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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
[a] | 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 data migration processes. |
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[b] | 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 data migration processes. |
[c] | The number of applications for Class 1 IVD includes auto-included devices and applications completed with or without audit. |
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.
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').
2017-18 | 2018-19 | |||||
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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
[a] | TGA time starts when the application is selected for audit, is based on working days, and excludes the time when we wait for information or payment from the sponsor. |
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[b] | Days taken for sponsor to provide further information/pay fees etc. |
[c] | 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). |
[c] | Due to technical and data migration issues the timeframes calculated for this reporting period may have some minor inaccuracies. |
2017-18 | 2018-19 | |
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July - June | ||
Application type (proposed) | ||
A: Conformity Assessment (priority applicant) determinations | 0 | 1 |
B: Medical Devices (priority applicant) determinations | 0 | 0 |
Footnotes
[a] | Priority designation is a formal decision by the TGA to assign priority to the assessment of an application to include a medical device in the ARTG. Granting of priority designation does not guarantee approval for the application itself. Designation decisions lapse after six (6) months, unless an application for either TGA conformity assessment or ARTG inclusion is received during this time. |
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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.
2017-18[b] | 2018-19 | |
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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
[a] | The number of targeted reviews includes the number of compliance reviews undertaken in relation to all classes of medical devices. |
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[b] | Due to technical and data migration issues the numbers calculated for this reporting period may have some minor inaccuracies. |
7.3.2 Post-market reviews
2017-18 | 2018-19 | |
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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.
2017-18 | 2018-19 | |
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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% |
2017-18 | 2018-19 | |
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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
[a] | Outcomes are not mutually exclusive. |
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[b] | The Incident report (DIR) may be referred onto another section for their action. These areas include but are not limited to Recalls, Regulatory Compliance, Clinical Trials and Advertising. Generally these reports are closed off in the DVM database unless there is more than one issue noted within the report. It may also still be investigated by DVM depending on this issue. |
7.3.4 Devices manufacturing
2017-18 | 2018-19 | |
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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% |
2017-18 | 2018-19 | |
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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% |
2017-18 | 2018-19 | |
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July to June | ||
MDSAP Assessments (overseas) | ||
Number of auditing organisation assessments | 8 | 3 |
Number of witnessed manufacturing audits | 5 | 5 |