Australia: Critical Medical Device Reclassification

ARQon
May 6, 2022
3 min read

In November of 2021, the Therapeutical Goods Administration (TGA) released the “Reclassification of medical devices that are substances introduced into the human body via a body orifice or applied to the skin”. This document states that medical devices that are substances for introduction into the body will be required to meet regulatory requirements demonstrating the safety and performance for Class IIa (low-medium risk) or Class IIb (medium-high risk) devices.

Medical devices that are substances for introduction into the body

Medical devices that are substances, or a combination of substances, that are introduced into the body through an orifice or the skin, and are absorbed or locally dispersed include the following products:

Saline solution nasal spray
Lozenges that only exert their effect in the mouth cavity
Denitrifies for sensitive teeth
Resin-based dental materials applied to the tooth surface
Some wart removers
Gels for vaginal discomfort (not including anti-fungal or antimicrobial chemicals)
Wound protection gels and creams to treat or prevent minor skin irritations
Products for topical use such creams, gels or ophthalmic solutions
Weight loss capsules that expand in the stomach to create a feeling of satiety and are not intended to achieve their action in the body by pharmacological, immunological, or metabolic means.

Products that are medicines On the other hand, substances that are introduced into the body through as orifice or the skin that have pharmacological or metabolic effects on the body are characterized as medicine and not medical devices. Examples include:

Salivation simulation lozenges
Sodium alginate based-products for reflux
Gastrointestinal gas suppressant
Mineral-based gastrointestinal detoxifier Device reclassification When classifying medical devices with components entering the body through a body orifice or the skin, manufacturers should consider:
How is the substance introduced into the body?

Through a body orifice, the surface of the eyeball or the surface of the skin, etc.

Where in the body does the substance achieve its intended purpose or action?

In the stomach or gastrointestinal tract, in the nasal or oral cavity, on the skin, etc. Some products that are locally dispersed in the nasal or oral cavity are typically retained within, and primarily act within, that area of the body.

Once the substance is introduced into the human body and achieves its intended purpose or action, is it absorbed by the body and metabolized and/or excreted from the body?

Some products may be absorbed systemically via the mucous surfaces of the digestive tract but are then transported into the bloodstream to be metabolized in the liver and excreted from the body, these would be considered medicines.

The higher classification is due to the fact that, the effects these substances may have once absorbed or circulated around the body may not be easily reversed or stopped if not performing as intended. Other factors such as level of invasiveness and potential toxicity of devices should also be considered when determining accurate classifications. For sponsors/manufacturers/distributors of medical devices made up of substances to be introduced into the body through an orifice or the skin surface, the required actions is determined by the status of the particular project:

Medical devices included in the ARTG prior to 25 November 2021
Applications to include a medical device in the ARTG lodged before 25 November 2021
Applications to include a new medical device in the ARTG on or after 25 November 2021

Sources Reclassification of medical devices that are substances introduced into the human body via a body orifice or applied to the skin