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Post-market review of face masks - Non compliance notices
To keep everyone informed about our post-market review of face masks, we are publishing information about masks that require amendments to comply with Australian regulatory labelling requirements, or require their ARTG entry to be amended.
Examples of non-compliances include:
- Australian sponsor information and address are missing in the labelling;
- Manufacturer's details are incomplete or absent;
- Some product identifying information, including information about the product is not available or provided in a language other than English;
- Information relating to the product claims or compliance to standards is incomplete, inaccurate, or provided in a language other than English;
- Incorrect Global Medical Device Nomenclature (GMDN) code was chosen; or
- Intended purpose of the device was found to contain incorrect or misleading information.
Further information on interpreting face mask labelling claims is available on the TGA website.
Given the demand for face masks during the COVID-19 pandemic, the TGA may consent to the import, supply, or export of face masks that do not currently meet the labelling requirements of Essential Principle 13 for a limited period of time.
Where non-compliance is identified, sponsors can submit an application to the TGA seeking our consent to import, supply or export a medical device that does not comply with the Essential Principles. Each application is assessed with consideration to the relative risk related to the non-compliance, and the mitigations that the manufacturer or sponsor has put in place. Sponsors have continued responsibility to demonstrate the safety and performance of any medical device supplied.
Where inaccuracies have been noted with information the sponsor has provided for an ARTG entry, the TGA will work with the sponsor to rectify the issue. Further information, and the request form, for variation of ARTG entries under section 9D of the Therapeutic Goods Act 1989.
When the TGA has processed and accepted these applications, details will be provided below.
Non compliance notices
Displaying 1 - 19 of 19
ARTG number: 332465
Sponsor: CK Surgitech Pty Ltd
Manufacturer: V&Q Manufacturing Corporation
Device/Product name: Mask, surgical, single use
Scope of 9D variation: Variation of GMDN code from 'surgical/medical respirator, single use' to 'Mask, surgical, single use'
ARTG number: 332802
Sponsor: Allen Mason International Pty Ltd
Manufacturer: Guangdong Owgels Science & Technology Co Ltd
Device/Product name: Mask, surgical, single use
Scope of 9D variation: Variation of GMDN code from 'Mask' to 'Mask, surgical, single use' and intended purpose to reflect a surgical mask
ARTG number: 333562
Sponsor: AGMK Consulting Pty Ltd
Manufacturer: Shanghai Hua En Industrial Co Ltd
Device/Product name: Mask, surgical, single use
Scope of 9D variation: Variation of GMDN code from 'airway protection face mask' to surgical mask
ARTG number: 333831
Sponsor: Aus Medical Orthoses
Manufacturer: Makrite Industries Inc.
Device/Product name: Surgical/medical respirator, single use
Scope of 9D variation: Variation of GMDN code and intended purpose to a filtering mask
ARTG number: 334243
Sponsor: Kogan Australia Pty Ltd
Manufacturer: Hubei Qianjiang Kingphar Medical Material Co Ltd
Device/Product name: Mask, surgical, single use
Scope of 9D variation: Variation of GMDN code from 'surgical/medical respirator, single use' to 'Mask, surgical, single use'
ARTG number: 334244
Sponsor: Kogan Australia Pty Ltd
Manufacturer: Sunsmed Protective Products Ltd
Device/Product name: Mask, surgical, single use
Scope of 9D variation: Variation of GMDN code from 'surgical/medical respirator, single use' to 'Mask, surgical, single use'
ARTG number: 335335
Sponsor: M House Pty Ltd
Manufacturer: Baoji Taidakang Medical Technology Co Ltd
Device/Product name: Public respirator, single-use
Scope of 9D variation: Variation of GMDN code and intended purpose to remove the 'N95' reference
Details of consent to supply non-compliant device:
Update 29 September 2020: The sponsor has provided new information to the TGA that demonstrates compliance with all regulatory requirements including the use of the 'N95' label to the device. Any supply of the stock of these devices has therefore been lawful.
ARTG number: 335494
Sponsor: Meditech Medical Supplies.Com
Manufacturer: Bazhou Jinsheng Medical Instrument Co Ltd
Device/Product name: Shield, face
Scope of 9D variation: Variation of GMDN code from 'Mask, surgical, single use' to reflect a face shield
ARTG number: 335620
Sponsor: 3M Australia Pty Ltd
Manufacturer: 3M United Kingdom Plc
Device/Product name: Public respirator, single-use
Scope of 9D variation: Intended purpose change to remove N95 claim
ARTG number: 335785
Sponsor: Artec Chemical Australia Pty Ltd
Manufacturer: Artec Chemical Co Ltd
Device/Product name: Mask, surgical, single use
Scope of 9D variation: Variation of GMDN code from 'Mask' to 'Mask, surgical, single use' and intended purpose to reflect a surgical mask
ARTG number: 336378
Sponsor: Willieston International Pty Ltd
Manufacturer: Guangdong Hongze Ecological Treatment Engineering Co Ltd
Device/Product name: Mask, surgical, single use
Scope of 9D variation: Variation of GMDN code from 'Surgical/medical face mask, reprocessed' to 'Mask, surgical, single use'
ARTG number: 337634
Sponsor: Smyth Surgical Pty Ltd
Manufacturer: San Huei United Company Ltd
Device/Product name: Public respirator, single-use
Scope of 9D variation: Variation of GMDN code from 'Airway protection facemask' to 'Public respirator, single use' and intended purpose change to remove 'N99' and 'FFP2' references.
ARTG number: 340011
Sponsor: Inntex Integrated Pty Ltd
Manufacturer: Zhangzhou Kangwei Medical Equipment Co Ltd
Device/Product name: Public respirator, single use
Scope of 9D variation: Variation of GMDN code to 'Public respirator, single use' and intended purpose to 'face mask for general public'
ARTG number: 340497
Sponsor: Kogan Australia Pty Ltd
Manufacturer: Winner Medical Co Ltd
Device/Product name: Mask, surgical, single use
Scope of 9D variation: Variation of GMDN code from 'surgical respirator single use' to 'mask, surgical, single use'. Intended purposed changed to remove reference of surgical respirator.
ARTG number: 340517
Sponsor: Strapit Medical and Sports Supplies Pty Ltd
Manufacturer: Shanghai Zogear Industries Co Ltd
Device/Product name: Mask, surgical, single use
Scope of 9D variation: Variation of intended purpose to reference level 2 instead of level 1 barrier surgical mask
ARTG number: 341022
Sponsor: GMP Consulting Pty Ltd
Manufacturer: Shenzhen Moph Biotech Co Ltd
Device/Product name: Public respirator, single-use
Scope of 9D variation: Variation of intended purpose to remove KN95 reference
ARTG number: 341464
Sponsor: Vicki Partridge Pty Ltd
Manufacturer: Neolithic Tech Co Ltd
Device/Product name: Public respirator, single-use
Scope of 9D variation: Variation of intended purpose changed to remove superfluous claims.
ARTG number: 341618
Sponsor: PPS Emergency Supplies
Manufacturer: Fujian BBC Inc
Device/Product name: Public respirator, single use
Scope of 9D variation: Variation of GMDN code to 'Public respirator, single use'
ARTG number: 346032
Sponsor: Vitacore Industries Pty Ltd
Manufacturer: Vitacore Industries Pty Ltd
Device/Product name: Surgical/medical respirator, single-use
Scope of 9D variation: N/A