The new article provides an overview of the recent changes to the classification rules for certain medical devices.
The Therapeutic Goods Administration (TGA), an Australian regulating authority in the sphere of healthcare products, has published a guidance document dedicated to the reclassification of medical devices that administer medicines or biologicals by inhalation. The document provides additional clarifications regarding the transitional arrangements and obligations, as well as recommendations to be considered by medical device manufacturers and other parties involved in order to ensure compliance thereto. At the same time, provisions of the guidance are non-binding in their nature, nor are intended to introduce new rules or requirements. Moreover, the authority reserves the right to make changes to the guidance, should such changes be reasonably necessary to reflect corresponding changes to the underlying regulations.
In accordance with the new classification rules, from 25 November 2021 medical devices that administer medicines or biologicals by inhalation will be required to meet regulatory requirements demonstrating the safety and efficacy of the product commensurate with the higher classification (Class IIa or Class IIb).
As explained by the authority, public consultation has been conducted earlier in 2019 to receive feedback from industry representatives with respect to the proposed changes to the classification rules for specific types of medical devices. The said changes were broadly supported and later implemented by the virtue of the respective amendments taking effect from 25 November 2021.
According to the guidance, the new requirements for reclassification include:
- More detailed assessment of the manufacturer’s quality management systems and assessment of technical documentation related to the device;
- Conformity assessment documents demonstrating procedures appropriate for their classification.
The present guidance and recommendations provided therein are intended to assist medical device manufacturers in complying with the new requirements.
The changes to the classification rules described in the document apply to medical devices intended to administer medicines or biologicals by inhalation. Such products are commonly used in the context of respiratory disorders, however, the authority acknowledges that nowadays they are sometimes used for non-respiratory conditions as well.
According to the guidance, when determining the regulatory status of the product and classification to be applied, the following factors should be taken into consideration:
- Does the mode of action of the device have an impact on the delivery, dosage, efficacy and safety of the medicine or biological that is being delivered to the person?
- Is the device intended to administer a medicine or biological by inhalation to treat a life-threatening condition where, if the operation of the device failed it could result in the serious injury?
Thus, under the new classification rules, some of the devices previously assigned to Class I, now will be Class IIa or Class IIb. In order to assist in the interpretation of the new rules, the document provides examples of the devices subject to reclassification and highlights specific aspects associated thereto.
The scope of the guidance covers, inter alia, the aspects related to the classification rules for devices pre-filled with medicines or biologicals. In accordance with the existing regulatory requirements, the products will not be subject to regulation as a medical devices in case it 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 (may be multi-dose). It is clearly stated in the guidance that such products are falling outside the scope of the Therapeutic Goods (Medical Devices) Regulations 2002, and are not required to comply with the provisions thereof. As explained by the TGA, examples of such products include, inter alia, certain pressurised metered dose inhalers and multi-dose dry powder inhalers refilled with the medications.
Hence, there are no changes to the regulatory status or applicable classification rules for such devices – they are still not considered medical devices.
Actions to be Taken
The document further outlines specific actions to be taken by medical device manufacturers in order to be allowed to continue supplying their products under the new classification rules. These actions will depend on the regulatory status of the product at the moment the new rules take effect.
- Should the device in question be already included in the Australian Register of Therapeutic Goods (ARTG), the country’s register of healthcare products allowed for marketing and used, on the date of new rules coming into force, the registration holder will have to notify the authority accordingly, and then apply for inclusion of the medical device in the ARTG under the new classification rules.
- In case an application for inclusion in the ARTG was submitted before the new rules were implemented, the process will be finalised under the old framework, however, a registration holder will have to notify the authority and then submit a new application under the new rules.
- The authority additionally emphasizes that should a registration holder fail to notify the TGA about the existing ARTG entry or registration in process related to a medical device subject to reclassification, such registration will be canceled, so the registration holder will have to cease the supply.
- All new applications for inclusion in the ARTG should be submitted in accordance with the new classification rules.
In summary, the present TGA guidance provides an overview of the new classification rules for certain types of medical devices, namely for the ones intended to administer medicines or biologics. The document also outlines specific rules to be applied in this respect, including the exclusion criteria.
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