Reclassifying medical devices that are substances introduced into the body or applied on the skin

In early 2019 Therapeutic Goods Administration (TGA) conducted a public consultation seeking feedback on a proposal to introduce new classification rules for medical devices composed of substances that are intended to be introduced into the human body through a body orifice, or applied to skin, that are absorbed or dispersed. The proposed regulatory changes supported the commitment made in the Australian Government Response to the Review of Medicines and Medical Devices Regulation to align Australian medical device regulations, where possible and appropriate, with the European Union framework.

Stakeholders who responded to the public consultation were broadly supportive of the proposed changes and the Therapeutic Goods Legislation Amendment (2019 Measures No.1) Regulations 2019 was made on 12 December 2019.

The amendments include the introduction of new classification rules for medical devices composed of substances that are intended to be introduced into the human body through a body orifice or applied to skin, to classify these devices as Class IIa (low-medium risk) or Class IIb (medium-high risk) effective from 25 November 2021.

A further consultation was undertaken in July 2021, with regulatory refinements made on 29 October 2021 to provide greater clarity around the regulation of these products.

Requirements for reclassification 

The requirements include:

• conformity assessment documents demonstrating procedures appropriate for a Class IIa or 
  Class IIb medical device.
• more detailed assessment of the manufacturer’s quality management systems and assessment of technical documentation related to each device. 

Medical devices that are composed of substances, or combinations of substances, that are introduced into the human body through an orifice (and are locally dispersed in the human body), or applied to and absorbed by the skin, may include the following products, depending on how they exert their effect within the body: 

• isotonic saline solution nasal sprays
• non-medicinal lozenges that only exert their effect in the mouth cavity
• some wart removers (not intended to achieve their action by pharmacological, immunological, or metabolic means)
• gels for vaginal discomfort (not including anti-fungal or antimicrobial medicines)
• wound protection gels and creams (that are absorbed but are not medicines) to treat or prevent minor skin irritations
• products for topical use such as creams, gels, or ophthalmic solutions such as eye lubricants that do not contain a medicine. Note that dyes and stains for diagnostic purposes are considered medicines, such as for identification of a corneal lesion or a sentinel lymph node. Dyes and stains (that do not contain a medicine) for identification of normal anatomy are considered devices such as surgical marker pens
• 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.

Only those products composed of substances or of combinations of substances that meet the definition of a medical device are regulated as medical devices.

Some products may also fall under the definition of a medicine. These products are so called borderline or boundary products (when it may not be clear whether a given product is a medical device or a medicine). Many products that have been represented as medical devices in other jurisdictions are considered medicines in Australia, as their mechanism, including a chemical effect in or on the human body can be characterised as pharmacological, metabolic or immunological and is therefore inconsistent with the definition of a medical device.

The regulatory pathway (medical device or medicine) for such products is determined based on the product’s primary mode of action, intended use and the manufacturer’s claims made regarding the product’s performance, based on the analysis and scientific evidence. The impact or effect the product may have or any other secondary intended purpose and dose administered should also be taken into account.

From 25 November 2021, the following classification rules will apply:

Clause 5.11 of Schedule 2 - Medical devices that are substances to be introduced into the body or applied to and absorbed by the skin

If a medical device is composed of substances, or combinations of substances, that are intended to be:

(a)  introduced into the human body through a body orifice; or
(b) applied to and absorbed by the skin;
the device is classified as follows:
(c)  if the device is introduced into the nasal or oral cavity as far as the pharynx, or is applied to and absorbed by the skin, and achieves its intended purpose in that cavity or on the skin—Class IIa;
(d) in any other case—Class IIb.

As per clause 5.1 of Schedule 2, a medical device that incorporates, or is intended to incorporate, as an integral part, a substance that if used separately would be a medicine; and is liable to act on a patient’s body with action ancillary to that of the device, is regulated as a Class III medical device. 

