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.
Overview of the regulation of PPE
Under the Therapeutic Goods (Declared Goods) Order 2019 the following products are declared to not be therapeutic goods:
Non-sterile protective or safety apparel or equipment when used:
- in the home; or
- for occupational or recreational use.
This means that non-sterile PPE including masks, gowns and gloves that do not make any therapeutic claims are regulated as general consumer items and do not need to be included on the Australian Register of Therapeutic Goods (ARTG) before they can be supplied.
PPE including masks, gowns and gloves that are presented or claim to be for therapeutic use, such as surgical or examination masks intended to reduce or prevent the transmission of disease or micro-organisms (such as bacteria or viruses), meet the definition of a medical device. These products are regulated by the TGA under the Therapeutic Goods Act 1989 and will need to be included on the ARTG before they can be supplied.
PPE that meets the definition of a medical device therefore needs to be included in the ARTG will generally be regulated as either:
- a Class I medical device;
- a Class Is (sterile) medical device; or
- a Class IIa medical device.
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 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
- 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
- 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 respirator P2 and N95 masks is not a standard for 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
-
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
-
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
-
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
-
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
-
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
-
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
-
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.
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:
- Determine whether your product is a medical device that requires inclusion in the ARTG. As noted above, PPE intended for use in a clinical setting, or that makes therapeutic claims, meets the definition of a medical device.
- 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 |
