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Medical device application processing times

19 February 2020

Australia's regulatory framework for therapeutic goods is undergoing a number of changes in response to the Review of Medicines and Medical Devices Regulation (MMDR).

MMDR Recommendation 21

The Government accepted MMDR recommendation 21 to 'establish target timeframes that reflect international benchmarks and the typical lifecycle of a medical device' for assessment and inclusion in the ARTG.

An independent reviewer was engaged to undertake consultation and examine how the TGA's process and timeframes compare with international regulators.

The review report outlines the timeframes for the regulatory frameworks in Australia, the USA, Canada, Japan, Brazil and the European Union (using the UK and the Netherlands as examples). Overall, it was found that the variation between regulatory systems make comparison difficult, and Table 1 in the report provides a summary comparison across jurisdictions.

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As outlined in the report, conformity assessment (or equivalent) timeframes vary between jurisdictions, and in many jurisdictions they also vary in line with the risk of the medical device being assessed. No other jurisdiction examined splits the conformity assessment (or equivalent) and market authorisation steps (i.e., inclusion in the ARTG), as we do in Australia. This split in Australia relates to the extensive use of approvals from comparable overseas regulators, with other jurisdictions using much less or no overseas approvals.

Statutory timeframes

Medical device applications are already subject to two statutory timeframes under the Therapeutic Good Act 1989 (the Act) and further information can be found in the Medical Devices section of the TGA's Annual performance statistics report. After considering the report findings, no changes are proposed to these statutory timeframes.

Circumstances that affect processing times

All applications are assessed individually, and actual processing times can vary due to circumstances including:

  • whether the application lodged is complete and includes all necessary supporting information.
  • how quickly a sponsor responds to any requests for additional information.
  • Whether the clinical information provided aligns with the requirements of the Australian Clinical evidence guidelines documents for medical devices.

The Australian Regulatory Guidelines for Medical Devices contains information on the inclusion process for medical devices and IVD and the conformity assessment processes for medical devices and IVDs.

The TGA has also developed a hints and tips webpage to assist sponsors with ensuring their applications are processed expeditiously. Sponsors should note the requirements for each type of application and have all documentation to hand when an application is submitted. This will help reduce the need for the TGA to request further information from Sponsors and will help expedite the assessment process. Sponsors are also encouraged to respond to requests for information as promptly as possible after they receive them as this will also help the application progress as quickly as possible.

Medical device application processing times, by financial year

2018-2019 FY

The TGA processing times for conformity assessment applications and applications for inclusion on the ARTG are calculated using the TGA Annual Performance Statistics Report July 2018 to June 2019. Two processing times are displayed in TGA working days, indicating how long it takes to finalise 75 and 90 per cent of applications submitted.

Table 1: Conformity assessment applications
Conformity assessment 75% of applications processed in... 90% of applications processed in...
New applications
Medical devices 220 TGA working days 238 TGA working days
IVDs 200 TGA working days 227 TGA working days
Variations (including re-certifications)
Medical devices 194 TGA working days 225 TGA working days
IVDs 126 TGA working days 200 TGA working days

Based on 235 CA applications finalised 010/7/18 to 30/06/19:

  • New: 68 (43 medical devices, 25 IVDs)
  • Variation: 167 (139 medical devices, 28 IVDs)
Table 2: Applications for Inclusion in ARTG selected for audit
Inclusion in the ARTG % Selected for audit
Medical devices
Class I 0% (automatically included on ARTG overnight)
Class I (sterile) 3%
Class I (measuring) 4%
Class IIa 4%
Class IIb 23%
Class III 82%
AIMD 100%
IVDs
Class 1 5%
Class 2 37%
Class 3 71%
Class 4 0% (TGA conformity assessment is required)
  • Note - All applications that are not selected for audit are included on the ARTG within 20 days.
Table 3: Processing times - applications for Inclusion in ARTG
Inclusion in the ARTG – Selected for audit 75% of audited applications processed in... 90% of audited applications processed in...
Medical devices
Class I NA (included overnight) NA (included overnight)
Class I (sterile) 39 TGA working days 42 TGA working days
Class I (measuring) 23 TGA working days 97 TGA working days
Class IIa 84 TGA working days 188 TGA working days
Class IIb 126 TGA working days 167 TGA working days
Class III 68 TGA working days 118 TGA working days
AIMD 117 TGA working days 120 TGA working days
IVDs
Class 1 137 TGA working days 184 TGA working days
Class 2 120 TGA working days 137 TGA working days
Class 3 87 TGA working days 117 TGA working days
Class 4 NA - TGA conformity assessment is required NA -TGA conformity assessment is required
  • Includes approved, rejected and withdrawn applications. Excludes variation applications. Audited applications calculated on TGA working days from receipt of payment for application and does not include days 'with the sponsor' i.e., waiting for input from sponsor. Sponsors are generally provided with 20 working days to provide information requested by TGA. Sponsors may choose/be able to provide this sooner. Extensions may be granted at the request of the sponsor. Multiple requests for information may be made during the audit process.
  • Data based on 2749 inclusion applications assessed and finalised 1/7/18 to 30/6/19:
    • Medical devices: 2375 (195 Class I(s), 46 Class I(m), 1186 Class IIa, 590 Class IIb, 331 Class III, 27 AIMD)
    • IVDs: 217 (77 Class 1, 70 Class 2, 41 Class 3, 29 Class 4)
  • These application numbers do not include Class I medical device applications (automatically included overnight).
  • Note - most Class 1 IVDs are autoincluded. However, a small subset of Class 1 IVDs (e.g., IVDs for self-testing and IVDs for point-of-care) are selected for mandatory application audit.