TGA approved therapeutic goods, devices and software

see also:

• https://www.tga.gov.au/products/medical-devices/overview
• https://www.tga.gov.au/resources/guidance/understanding-image-storage-and-transmission-software-exclusion
• Australian Register of Therapeutic Goods (ARTG)

• most therapeutic goods in Australia must be approved by the Therapeutic Goods Administration (TGA)
• therapeutic goods include:
  • medicines - includes prescription, over-the-counter and complementary medicines
  • biologicals - something made from or containing human cells or tissues, such as human stem cells or skin
  • medical devices includes certain software for clinical use (including AI-based solutions)

• see https://www.legislation.gov.au/F2018L01350/latest/text
• Schedule 1:
  • most personal use items including cosmetics, personal care items, consumer self-management software for conditions which are not serious
  • software designed for electronic health record, patient flow management, data analysis and NOT intended by the manufacturer to diagnose, screen for, prevent, monitor, predict, make a prognosis of, alleviate, treat, or make a recommendation or decision about treatment of a disease or condition
  • other exclusions
• Schedule 2:
  • various personal products including sunscreens with conditions
  • medical gases when installed in compliance
  • organs, eggs, etc for donation
• clinical decision support software (CDSS)
  • is software that helps health professionals (and is not directly targeting patients) make decisions about patient care
  • is NOT regarded as a medical device and hence excluded if
    • they are digitising what was previously a paper-based resource through an interactive software interface and they have no functionality beyond this.
    • the health professional uses information about their patient to decide which path to proceed, and how to use the resulting information or recommendations.
    • the software itself is not directly performing or providing recommendations consistent with any of the activities in the definition of a medical device.
    • eg. A web-based application that provides referenced information about particular diseases or conditions based on a health practitioner’s key-word search of a patient’s symptoms. The app does not indicate probability of a match/red flag or priorities.
  • may also be excluded if:
    • (a) is intended by its manufacturer to be for the sole purpose of providing or supporting a recommendation to a health professional about preventing, diagnosing, curing or alleviating a disease, ailment, defect or injury in persons; and
    • (b) is not intended to directly process or analyse a medical image or signal from another medical device (including an in vitro diagnostic device); and 
    • (c ) is not intended to replace the clinical judgement of a health professional in relation to making a clinical diagnosis or decision about the treatment of patients

• All devices must comply with six general "Essential Principles" - a further nine Essential Principles relating to design and construction apply to devices on a case-by-case basis
  • after a device is approved, the manufacturer must: 
    • continue to monitor the performance and safety of their device, and,
    • make sure it continues to comply with the Essential Principles.
• Class I
  • low risk eg. tongue depressors
  • Class I supplied sterile eg. surgical gloves
  • Class I measuring eg. medicine cup
• Class IIa
  • low-medium risk
  • eg. dental drills, ultrasound machines, digital or infrared thermometers
• Class IIb:
  • medium to high risk
  • eg. surgical lasers, diagnostic X-ray
• Class III:
  • high risk
  • Prosthetic heart valves
  • Absorbable surgical sutures
  • Hip prostheses
  • Pacemakers

• see https://www.tga.gov.au/resources/guidance/supplying-andor-importing-medical-devices-during-supply-disruptions-or-shortages

• specialist doctors can apply to become Authorised Prescribers²⁾ to treat multiple patients with a specific third party (eg. imported device) unapproved product without re-applying each time but must prove standard registered alternatives are unsuitable
  • doctor must gain informed consent from each patient for use of an unapproved device and accept full clinical responsibility for the use of the unapproved device as “unapproved therapeutic goods” have not been assessed by the TGA for quality, safety or efficacy
  • for a single patient, the Special Access Scheme can be utilized

• require:
  • approval of a Human Research Ethics Committee which³⁾
    • provides advice for trial protocol and design
    • weighs the risks and benefits of the therapeutic good
    • determines if your proposed clinical trial is ethical
    • approves the trial protocol
    • monitors the conduct of the trial
  • apply to TGA - via the Clinical Trial Application (CTA) scheme, or,
  • notify TGA - via the Clinical Trial Notification (CTN) scheme
• see https://www.tga.gov.au/products/unapproved-therapeutic-goods/access-pathways/clinical-trials/how-we-regulate-australian-clinical-trials-use-unapproved-therapeutic-goods

• in life or “limb” threatening time critical situations where access to an appropriate approved device is not available, it would seem reasonable that one could resort to a non-approved device if that action was reasonable in that situation
  • eg. surgical front of neck access in community settings - any knife and any plastic tube such as a Biro may be life saving
  • eg. emergency “off-label” use of intravenous needles to relieve a tension pneumothorax
  • eg. removal of constricting foreign bodies not able to be removed by approved devices

• use of an unapproved non-exempt therapeutic good without legal reason (as above), for example:
  • importation, provision or administration of unregulated peptides and similar substances is illegal
    • these peptides fall under Schedule 4 (Prescription-Only Medicine) of the Poisons Standard managed by the Therapeutic Goods Administration (TGA)
    • as therapeutic goods which require a valid prescription from a registered medical practitioner, they must be supplied by an authorized pharmacist, making direct-to-consumer online or social media sales illegal
  • clinical use of unapproved devices such as
    • unapproved thermal imaging device to assess skin temperature
    • unapproved spirometers