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 in the Australian Register of Therapeutic Goods (ARTG); and
- 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;
- The overview of the post-market review of face masks; and
- Face masks and COVID-19.
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 in 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 in 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:
- The Therapeutic Goods Act 1989 (the Act)
- The Therapeutic Goods (Medical Devices) Regulations 2002 (the Regulations)
- The Therapeutic Goods Regulations 1990
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 may be demonstrated by showing that your product meets an applicable standard. Refer to our guidance on medical/surgical face masks and respirator standards - key performance aspects
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
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).
The requirement to hold evidence of compliance/certification is applicable for all standards including listed below in relation the specified labelling. When a manufacturer nominates conformity to a standard, it is expected they would have conformed to all requirements of the standard, and any exclusions should be noted.
Surgical masks and respirators
This video provides manufacturers and suppliers technical information on face masks and respirators that are regulated as medical devices.
- 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 - 20 Standard Specification for Performance of Materials Used in Medical Face Masks
- U.S. National Institute of Occupational Safety and Health (NIOSH) 42 CFR Part 84 Respiratory Protective Devices (in relation to products labelled with N-, R- and P- classification at 95, 99 and 99.9% filter efficiency)
- 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 (in relation to products labelled with P2/P3 class filter efficiency)
- EN 149:2001 + A1 Respiratory protective devices- Filtering half masks to protect against particle - Requirements, testing, marking (in relation to products labelled with FFP2 and FFP3 classification)
- GB 2626-2019 Respiratory protective equipment - Non-powered air-purifying particle respirator (in relation products labelled with theto filter element grades types KN and KP 90/95/100 filter elements)
- EN 14683:2019 Medical face masks - Requirements and test methods
- GB 19083:2010 Technical requirements for protective face mask for medical use
Note
AS/NZS 1716:2012 'Respiratory protective devices', the standard for P2 respirators, and the NIOSH standard 42 CFR Part 84 for N95 respirators can be used as functional standards for both medical devices and for respirators that are not medical devices.
Standards Australia has released a statement in relation to the adoption of the ISO 16900 series of standards for Respiratory protective devices and in relation for the transitions period for withdrawal of AS/NZS 1716:2012. Manufacturers are encouraged to keep informed of changes to relevant standards. Typically, application of a currently adopted standard is considered a minimum benchmark for applying solutions having regard to the generally acknowledged state of the art. Application of superseded standards is generally not acceptable. Manufacturers should consider how they will transition standards as they change and consider risk management activities, such as a gap analysis to understand any potential impacts.
Use of 'N95' as a descriptor for respirators
The TGA considers the descriptors 'N95' 'N99' and 'N100' to be a specific labelling claim where a device demonstrates conformity to NIOSH requirements against the United States Federal regulation for certifying air-purifying particulate respirators known as 42 Code of Federal Regulations Part 84 (or 42 CFR Part 84), or any national or international standard that specifies this designation.
The TGA expects, if a product is labelled N95, the manufacturer will hold evidence of NIOSH approval, or have quality control processes, and performance test data including results and conclusions to demonstrate the applicable requirements of 42 CFR Part 84 have been met. Requirements for quality control are set out in subpart E of 42 CFR Part 84. The tests should be performed by an accredited laboratory demonstrating performance against key 42 CFR Part 84 requirements, including subparts H through KK criteria. Subpart K is the part most relevant for most N95 respirators. These are an extensive list of design, performance and test requirements required as part of the NIOSH approval process.
If a manufacturer has not obtained certification and only has test reports to demonstrate compliance with the 95% particulate filtration component of the standard, then this is not sufficient to be designated as an 'N95' respirator; the labelling should only state >95% particulate filtration.
Surgical and Isolation gowns
- ANSI/AAMI PB70: 2012, 'Liquid barrier performance and classification of protective apparel and drapes intended for use in health care facilities.'
- ASTM F3352 - 19, Standard Specification for Isolation Gowns Intended for Use in Healthcare 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 F1670 Test Method for Resistance of Materials Used in Protective Clothing to Penetration by Synthetic Blood
- ASTM F1671 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
- SO 16603:2004 - Clothing for protection against contact with blood and body fluids - Determination of the resistance of protective clothing materials to penetration by blood and body fluids - Test method using synthetic blood
- ISO 16604:2004 Clothing for protection against contact with blood and body fluids - Determination of resistance of protective clothing materials to penetration by blood-borne pathogens - Test method using Phi-X 174 bacteriophage
- EN 13034:2005 Protective clothing against liquid chemicals. Performance requirements for chemical protective clothing offering limited protective performance against liquid chemicals
- ISO 13994:2005 Clothing for protection against liquid chemicals - Determination of the resistance of protective clothing materials to penetration by liquids under pressure
- EN 14126 Protective clothing against infective agents
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
Sterile medical devices
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, with specific reference to Item 1 of Schedule 1 to the Therapeutic Goods (Medical Devices - Specified Articles) Instrument 2020, 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:
- Determine whether the manufacturer intends that 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.
- If your product, in accordance with the intended purpose defined by the manufacturer, 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:
If your manufacturer has met these conditions, please have them complete a Declaration of Conformity for your device. You must submit the Declaration of Conformity with your application. | Ensure that your manufacturer has:
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 $550 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 either be included on the ARTG or selected for non-mandatory audit. | You will receive an invoice (for Class I sterile the application fee is currently $1060) 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. |
| If your application is not selected for a non-mandatory audit, and is included in the ARTG, you will receive notification within 4 business days of the payment being receipted. We will be in contact with you if we require more information to support 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).
For more information about face masks visit Face masks and COVID-19.
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