The Therapeutic Goods Administration (TGA), the Australian regulating authority in the sphere of healthcare products, has published guidance on reclassification of medical devices that administer medicines or biologicals by inhalation. The document falls within the scope of the general reclassification of certain medical devices announced earlier by the TGA. The present document constitutes the initial version of the guidance.
The guidance is intended to provide medical device manufacturers and other parties involved in manufacturing medical devices and placing them on the market with additional clarifications on the applicable regulatory requirements and also the recommendations to be considered. However, the provisions of the document are non-binding in their legal nature, so in the case of any discrepancies with the applicable provisions of the current legislation, the latter shall prevail. Additionally, the TGA reserves the right to amend the guidance from time to time in order to reflect changes that occur to the regulatory framework.
The document provides additional clarifications regarding the transition to the new regulatory requirements for medical devices that administer medicines or biologicals by inhalation. According to the guidance, starting November 25, 2021, such devices should be assigned to the higher class under the Australian medical device risk-based classification, namely, to Class IIa or Class IIb. Thus, an interested party intending to place such devices on the market shall provide sufficient evidence demonstrating compliance with the applicable regulatory requirements in terms of safety and performance.
The reclassification process was initially commenced in 2019 when the authority announced a public consultation on the matter. The suggested reclassification of certain medical devices was supported by industry representatives and other parties involved in the public consultation, so the new regulations based on the feedback collected by the TGA have been developed. The scope of changes to be implemented under the new regulation covers the reclassification of medical devices that administer medicines or biologicals by inhalation.
Changes to the Regulatory Requirements
As a consequence, the medical devices in question will be subject to a rigorous assessment before being approved for marketing and use in Australia. Additionally, an interested party (a sponsor) will have to provide sufficient evidence demonstrating the medical device complies with any and all applicable regulatory requirements. The present document provides recommendations to be considered in order to achieve and sustain compliance with the applicable regulatory requirements.
Starting on the date indicated above, the following classification rule should be applied:
Subclause 3.1(2A) of Schedule 2:
(2A) If the device is intended to be used to administer medicines or biologicals by inhalation:
(A) if the mode of action of the device has an essential impact on the efficacy and safety of the medicines or biologicals – the device is classified as Class IIb; or
(B) if the device is intended to treat a life-threatening condition – the device is classified as Class IIb; or
(C) if paragraphs (a) and (b) do not apply – the device is classified as Class IIa.
Additionally, the TGA provides some examples of medical devices subject to reclassification under the new rule. The guidance also outlines the main aspects to be considered when determining the appropriate class of a medical device under the amended Australian medical device classification, namely:
- The extent to which the mode of action of a medical device in question impacts the medicine or biological it is intended to administer in terms of its safety and effectiveness.
- The intended purpose of a medical device – whether it is related to the treatment of a life-threatening condition.
If any of the points above are applicable, such a medical device should be classified as a Class IIb product, and the appropriate regulatory requirements should be applied accordingly.
The examples of invasive medical devices intended for administering medicines or biologicals that fall within the scope of reclassification include the following:
- Inhalation accessory devices (e.g., spacer / valved holding chambers/face masks);
- Accessories to nebulizers (e.g., mouthpiece, nebulizers cup/container, tubing);
- Nasal oxygen cannula;
- Endotracheal tube;
- Laryngeal mask airway / laryngeal mask;
- Oropharyngeal airway;
- Nasopharyngeal airway;
- Refillable inhaler device.
The authority additionally emphasizes that the medical devices listed above are usually supplied separately as independent medical devices.
Some of the products used for administering medicines or biologicals are not medical devices from a regulatory standpoint. According to the Therapeutic Goods (Articles that are not Medical Devices) Order No. 1 of 2010, the following products fall outside the scope of medical device regulations: “an article that is intended to administer a medicine in such a way that the medicine and the article form a single integral product which is intended exclusively for use in the given combination and which is not reusable (maybe multi-dose)”.
The authority states that the manufacturers producing device components thereto are not obliged to comply with the medical device regulations. The products falling within the scope of such exclusion include certain pressured metered-dose inhalers (pMDIs) and multi-dose dry powder inhalers (DPIs). For instance, this applies to such devices as:
- Metered-dose inhalers pre-filled with the medication. This category includes devices intended to administer a pre-measured dose of aerosolized medication and composed of a holder with a mouthpiece and a pressured metal canister in which the medicine is contained.
- Dry powder inhalers pre-filled with the medication. This category includes medical devices intended to administer powdered medicine. The device of such type requires inspiratory flow to ensure the delivery since it is a breath-actuated device and does not contain additional technical elements intended to facilitate the administration of dry powder through the mouth into the bronchial airways.
The new changes to classification rules described herein will not impact the regulatory status of such products, and they will continue to stay outside the framework of the medical device.
Further Actions to be Taken
The actions the responsible entity shall take will depend on the status of the medical device in question. The document states there are three potential pathways, namely:
- For medical devices already included in the Australian Register of Therapeutic Goods (ARTG) before the new rules take effect;
- For current applications submitted before the new classification rules take effect; and
- For applications related to the brand new medical devices to be submitted on or after the effective date of the new classification rules.
In the case of medical devices that administer medicines or biologicals by inhalation that are already registered in the ARTG and placed on the market, such devices will be subject to regulation under the special transitional regime framework allowing the manufacturer to market the product during its re-inclusion in the register under the new rules in order to avoid shortages and ensure uninterrupted availability.
In this regard, the responsible entity shall:
- Inform the regulating authority about the products falling within the scope of reclassification rules – before May 25, 2022; and
- Apply for inclusion in the register under the new classification rules – before November 1, 2024.
In summary, the present guidance describes the way the new classification rules should be applied in the case of medical devices that administer medicines or biologicals by inhalation. The document also outlines the particular actions to be taken by the medical device manufacturer or other entity responsible for a medical device in order to ensure compliance with the regulatory requirements in the context of changes to the applicable classification rules.
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