Site notifications

Sub menu

 

 

An overview of personal protective equipment

Information about how therapeutic goods move through the regulatory lifecycle from early product development to post-market for personal protective equipment (PPE).

If you're planning to supply personal protective equipment (PPE) in Australia, this is your starting point.  
  

PPE like masks, gloves or gowns may be regulated as medical devices if they claim to prevent disease transmission between people, resist bodily fluids, or are used in healthcare. You’ll need to understand classification, prepare evidence, and meet standards.  
  

Start by learning your responsibilities and planning each step to meet Australian requirements and avoid application delays.  
  

You must meet certain obligations to legally supply therapeutic goods in Australia. This section contains guidance and information specific to medical devices. You may also have to meet obligations that apply to all medical devices and all products.  

General information

Learn about how products are regulated.

Definitions and classification

Understand how products are defined and classified.

Legislation, Acts and Orders

Review the laws and legal orders that regulate therapeutic goods.

  • Therapeutic Goods Regulations 1990

    Legislation
    These regulations provide requirements relating to the manufacturing, supply and advertising of therapeutic goods in Australia. These regulations also set out a number of important elements of the therapeutic goods regulatory scheme in Australia, including for instance specifying fees for applying for marketing approval for a therapeutic good or for a manufacturing licence, and setting out exemptions from the requirement for therapeutic goods other than medical devices to be included in the Australian Register of Therapeutic Goods (ARTG).

Standards and requirements

Understand product obligations for safety, quality and efficacy.

Product types