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Regulation of Personal Protective Equipment and COVID-19

13 August 2020

In response to COVID-19, there is increasing interest in understanding the regulation of Personal Protective Equipment (PPE) that might be used for therapeutic purposes including face masks, gowns and gloves. The following guidance is designed to provide:

  • An overview of how these products are regulated
  • Information for manufacturers of PPE to help meet regulatory obligations
  • Information about including a medical device on the Australian Register of Therapeutic Goods (ARTG)
  • Information for consumers of PPE, including healthcare professionals.

For additional information relating to the regulation of face masks during the COVID-19 pandemic, see Face masks and respirators that are regulated by the TGA.

Overview of the regulation of PPE

Under item 2A of Schedule 1 of the Therapeutic Goods (Excluded Goods) Determination 2018 the following products are declared to not be therapeutic goods:

articles that are non-sterile personal protective equipment or safety apparel other than articles specified in item 1 of Schedule 1 to the Therapeutic Goods (Medical Devices - Specified Articles) Instrument 2020

Item 1 of Schedule 1 to the Therapeutic Goods (Medical Devices - Specified Articles) Instrument 2020 specifies the following items to be medical devices:

articles that are non-sterile personal protective equipment or safety apparel (including but not limited to aprons, face masks, gloves, goggles, gowns and visors) intended, by the person under whose name the articles are or are to be supplied, to be used for the prevention of the transmission of disease between persons, including where that intention may be ascertained from the articles being represented as suitable for use in surgery, or clinical, medical or other health services

The combined effect of the above legislation is that non-sterile PPE (including aprons, face masks, gloves, goggles gowns and visors) that is presented to be, or claimed to be, for use for the prevention of the transmission of disease between people is a medical device. These products are therefore regulated by the TGA as medical devices under the Therapeutic Goods Act 1989. They will need to be included on the ARTG before they can be supplied.

Note

The TGA will infer the intended use for the PPE from the labelling on the packaging, instructions for use, advertising, and information in the manufacturer’s technical documentation. If any of these materials suggest that the goods are suitable for use in surgery, or clinical, medical or other health services, the TGA will conclude that the PPE is intended to be used for prevention of the transmission of disease between people.

However, even if these materials do not suggest use in surgery, clinical, medical or other health services, other aspects of the PPE’s presentation could still suggest that it is for the prevention of the transmission of disease.

PPE that meets the definition of a medical device will generally be regulated as either:

  • a Class I medical device;
  • a Class Is (sterile) medical device; or
  • a Class IIa medical device.

Non-sterile PPE or safety apparel (including but not limited to aprons, face masks, gloves, goggles, gowns and visors) that is not presented to be, or claimed to be, for use for the prevention of transmission of disease between people is not a therapeutic good. It therefore does not need to be included on the Australian Register of Therapeutic Goods (ARTG) before it can be supplied.

You can check the classification of your medical device using our online classification tool.

Manufacturing PPE

If you are manufacturing PPE that makes therapeutic claims or is intended for use in a clinical setting, your product will meet the definition of a medical device and will need to meet the regulatory requirements under:

All classes of medical devices need conformity assessment evidence before they can be manufactured and supplied. Conformity assessment is the systematic and ongoing examination of evidence and procedures to ensure that a medical device (including IVD medical devices) complies with the Essential Principles. These Principles relate to aspects of the device including its design and construction. Demonstrating compliance with them establishes that the product is safe and fit for its intended purpose.

Manufacturers of all medical devices (including IVD medical devices) manufactured and/or supplied in Australia should ensure that they have:

  • appropriate conformity assessment procedures in place for the device; and
  • appropriate documentation demonstrating compliance of the device with the Essential Principles.

Compliance with the Essential Principles can be demonstrated by showing that your product meets an applicable standard.

Note

Although the use of standards to demonstrate compliance with the Essential Principles is not mandated under the Regulations the TGA recognises certain standards to assist manufacturers in complying with the conformity assessment procedures and the Essential Principles.

