You are here
Medical device application processing times
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.
- Report on TGA processes and timeframes for the regulation of medical devices and access to market: International benchmarking (pdf,443kb)
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.
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
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.
|Conformity assessment||75% of applications processed in...||90% of applications processed in...|
|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:
|Inclusion in the ARTG||% Selected for audit|
|Class I||0% (automatically included on ARTG overnight)|
|Class I (sterile)||3%|
|Class I (measuring)||4%|
|Class 4||0% (TGA conformity assessment is required)|
|Inclusion in the ARTG – Selected for audit||75% of audited applications processed in...||90% of audited applications processed in...|
|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|
|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|