Examples of devices to be reclassified

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:

• How is the substance introduced into the human body? For example, through a natural body orifice, a permanent artificial orifice (e.g., a stoma), the surface of the eyeball, or the surface of the skin. The reference to the pharynx in the classification rule refers only to the mouth, not other body orifices.
• What happens to the substance after it is introduced? For example, the classification rule is not intended to apply to devices that are generally not locally dispersed, such as tongue depressors, dental impression material or endoscopes.
• For substances applied to the skin, is it absorbed by the body? For example, some products may not be absorbed via the skin whilst others may be absorbed. If the product is not intended to be absorbed by the skin, you may be required to provide evidence that the product is not absorbed. Generally, products which achieve their intended purpose via systemic absorption through the skin are regulated as medicines, as they tend to act via pharmacological, immunological or metabolic means. Devices with a barrier function that are not absorbed do not fall within scope of this regulation.

Products which are absorbed may present a higher level of risk as their 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. The level of invasiveness of devices introduced into the human body should also be considered when applying the relevant classification rule.

Some examples of medical devices that may be substances/combinations of substances, with a comparison of the old classification versus the new classification and clarification of appropriate regulatory pathways are provided below.

Exceptions

Sterile saline eye irrigation solutions intended to act on the surface of the eye to flush the eye of irritating particulates/chemicals will remain classified as Class I sterile medical devices.

Topical nail treatment solutions designed to treat infected nails (for example, in the case of onychomycosis) and nail-growth disorders (onychodystrophy) by creating a barrier to microorganisms with no antibacterial or antifungal ingredients, will remain classified as Class IIa medical devices; products containing ingredients with antibacterial and/or antifungal action are not medical devices and are regulated as medicines.

Dentifrices which are intended for cleaning the surfaces of teeth and which do not contain any substances included in Schedules 2, 3, 4 or 8 of the Poisons Standard, are not regulated as medical devices. Further details are available at Therapeutic Goods (Excluded Goods) Determination 2018.

Chemical substances that are introduced into the human body through a body orifice or the skin and have a pharmacological, metabolic or immunological effect on the body as their principal mode of action are not medical devices and are characterised as medicines. Foods without therapeutic action are not therapeutic goods.

For example:

• Salivation stimulation lozenge – not a therapeutic good as the desired effect is a normal physiological response to food in the mouth that may be affected by flavour, noting that if there is any active ingredient that specifically stimulates salivation, the product is a medicine.
• Sodium alginate – is a medicine as it has a metabolic effect, altering the chemistry of gastric contents.
• Simethicone – is a medicine as it has a metabolic effect, altering the chemistry of gastrointestinal contents.
• Gastrointestinal detoxifiers – their action chelating compounds in the gut is a metabolic effect, hence these are medicines.

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:

• 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

Medical devices included in the ARTG prior to 25 November 2021

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 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.
• Submit a reclass application for your device to be included in the ARTG under the correct classification before the transition deadline.

If you do not intend to continue supplying the device, you should cancel your inclusion before 25 May 2022.

If you notify the TGA of your devices before 25 May 2022 but you do not submit an application for inclusion of your device in the ARTG with the correct classification before the transition deadline, you must cease supply of your device from the day of the transition deadline and cancel your ARTG inclusion.
 

Applications to include a medical device in the ARTG lodged before 25 November 2021

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 you have an ARTG inclusion that will need to be reclassified by whichever is the later date:
  –    Before 25 May 2022
  –    Within 2 months of the start date of your ARTG entry
• Submit a reclass application for your device to be included in the ARTG with the correct classification before the transition deadline.

Cancelling your ARTG inclusion

If you do not notify the TGA before 25 May 2022 or within two months of the start date for your ARTG entry (whichever is the later date) of your intention to apply for the device to be included in the ARTG under the new classification rules for your device, you will no longer be eligible for the transitional arrangements.

You should:

• cease supply of your device from 25 May 2022
• cancel your ARTG inclusion.

If you notify the TGA of your device before the due date, but you do not submit an application to include your device in the ARTG for the correct classification before the transition deadline, you must:

• cease supply of your device from the day of the transition deadline
• cancel your ARTG inclusion.