Standards for PPE

The following information might be of assistance should you be considering supplying these types of devices in the COVID-19 pandemic.

When choosing which standards to apply to each device, manufacturers should take into consideration the:

  • intended purpose of the device
  • environment in which it is likely to be used
  • likely users of the device; and
  • generally acknowledged state-of-the-art.

Note

The TGA does not hold, and cannot supply you with, relevant copies of the standards listed below.

Information for manufacturers responding to COVID-19 is available on the Standards Australia website at Supporting the COVID-19 national response and Australian manufacturers (pdf,101kb).

Surgical masks and respirators

  • ISO 22609:2004 Clothing for protection against infectious agents - Medical face masks - Test method for resistance against penetration by synthetic blood (fixed volume, horizontally projected)
  • AS/NZS 4381:2015 'Single use face masks for use in health care'
  • ASTM F2100 - 19 Standard Specification for Performance of Materials Used in Medical Face Masks
  • U.S. National Institute of Occupational Safety and Health (NIOSH) 42 CFR 84 Respiratory Protective Devices
  • AS ISO 16900.3 2015 Respiratory protective devices - Methods of test and test equipment Determination of particle filter penetration
  • AS NZS 1716 2012 Respiratory protective devices
  • ISO 22609: 2004 Clothing for protection against infectious agents - Medical face masks - Test method for resistance against penetration by synthetic blood
  • EN 14683:2019 Medical face masks - Requirements and test methods
  • AS NZS 1715 2009 Selection, use and maintenance of respiratory protective equipment

Note

AS/NZS 1716:2012 'Respiratory protective devices', the standard for P2 respirators, and the NIOSH standard 42 CFR 84 for N95 masks can be used as functional standards for both medical devices and for respirators that are not medical devices.

Surgical gowns

  • ANSI/AAMI PB70:2003, 'Liquid barrier performance and classification of protective apparel and drapes intended for use in health care facilities.'
  • ASTM F2407 is an umbrella document, which describes testing for surgical gowns: tear resistance, seam strength, lint generation, evaporative resistance, and water vapor transmission.
  • I.S. EN 13795:2011 Surgical Drapes, Gowns and Clean air Suits, Used as Medical Devices for Patients, Clinical Staff and Equipment - General Requirements for Manufacturers, Processors and Products, Test Methods, Performance Requirements and Performance Levels
  • ASTM 1670 Test Method for Resistance of Materials Used in Protective Clothing to Penetration by Synthetic Blood
  • ASTM 1671 Resistance of Materials Used in Protective Clothing to Penetration by Blood-Borne Pathogens Using Phi-X174 Bacteriophage Penetration as a Test System
  • ISO 22610 Surgical drapes, gowns and clean air suits, used as medical devices for patients, clinical staff and equipment
  • ISO 22612 Clothing for protection against infectious agents - Test method for resistance to dry microbial penetration

Surgical gloves

  • ISO 10282:2014 Single-use sterile rubber surgical gloves-Specification
  • AS/NZS 4179:1997 (ISO 10282:1994) Australian/New Zealand Standard® Single-use sterile surgical rubber gloves-Specification
  • BS ISO 10282:2014 Single-Use Sterile Rubber Surgical Gloves-Specification
  • ASTM International (ASTM) standard D3577 (Standard Specification for Rubber Surgical Gloves), D3578 (Standard Specification for Rubber Examination Gloves), D5250 (Standard Specification for Poly(vinyl chloride) Gloves for Medical Application), or ASTM D3578 standard or equivalent standard for natural rubber latex
  • AS NZS 4011 Single-use medical examination gloves, Part 1: Specification for gloves made from rubber latex or rubber solution

