From 25 November 2021, 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. In considering the appropriate classification for medical devices composed of substances that are introduced into the human body through a body orifice or the skin, sponsors should consider the following:

1. (1) How is the substance introduced into the human body?

For example, through a body orifice, the surface of the eyeball, or the surface of the skin.

1. (2) Where in the body does the substance achieve its intended purpose or action?

For example, in the stomach or gastrointestinal tract, in the nasal or oral cavity, on the skin. 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.

1. (3) Once the substance is introduced into the human body and achieves its intended purpose or action, is it absorbed by the body and metabolised and/or excreted from the body?

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

 

These products may present a higher level of risk as once the substance is absorbed or dispersed in the body its effects may not be easily reversed or ceased if they do not perform as intended. It is important that these factors are considered when evaluating the safety and performance of these products. Other factors such as the level of invasiveness and potential toxicity of devices introduced into the human body should also be considered when applying the relevant classification rule.

 

Medical devices that are composed of substances, or combinations of substances, that are introduced into the human body through a body orifice, or applied to the skin, and are absorbed by or locally dispersed in the human body may include the following products, depending on how it exerts its effect within the body:

• •  saline solution nasal sprays
• •  lozenges that only exert their effect in the mouth cavity
• •  dentifrices 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 as 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.

 

If you are the sponsor of a medical device composed of substances that are intended to be introduced into the human body through a body orifice or applied to skin, the actions you will need to take to comply with the new regulations will depend on the status of your product. If you have a medical device composed of substances that are intended to be introduced into the human body through a body orifice or applied to skin in the ARTG (Australian Register of Therapeutic Goods) with a start date before 25 November 2021, transitional arrangements are in place to ensure that you can continue to supply your device while you apply for it to be included in the ARTG in accordance with the new classification.

 

To continue to supply your device, you must notify the TGA before 25 May 2022 that you have an ARTG inclusion that will need to be reclassified, and you can submit an application for your device to be included in the ARTG under the correct classification before 1 November 2024.

 

On the other hand, if you have submitted an application for inclusion in the ARTG for a medical device composed of substances that are intended to be introduced into the human body through a body orifice or applied to skin before 25 November 2021, your device application will be assessed and the device will be included in the ARTG under the old classification rules. To be eligible for the transitional arrangements to reclassify your device under the new classification rules, you must notify the TGA that your device of ARTG inclusion needs to be reclassified before 25 May 2022, or within two months of inclusion of your device under the old classification rules, whichever is the later date, and then submit an application for your device to be included in the ARTG with the correct classification before 1 November 2024.

 

If you have not notified the TGA that your device needs to be reclassified before 25 May 2022, or within two months of inclusion of your device under the old classification rules, whichever is the later date), it is required to cease supply of your devices from 25 May 2022 or the date that is 2 months after the start date of your ARTG entry, whichever is the later date. And if you have not submitted an application for inclusion in the ARTG to transition your device to the correct classification before 1 November 2024, it is necessary to cease supply of your devices from 1 November 2024.

 

 

References:

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

Notification form: Reclassification of medical devices that are substances for introduction into the body