Applications to include a new medical device in the ARTG on or after 25 November 2021

Any application for inclusion of a new device that is not yet included in the ARTG, submitted to the TGA on or after 25 November 2021 must be submitted using the correct classification under the new classification rules.

For more information refer to the Medical device inclusion process.

Class IIa and Class IIb devices of the same kind

Class IIa and Class IIb devices are considered to be of the same ‘kind’ and can be included in one ARTG entry when they have the same:

• sponsor
• manufacturer
• classification
• Global Medical Device Nomenclature (GMDN) System Code.

For more information refer to the Medical device inclusion process.

Timeframes for reclassifying transitional ARTG inclusion 

To continue supplying your devices, you must submit your reclassification application for the correct class before the transition deadline. In November 2023, regulatory amendments have been made to extend the transition deadline for some transitional devices.

The updated transition deadline for devices that are substances introduced into the body via body orifice or applied to the skin is 1 July 2029. More information about the TGA’s strategy in response to EU MDR transition extension can be found at EU MDR transition extension.

If you have submitted your application before this date, but it has not yet been finalised by the TGA, you are able to continue to supply your devices using your existing ARTG entry until a decision is made about your reclass application.

How to submit a reclassification application

1. Create a ‘New Device Application’ from the menu in the eBS Portal
2. Select "Medical Device - Included" from the first drop down list provided.

3. Select the option to ‘Reclassify an existing register entry’.

4. Search for the ARTG Number to be reclassified: eg. 130099 (example only)

5. Select the "Clone" button.
6. Allow the system to clone the information associated with the ARTG entry into the application.
7. Select the correct classification under the new classification rules from the drop down provided for the “New classification” question.

If the GMDN code in the existing entry has been made obsolete or has been updated, the sponsor is responsible for selecting the most appropriate and current code available in the GMDN agency database.

If you are required to select a new GMDN code that is different to the cloned ARTG entry, you will not be able to validate and submit the application. Please save the draft application and email TGA Devices info line at devices@tga.gov.au for assistance. 

If there is a change of manufacturer, you must submit a new application (i.e. select “Create a new inclusion in the register” instead of “Reclassify an existing register entry” and provide information about the existing ARTG entry in the application form or in a supporting document attached with the form.

What to include in your application

• Applications for ARTG inclusion must be accompanied by appropriate conformity assessment documentation in order to pass preliminary assessment.
• The required documents are outlined in the final column "Documentation to be provided with the application (Evidence of product assessment)" of Table 2 in the Use of market authorisation evidence from comparable overseas regulators / assessment bodies for medical devices (including IVDs). If applicable, the evidence of product assessment must be provided in addition to the manufacturer evidence.
• Please ensure you allow sufficient time to obtain your conformity assessment documentation in order to submit your documents with your application. 

If you do not pass preliminary assessment, your application will be refused and you will not be able to transition your device to the new classification.

Fees

You will need to pay the relevant application fee.

Reclassification applications for Class IIa or IIb ARTG inclusions will not be subject to a mandatory audit.

However, TGA will select applications for non-mandatory audit if there are any concerns with the application (e.g. post market signals) or if there are minor changes in the submitted reclassification application. For example, if the information in the new application is not consistent with the information in the current ARTG entry (such as a rewording of the intended purpose).

Advertisements for medical devices that are directed to consumers are required to comply with requirements under the legislation. Guidance about the regulation of therapeutic goods advertising is available on our How to advertise page. 

If your inclusion application to transition your device to the new classification is not successful, you will be notified of the decision in writing and you will be provided the reasons for the decision.

If you are not satisfied with this decision, you may request reconsideration of this initial decision under section 60 of the Therapeutic Goods Act 1989 within 90 days of the decision.

If you are not satisfied with the reconsideration (reviewable decision), you may apply to the Administrative Review Tribunal or the court.

If you do not meet your obligations under the transitional arrangements, you will need to cease supply of your device.

The following table outlines the circumstances and timeframes.