Facemasks and gowns

Utility mask
Utility mask
A simple, flexible barrier that is placed over the nose and mouth during short exams and visitations, or during short procedures that do not produce fluid, spray or aerosols. Utility masks are not regulated as medical devices and are not recommended to provide protection from COVID-19.
Surgical mask
Surgical mask
A fluid-resistant, disposable device intended to be placed over the nose and mouth of medical personnel or patients who are infected or displaying symptoms, to create a physical barrier between the mouth and nose of the wearer and prevent the transmission of airborne organisms during surgery or patient examination. Surgical masks are graded as level 1, 2 or 3 based on the level of protection provided, or fluid resistance.
N95 respirator
N95 respirator

A filtering face piece respirator (FFR) that is designed to form a very close seal around the nose and mouth, protecting the wearer from exposure to airborne particles including pathogenic biological airborne particulates such as viruses and bacteria. N95 respirators have been tested for particulate filtration to ensure they remove a minimum of 95% solid and liquid aerosols that do not contain oil. N95 respirators are a single use item.

P2 respirators are also particulate filter respirators that provide similar protection from airborne or aerosol spread, but are designed, manufactured and tested to different, but comparable, standards.

For the purposes of reducing exposure to COVID-19 both P2 and N95 respirators can be used interchangeably.

Surgical N95/P2 respirator*
Surgical N95/P2 respirator

A filtering face piece respirator (FFR) with a similar structure and design to standard N95 respirators to protect the wearer from exposure to pathogenic biological airborne particulates, therefore meeting the same testing requirements for a minimum 95% filtration against airborne particulates.

Surgical respirators have also been tested for fluid resistance against penetration by synthetic blood under different pressures, such as may occur during certain high risk medical procedures.

Surgical Gown
Surgical Gown
A fluid-resistant, disposable garment made of natural and/or synthetic materials worn over a scrub suit to cover the arms, trunk, and upper legs, during a surgical procedure, to help protect both the patient and operating room personnel from the transfer of microorganisms, body fluids, and particulate material.
Goggles
Goggles
A personal protective device in the form of eyewear/glasses with clear lenses intended to be used to shield the eyes of healthcare staff from blood and other body fluid splashes while performing a clinical or laboratory procedure. It is designed as uncorrected (non-prescription) or corrected (prescription) goggles or spectacles with lenses and side shields. The lenses and side shields offer additional physical barrier protection.
Visors
Visors
A transparent personal protective device intended to shield the face and eyes of a healthcare worker from unnecessary exposure from blood and other body fluid splashes while performing a clinical or laboratory procedure. Visors are suitable for use with prescription lenses and protective masks.

*Note

The TGA is aware of recently identified issues with some filtering face piece respirators (FFRs) which claim compliance as KN95 respirators against the Chinese national standard for Respiratory Protection, GB 2626.

There are concerns they may not provide consistent and adequate respiratory protection based on testing conducted by National Institute for Occupational Safety and Health (NIOSH) - National Personal Protective Technology Laboratory (NPPTL) of the Centers for Disease Control and Prevention (CDC).

The TGA is currently undertaking a post-market review of all filtering face piece respirators (FFRs) and facemasks that are included in the Australian Register of Therapeutic Goods (ARTG). Further information is available on the post market review of face masks page.

Sterile medical devices

Please note that for any device that is supplied in a sterile state, the manufacturer must be able to provide evidence of sterility. Standards to help establish sterility can be found in Schedule 2 of the Therapeutic Goods (Conformity Assessment Standard for Quality Management Systems) Order 2019.

Supplying PPE in Australia

If your product meets the definition of a medical device and you intend to supply it in Australia, you will need to ensure your product is included in the ARTG before you import or supply your product. The following guidance aims to assist you with determining whether your PPE product is classed as a medical device and, if so, how your device is regulated.

Note

The sponsor of a medical device is the legal entity responsible for the importation and/or supply of the device within Australia. Sponsors must be an Australian based legal entity.

