Devices, equipment and physical barrier products

Devices and equipment that are used to assist in veterinary medical or surgical procedures, are chemically inert and act by physical rather than biochemical means, and make no claim other than that arising from their physical action, generally do not require registration.

Equipment that produces or emits sound, light or electromagnetic radiation does not require registration by the APVMA. Other government authorities regulate some of this equipment, including X-ray machines. However, if the equipment produces a substance that has a biochemical action—for example an antiseptic teat dip—the equipment would need to be approved as part of the approval for the substance it produces.

Examples of devices and equipment that don’t require registration are:

  • surgical instruments and equipment used to help perform surgical procedures that treat or prevent diseases or conditions (such as wounds)
  • non-medicated bandages used to support the musculoskeletal system or to prevent or treat injuries (such as wounds)
  • hoof repair resin or putty used for repairing defects in horses’ hooves
  • adhesive glue used for repairing wounds.

Physical barrier products and lubricants are substances that act principally by physical rather than biochemical means—therefore the APVMA, like other regulatory authorities, includes them with physical devices. As a further point of clarification, these products have been specifically excluded in the Agvet Code Regulations.

Barrier and lubricant substances do not require registration by the APVMA if they can be demonstrated that they:

  • are chemically inert or act principally by physical rather than biochemical means
  • are applied topically to animals
  • contain no antiseptic, antimicrobial, antibiotic or other active constituent
  • make no claim other than by their physical action.

The exception to the above are products used as teat sealants, which have been specifically included as veterinary medicines in the Agvet Code Regulations.

To be excluded from registration, products must only be applied topically to an animal and must not make any representation or claim on their label or other promotional material. They should not be represented as containing any active constituents on their labels or promotional material, and their label should contain a statement such as ‘Physical barrier product for topical application to animals’. Products that do not clearly identify themselves as physical barrier products may require registration.

Examples of physical barrier products used on animals that are excluded from registration include:

  • sunscreens that do not contain any astringent or other active constituent (such as zinc oxide) when represented only as being suitable for topical application to normal healthy intact skin to help protect skin from damage caused by UV sunlight
  • hoof-care and foot-care sealants, when represented only as being suitable for topical application to hooves or pads to seal in moisture, which may help reduce or prevent drying and cracking
  • polymer bandages, when represented only as being suitable for topical application to skin as a wound dressing to reduce or prevent contamination and to allow inflammatory exudates to remain in contact with a wound, which may help speed up natural healing
  • honey, when represented only as being suitable for topical application to skin as a wound dressing to reduce or prevent contamination and to allow inflammatory exudates to remain in contact with a wound, which may help speed up natural healing (and not represented as having an antimicrobial effect)
  • dental sealants, when represented only as being suitable for topical application to teeth or gums to reduce or prevent contamination, which may help reduce or prevent tartar or calculus
  • nasal sealants or protectants like cellulose, when represented only as being suitable for topical application to nasal passages to reduce or prevent contamination from dust or allergens
  • lubricants used in veterinary procedures, for example as an obstetrical lubricant (provided it doesn’t contain any active constituents)
  • eye protectant ointments, gels or drops for use in veterinary hospitals, when represented only as being suitable for topical application to eyes to protect them during anaesthesia or heavy sedation when the natural blink reflex is diminished (and not represented as helping in the treatment of keratoconjunctivitis sicca or ‘dry eye’).

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