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Post-market review of face masks - Non compliance notices

6 November 2020

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.

Displaying 1 - 19 of 19

Enter an ARTG number, sponsor, manufacturer or product name

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