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Background
COVID-19 has caused a rapid rise in demand for the manufacturing, importation and sale of face masks and respirators, and there has been an associated increase in medical device inclusions in the Australian Register of Therapeutic Goods (ARTG). There has also been a growth in concerns regarding the quality and performance of these kinds of devices.
The TGA Laboratories has developed capabilities to test surgical masks and respirators, to assess compliance with the requirements of key performance criteria. This testing, in conjunction with the Post-market Review of face masks, will provide the Australian community with information about the suitability of available face masks and respirators.
More information about different types of face masks and respirators has been published on the TGA website:
- Regulation of Personal Protective Equipment and COVID-19
- Guidance on Medical/Surgical Face Masks and Respirator Standards - Key Performance Aspects
Testing
You can view the test results at Face mask and respirator test reports.
The TGA Laboratories is conducting an assessment of the compliance of face masks and respirators included on the ARTG[1] as well as those supplied to the National Medical Stockpile under the Therapeutic Goods (Medical Devices—Face Masks and Other Articles) (COVID-19 Emergency) Exemption 2020. The masks and respirators in the National Medical Stockpile will be prioritised within our testing plan.
The TGA Laboratories, guided by the relevant Standards, is examining the following attributes of face masks and respirators:
- Visual Inspection - a visual and physical examination of labelling, design and construction quality
Fluid Resistance[2] - testing of the ability to provide a barrier against penetration by blood and/or other body fluids
NOTE: For face-masks and surgical respirators with major areas where the material or thickness varies, each of these areas is tested for fluid resistance e.g. we target seams, logos and lines if present in the main body of the mask.
- Particle Filtration - testing of the ability to filter out small, aerosolised particles
- Sterility - where a face product claims to be provided in a sterile state, this will be tested.
TGA testing is targeted at assessing a few key performance parameters for masks and respirators. This does not replace the manufacturer's obligation to have their products appropriately tested to demonstrate compliance with the essential principles for medical devices and any claimed standards on their labelling or application for ARTG inclusion.
The results of TGA laboratory testing will be made available and updated regularly on the Face mask and respirator test reports page. Please note that the information posted on the results page is correct at the time of publication, though should be considered as preliminary results, which may be altered as more information becomes available.
Where only labelling deficiencies are identified, the TGA is working with sponsors to resolve the issues without unnecessarily removing products from the market, where practical.
TGA laboratory testing can only verify the performance of devices in relation to the tests we have applied. There may be products that are found to be compliant based on TGA laboratory testing, that do not comply with other regulatory requirements.
In the event a product is found non-compliant or testing results are in dispute (other than labelling deficiencies) the Sponsor is instructed to quarantine the affected products. Whilst the product is quarantined, the TGA together with the Sponsor and Manufacturer; undertake further investigation of the matter to determine what actions are appropriate.
The testing results should be considered along with information published by the TGA about:
- Post-market review of face masks: Cancelled ARTG entries
- Post-market review of face masks - Non compliance notices
- Post-market review of face masks: ARTG entries subject to market actions
Result definitions
| Result | Definition |
|---|---|
| Compliant | This result indicates the batch was found compliant by TGA testing. |
| Non-compliant | This result indicates the batch was found non-compliant by TGA testing, and the Sponsor did not request review of the TGA result. |
Non-compliant - the Sponsor requested review of the TGA’s non-compliant result with evidence of compliance. Testing by a third-party laboratory could not proceed as there were insufficient samples, the Batch had expired or there was a lack of homogeneity.
| This result indicates the batch was found non-compliant by TGA testing, but the Sponsor had requested review by providing relevant evidence demonstrating the affected batch complied with requirements. However, this disparity between results could not be resolved through testing by a third-party laboratory because there were insufficient samples available from the same batch, the batch had expired or there was a lack of homogeneity in the sample. Consequently, the TGA’s non-compliant result remains the test outcome. |
| Non-compliant - the Sponsor requested review of the TGA’s non-compliant result with evidence of compliance. Testing from a third-party laboratory upheld the TGA’s finding of non-compliance. Consequently, the test outcome remains as ‘non-compliant’. | This result indicates that the batch was found non-compliant by TGA testing, and this result was confirmed by testing from a third-party laboratory. |
| Compliant - the Sponsor requested review of the TGA’s non-compliant result with evidence of compliance. Testing from a third-party laboratory supported the Sponsor’s evidence of compliance. Consequently, the TGA’s non-compliant result was overturned. | This result indicates that the batch was found non-compliant by TGA testing, but the result was overturned following testing from a third-party laboratory. |
| Non-compliant - the TGA’s examination of the goods, label and packaging identified non-compliance with applicable requirements. | This result indicates that visual inspection of the batch identified non-compliance with applicable labelling and/or packaging requirements. This non-compliance will be managed separately to the other test outcomes. |
Footnotes
| [1] | Not all products listed and/or tested on the ARTG have been supplied in Australia. |
|---|---|
| [2] | Not all face-mask standards have a requirement for fluid resistance. The TGA considers fluid resistance important for face-masks used in healthcare settings. The TGA is testing all face-masks and surgical respirators (not standard respirators) included on the ARTG for fluid resistance. There are 3 levels of fluid resistance specified in recognised face-mask standards. The TGA is testing face-masks at the highest level of fluid resistance claimed. Face-masks with no specific fluid resistance claims are tested at the lowest level. Face-mask with no fluid resistance may still be appropriate for use by the general public in non-healthcare settings to reduce the risk of the spread of infections, particularly in epidemic or pandemic situations. |
For more information about face masks visit Face masks and COVID-19.