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Personal protective equipment

Products like medical gloves, surgical masks, gowns and other protective equipment are regulated as medical devices when they serve a therapeutic purpose.

An overview of personal protective equipment

Start here to get an overview of how your product is regulated and helpful information to support your journey.

Regulation of personal protective equipment

Know your obligations at each point along your product’s regulatory journey.

  • Icon - manufacturing

    Manufacturing

    Search guidance and other information on manufacturing for personal protective equipment (PPE).

  • icon - application and market authorisation

    Application and market authorisation

    Guidance and other information on the application process, including evaluation processes and fees, for personal protective equipment (PPE).

  • icon - supply and distribution

    Supply and distribution

    Find requirements for the ongoing supply, import, export, storage and handling of personal protective equipment (PPE).

  • icon - labelling and advertising

    Labelling and advertising

    Information about labelling, packaging and advertising for personal protective equipment (PPE).

  • icon - monitoring and compliance

    Monitoring and compliance

    Understand your ongoing post-market responsibilities for personal protective equipment (PPE).

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