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Half yearly performance report - January to June 2015
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
|Applications on hand||162||115||123|
Figure 4: Outcomes of conformity assessment applications
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- Withdrawn/Lapsed - over 160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- Withdrawn/Lapsed - under 120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- Withdrawn/Lapsed - over 80
- Jan-Jun 2014
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.
|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)
|Class 1 medical devicesa|
|Class 1 measuring medical devices|
|Applications on handb||7||3||4|
|Class 1 sterile medical devices|
|Applications on handb||42||7||7|
|Class IIa medical devices|
|Applications on handb||226||58||85|
|Class IIb medical devices|
|Applications on handb||130||52||61|
|Class III medical devices|
|Applications on handb||355||218||260|
|Class III Joint Reclassification medical devicesc|
|Applications on handb||891||252||538|
|Active Implantable Medical Devices (AIMD)|
|Applications on handb||50||23||51|
|Class 1 IVDs|
|Applications on handb||8||3||7|
|Class 2 IVDs|
|Applications on handb||28||5||30|
|Class 3 IVDs|
|Applications on handb||34||15||22|
|Class 4 IVDs|
|Applications on handb||1||0||0|
- 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.
- Applications on hand - figures shown are correct as of the date when the data was extracted
- 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.
Class I automatically included medical devices are not counted in the outcomes for inclusion applications as these applications cannot be rejected.
|Number of applications|
|Class 1 Measurement||36||2||6|
|Class 1 Sterile||124||2||4|
|Class III Reclassification||119||1||13|
|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').
|Number of applications||Mean Audit Processing Time|
|Sponsor days||TGA daysb|
|Applications completed without audit||1136a|
|Level 1 compulsory audit||11||17||5|
|Level 2 compulsory audit||155||42||82|
|Applications completed without audit||204a|
|IVD non-compulsory audit||4||36||11|
|IVD compulsory audit||71||22||14|
- These figures do not include applications for Class I and Class 1 IVD auto-included devices. These applications are complete within 24 hours.
- 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.
- 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).
|Restricted word reviews|
|Reviews on hand||13||0||0|
|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.
|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.
|Reports still in progress||498||169||155|
|Mean TGA processing time||59||19||14|
|Percentage processed within target timeframe||82%||86%||85%|
|Reviewed and used for trend analysis purposes||862||1801||1248|
|Reviewed, no further action required||583||689||392|
|Recall for product correction||18||5||13|
|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|
|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|
- Outcomes are not mutually exclusive
- Exemptions include custom made medical devices, importation of samples, etc.