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Post-market review of face masks - Non compliance notices

29 September 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.

ARTG Sponsor Manufacturer Device/Product name Scope of 9D variation

Details of consent to supply non-compliant device

335335

M House Pty Ltd

Baoji Taidakang Medical Technology Co Ltd

Public respirator, single-use

Variation of GMDN code and intended purpose to remove the 'N95' reference

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.

332465

CK Surgitech Pty Ltd

V&Q Manufacturing Corporation

Mask, surgical, single use

Variation of GMDN code from 'surgical/medical respirator, single use' to 'Mask, surgical, single use'

334243

Kogan Australia Pty Ltd

Hubei Qianjiang Kingphar Medical Material Co Ltd

Mask, surgical, single use

Variation of GMDN code from 'surgical/medical respirator, single use' to 'Mask, surgical, single use'

334244

Kogan Australia Pty Ltd

Sunsmed Protective Products Ltd

Mask, surgical, single use

Variation of GMDN code from 'surgical/medical respirator, single use' to 'Mask, surgical, single use'

337634

Smyth Surgical Pty Ltd

San Huei United Company Ltd

Public respirator, single-use

Variation of GMDN code from 'Airway protection facemask' to 'Public respirator, single use' and intended purpose change to remove 'N99' and 'FFP2' references.

341022

GMP Consulting Pty Ltd

Shenzhen Moph Biotech Co Ltd

Public respirator, single-use

Variation of intended purpose to remove KN95 reference