TGA approved therapeutic goods, devices and software

Introduction

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)

DISCLAIMER: this is NOT legal advice, the regulations are more complex and nuanced than this quick and very brief summary

Excluded goods which can be used without TGA approval

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

Classification of TGA approved medical devices

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

an ARTG entry applies to a specific sponsor (an individual or company) - if the same or similar product is imported or supplied by another sponsor it is considered unapproved.
- a new TGA application must be made if either:¹⁾
  - new manufacturer
  - new device nomenclature system code
  - new classification
  - new unique product identifier (for certain classes of medical devices)
  - new formulation, dose, name, indication, direction for use, type of container for a medicine

Clinical use of unapproved non-excluded devices

Temporary exemptions during supply shortages

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

Authorised Prescribers

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

Research / clinical trials purposes

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

Emergency use

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

Potentially illegal use

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