If you are supplying PPE in Australia we recommend you take the following steps to ensure you meet your obligations under the legislation:

  1. Determine whether your product is a medical device that requires inclusion in the ARTG. As noted above, non-sterile PPE or safety apparel that is intended to be used for the prevention of the transmission of disease between people meets the definition of a medical device.
  2. If your product meets the definition of a medical device, and needs to be included in the ARTG before you supply it, you will need to check the classification of the device as there are different regulatory requirements depending on the device's classification. PPE is generally classes as a Class I medical device. If your product is supplied in a sterile state, it will be classed as Class Is (sterile).

Note

The guidance below for including a medical device is a summary only. The full guidance for including a medical device in the ARTG can be found on our website at Medical device inclusion process.

Class I non-sterile, non-measuring

Class I sterile (and above)

Complete an organisation details form and submit it to eBS@health.gov.au. This will allow you to become a client of the TGA.

You will be given a username and password in order to access our online eBusiness portal. The portal allows you to submit applications for medical devices to be included in the ARTG.

Complete an organisation details form and submit it to eBS@health.gov.au. This will allow you to become a client of the TGA.

You will be given a username and password in order to access our online eBusiness portal. The portal allows you to submit applications for medical devices to be included in the ARTG.

Ensure that your manufacturer has:

  • applied an appropriate conformity assessment procedure to the device;
  • has evidence demonstrating that the device complies with the Essential Principles; and
  • has a system for post-market monitoring and taking corrective action in please.

If your manufacturer has met these conditions, please have them complete a Declaration of Conformity for your device.

Ensure that your manufacturer has:

  • applied an appropriate conformity assessment procedure to the device;
  • has evidence demonstrating that the device complies with the Essential Principles;
  • has a system for post-market monitoring and taking corrective action in please; and
  • has been audited by a conformity assessment body or comparable overseas regulator.

Information about the kind of evidence/documentation that you can use can be found in Table 2 on the TGA website at Information that must accompany ARTG inclusion applications for the purpose of passing preliminary assessment.

Once you have received your client logon details, log into the TGA Business Services online portal and submit an application for your device to be included in the ARTG.

Guidance to assist you with this process can be found on our website at Step 4 - Submitting an application in TBS for Class I non-sterile, non-measuring and Class 1 IVD medical devices.

Once you have received your client logon details, log into the TGA Business Services online portal and submit a Manufacturer's Evidence application.

There are no charges or fees associated with submitting this application.

Note: If your manufacturer is new to the TGA you will need to lodge their details. This can be done using the New Manufacturer function in the Manufacturer Evidence form.

You will receive an invoice for $540 which you can view and pay for through the TBS portal.

Once you have received notification that the Manufacturer's Evidence has been accepted by the TGA, log into the TGA Business Services online portal and submit an application for your device to be included in the ARTG.

Guidance to assist you with this process can be found on our website at Step 4 - Submitting an application in TBS for Class I non-sterile, non-measuring and Class 1 IVD medical devices.

Your application will be automatically approved as soon as you pay for your invoice and this is receipted by the TGA.

You will receive notification of your inclusion in the ARTG within a day of the payment being receipted.

You will receive an invoice (for Class I sterile the application fee is currently $1040) which you can view and pay for through the TBS portal.

Once you have paid the application fee, the TGA will commence processing your application.

Note: Our servers replicate information overnight. You may not be able to view your inclusion in the ARTG or access your ARTG certificate until the day after you pay for your application.

Please allow four (4) business days from the time you submit your payment before you contact the TGA to check the status of your application.

You do not need to contact the TGA to ask that your application is expedited - our assessors will automatically process your application as an urgent priority.

We will be in contact with you if we require more information to support your application.

Once your device is included in the ARTG, you will have ongoing responsibilities including:

Note

The TGA is prioritising and expediting all COVID-19-related assessments, reviews, and responses to queries. More information is available at TGA response to coronavirus (COVID-19).