The Therapeutic Goods Administration (TGA), the Australian regulating authority in the sphere of healthcare products, has announced a public consultation on proposed amendments to the regulatory framework for medical devices that are substances introduced into the human body via a body orifice or applied to the skin. The present document constitutes the initial version of the consultation paper published by the authority in July 2021.
According to the document, the process of improvement of the regulations for medical devices composed of substances that are intended to be introduced into the human body through a body orifice, or applied to the skin, and are absorbed or dispersed was initially commenced earlier in 2019 when the appropriate consultation dedicated to new classification rules for such devices took place. As stated by the TGA, there is an intent to align national legislation on the matter with the respective rules and regulations adopted in the European Union in order to improve public health protection and facilitate the regulatory procedures associated thereto.
According to the feedback received by the authority, the parties involved in operations with such devices mostly supported the new regulatory approach suggested by the TGA. Later in December 2019, the Therapeutic Goods Legislation Amendment (2019 Measures No.1) Regulations 2019 were adopted in order to implement the changes discussed. In particular, under the amendment, new classification rules have been introduced for medical devices composed of substances that are intended to be introduced into the human body through a body orifice or applied to the skin. The new rules should become applicable starting from November 25, 2021.
New Classification Rules
According to Subclause 3.1(4) of Schedule 2:
(4) If a device is composed of substances, or combinations of substances, that are:
(a) intended to be:
(i) introduced into the human body through a body orifice; or
(ii) applied to the skin; and
(b) absorbed by, or locally dispersed, in the human body after introduction or application;
the device is classified as follows:
(c) if the device, or its products of metabolism, are systematically absorbed by the human body in order to achieve the intended purpose – Class III;
(d) if the device achieves its intended purpose in the stomach or lower gastrointestinal tract and the device, or its products of metabolism, are systematically absorbed by the human body – Class III;
(e) if the device is applied to the skin, or in the nasal or oral activity as far as the pharynx, and achieves its intended purpose on those cavities – Class IIa;
(f) in any other case – Class IIb.
The authority also states that the aforementioned classification rule is aligned with EU Medical Devices Regulation 2017/745 (MDR), rule 21 of Chapter III of Annex VIII.
However, the TGA also acknowledges that the actual application of a new regulatory approach could result in situations when a product would simultaneously meet the definition of a medical device and a medicine. Consequently, both regulatory frameworks would formally be applicable.
In order to assist the parties involved in applying the provisions described herein, the authority also provides the definitions of the most important terms and concepts used in the context of medical devices composed of substances that are intended to be introduced into the human body through a body orifice, or applied to the skin. In particular, the document provides the definitions of medicine, which stands for a product that actives its intended purposes by pharmacological, chemical, immunological or metabolic means in or on the body of a human; while a medical device does not achieve its intended purpose by the abovementioned means, even when they could be assisted by them. Thus, the main criteria to be applied to distinguish medicines and medical devices is based on the primary mode of action – the day the product achieves its intended purpose as set forth by the manufacturer.
Suggested Amendments in Detail
As mentioned, the initial intent was to align the national legislation on medical devices with the respective rules and regulations adopted in the EU. However, in this particular case, such an alignment results in a regulatory overlap for certain products. The TGA mentions that according to the general principle of alignment, which states that an alignment should take place “where possible and appropriate,” in this case, an alignment should not take place. Thus, in order to avoid an overlap in regulatory frameworks as described above, the TGA recommends repealing provisions (c) and (d) – the ones dedicated to products that are systematically absorbed by the human body, as products achieving their intended purpose by such means are already covered by medicines regulations. In this way, the authority will avoid confusion arising when the same product falls within the scope of the two different regulatory frameworks.
The document further provides some examples of medical products the new approach relates to in order to demonstrate the difference between the regulatory frameworks applied. These examples include the following:
1.Saline nasal solution spray, which was a Class I invasive medical device under the previous framework, and is a Class IIa medical device according to the new classification rules. The authority additionally emphasizes the following: if such a product contains only isotonic saline, it should be treated as a medical device, but if it contains hypertonic saline with any other effect, it should be subject to regulation under the medicines framework.
2.Anti-snoring devices were initially classified as Class I invasive medical devices for short-term use, and under the new rules, they are Class IIa medical devices. However, according to the amendment, the medicine/medical device determination should depend on the intended purpose and mode of action of the particular product in question.
3.Skin moisturizer or barrier dressing were initially classified as Class I non-invasive medical devices. Now they should be treated as Class IIa medical devices applied to the skin. At the same time, since they could be absorbed after application, the particular regulatory approach to be applied should be determined depending on the mode of action: if the product only creates a barrier, it should be regulated as a medical device, but if it also provides certain skin treatment, it should fall under the medicines framework instead.
According to the guidance, the products covered by its scope would be regulated as either over-the-counter (OTC) medicines or Class III medical devices. Under the general rule, the following registration timelines should be applied:
- For OTC medicines – from 150 to 210 business days;
- For Class III medical devices – 60 business days.
In summary, the present TGA consultation paper describes the new classification rules for medical devices and addresses the regulatory issues associated thereto. The regulating authority suggests the way the potential collision could be treated and encourages all the parties involved to provide their feedback and suggestions on the matter.
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