The Therapeutic Goods Administration (TGA), the Australian regulating authority in the sphere of healthcare products, has published a consultation paper describing proposed changes to the regulation of personalized medical devices. As mentioned in our previous article on the subject, the document describes certain changes in the regulatory status of personalized medical devices as well as the procedures associated thereto.
When preparing the present document, the authority conducted consultations with all the parties involved, including numerous healthcare professionals operating with personalized medical devices on a daily basis in order to identify the possible options for improvement.
Table of Contents
New Approach
According to the consultation paper, the primary purposes of the suggested amendments to the regulatory framework for personalized medical devices are:
– Reducing unnecessary regulatory burden for the parties involved by excluding certain types of products from the scope of regulation (provided that this will not expose patients to additional risks), and eliminating overlaps between existing regulations (addressing the situations when the same products fall within the scope of two regulatory frameworks);
- Ensuring the level of supervision and oversight corresponds to the actual risks associated with the medical device; and
- Ensuring any and all medical devices available in the country comply with the applicable regulatory requirements set forth by the national legislation.
The TGA also states that the following three mechanisms will be applied in the course of implementation:
- Exclusion,
- Exemption,
- Inclusion in the Australian Register of Therapeutic Goods (ARTG) through an alternative conformity assessment procedure.
The document further describes each of the mechanisms in detail.
1. Exclusion. Under the amended framework, certain medical devices will no longer be subject to regulation by the TGA. The scope of such an exclusion could cover either all the cases or some specific ones in terms of use or advertising. For the products subject to exclusion, the requirement for inclusion in the ARTG could be waived. These products also would not be subject to assessment or further safety monitoring to be conducted by the TGA as the country’s regulating authority in the sphere of medical devices. Additionally, the requirements on incident reporting would not be applicable as well. The authority would not be able to initiate corresponding regulatory actions (e.g., issuing safety alerts or initiating a recall). The general regulatory requirements on the advertising of medical devices, including the Therapeutic Goods Advertising Code, would not be applicable for such products as well. When determining whether the particular product could be subject to such an exclusion, the aspects to be considered should include the likelihood of harm caused by the product in question, the applicability of national regulations, and the risks associated with the product by other regulatory frameworks. The authority additionally emphasizes that excluded products are still subject to other regulatory requirements, including relevant consumer laws.
2. Exemption. In case of a product subject to an exemption, the responsible party is not obliged to apply for inclusion of the product in the ARTG. However, such a product still should comply with any and all applicable regulatory requirements for medical devices, including the Essential Principles[2] and those related to record-keeping and adverse event reporting. Moreover, the regulating authority reserves all its rights including the right to conduct a post-market review, request additional information reasonably necessary to assess the aspects related to the safety and performance of the medical device in question, suspend the production or marketing of the medical device, issue safety notices and initiate recalls. Additionally, the TGA will conduct oversight with regard to advertising activity and take necessary regulatory actions in case of a failure of a responsible party to comply with the applicable advertising rules and regulations. As in the case of exclusions, an exemption could be applied either for a medical device in general or for some specific use cases (e.g., exemption for a specified product when manufactured by a particular professional or when supplied to a certain type of facility or for a specified purpose).
3. Special conformity assessment procedures for inclusion in the ARTG could be introduced for some of the patient-matched medical devices. According to the consultation paper, this approach could only be applied provided there are sufficient alternative oversight mechanisms ensuring the efficient mitigation of risks associated with a medical device. Thus, the medical device manufacturer will not be required to obtain a quality management system certificate before submitting an application for the inclusion of the medical device in question in the national register.
Main Principles
The document published by the TGA also describes the principles to be applied in the context of suggested amendments to the regulation of personalized medical devices. According to the consultation paper, a risk-based approach should be applied when determining how medical devices should be treated. In particular, the main factors to be taken into consideration include the duration of use of a medical device and the level of invasiveness.
The TGA further describes the particular principles to be applied when implementing each of the mechanisms described above.
- Exclusion from regulation could be applied for products that fall outside the scope of the definition of a medical device, meeting the definition of a low-risk accessory, or that meet the aforementioned definition but are mostly used for non-medical purposes, and such use does not expose patients to additional risks.
- Exemption from inclusion in the national register could be applied in case of medical devices defined as Class I non-sterile patient-matched medical devices without measuring functions provided there are alternative oversight mechanisms in place which are sufficient to ensure the safety and effectiveness of such devices,
- Alternative conformity assessment procedure could be applied for Class IIa patient-matched medical devices provided that there are alternative mechanisms of oversight for the manufacture and an alternative use of the device, and the manufacturer undertakes a self-assessment and declaration that they meet the regulatory requirements.
According to the TGA consultation paper, the scope of the products that could potentially be excluded from regulation in accordance with the principles described above covers anatomical models manufactured for educational purposes, orthodontic appliance positioning tray, mouthguard for sports purposes, and some other products. The products subject to such exclusion would no longer need to comply with the regulatory requirements for medical devices, including compliance with the Essential Principles, as well as the requirements on reporting and advertising. However, all products should still comply with the provisions of the general consumer protection regulations applicable in the country.
The TGA further states that certain Class I patient-matched medical devices could be exempted from inclusion in the ARTG, which currently is mandatory for any and all medical devices, provided that:
- The device is manufactured by a trained, accredited professional; or
- Other third-party mechanisms of oversight are in place that are suitable to manage the low risk that may be posed by the device.
In summary, the present TGA consultation paper describes the suggested regulatory approach for personalized medical devices. The document outlines the main principles to be applied when determining where the device could be subject to exclusion, exemption, or an alternative conformity assessment procedure.
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