The Therapeutic Goods Administration (TGA), the Australian regulating authority in the sphere of healthcare products, has published a consultation paper dedicated to the proposed refinements to the regulation of personalized medical devices.
According to the official notice, the new framework was implemented earlier in February 2021. The new approach provides a transitional period until November 2024 to allow medical device manufacturers and other parties involved to achieve compliance with the new regulatory requirements. However, in the course of the actual implementation of the new framework, numerous issues have been identified.
Additionally, numerous concerns have been raised by industry representatives complaining that:
- The new framework actually duplicates regulation that already exists,
- The classification for certain medical devices are unjustified and do not correspond to the risks associated with such devices,
- The additional regulatory burden the parties involved are facing in order to comply with the new regulatory requirements is unjustified as well.
In order to address the issues listed above, the TGA proposed certain amendments to the new regulatory framework for medical devices. The purpose of the present consultation is to commence public discussions on the matter and collect feedback and suggestions from industry representatives and other parties involved in order to improve the new regulatory approach. In particular, the authority intends to establish an optimal balance between ensuring the safety of patients with regard to the risks associated with the medical devices in question and avoiding unnecessary regulatory burden.
As mentioned, the amendments to the Therapeutic Goods (Medical Devices) Regulations 2002 were adopted earlier in February 2021. The scope of these changes covers personalized medical devices defined as those designed and manufactured for individual patients. The new regulatory approach introduces new definitions for the terms used in the context of personalized devices and also amends certain regulatory requirements.
According to the current legislation, any and all medical devices intended to be marketed and used in Australia should be included in the Australian Register of Therapeutic Goods (ARTG), the country’s register of healthcare products, unless such devices fall within the scope of one of the exemptions. Such an exemption applies, for instance, for custom-made medical devices.
The main concept used in the context of medical devices is the intended purpose, which should be determined by its manufacturer and indicated in all documents accompanying the product, including the instructions for use, labeling, or any materials used to promote the device. The intended purpose of the device should also be taken into consideration when determining the classification of a medical device under the applicable risk-based classification. Consequently, it should also be considered when determining the scope of conformity assessment procedures to be performed before placing a medical device on the market in order to assess its safety and effectiveness.
It is stated that the medical device manufacturer shall follow the conformity assessment procedures required based on the class of the medical device under the risk-based classification in order to demonstrate all essential principles of safety and performance are met. The authority additionally emphasizes that the manufacturer is entitled to determine the particular approach to be applied to demonstrate such compliance, which provides additional flexibility.
The regulatory burden will depend on the classification of the medical device and its intended purpose. However, irrespective of the classification of the medical device, any and all manufacturers shall:
- Meet the conformity assessment certification requirements appropriate to the level of classification of the device being manufactured; and
- Have evidence that demonstrates compliance of their medical devices with the relevant essential principles.
In the case of non-sterile Class I medical devices, the applicable procedures will be simplified due to the relatively low risks associated with such devices. In particular, such devices could be included in the ARTG under the notification (self-certification) procedure with no additional assessment to be performed by the regulating authority. For all other medical devices, the appropriate certification from an independent body is required. As an alternative approach, the medical device manufacturer may apply for a certification to the TGA before applying for inclusion in the ARTG.
Special Rules for Personalized Medical Devices
Before the new framework entered into force, personalized medical devices were covered by the scope of regulation for custom-made products. Hence they were exempt from inclusion in the ARTG, provided they were compliant with the Essential Principles. In particular, the manufacturers had to:
- Ensure that the devices were not creating additional hazards to health and safety,
- Be able to provide evidence demonstrating the safety of the product,
- Comply with the applicable requirements in terms of labeling and packaging,
- Include Instructions for Use with the devices in order to ensure that users have all the information necessary to use them in a safe and efficient way.
Additionally, medical device manufacturers were obliged to report adverse events arising when using the products to the regulating authority.
Under the exemption rule for custom-made medical devices, it was sufficient for the manufacturer to notify the regulating authority about placing a new product on the market within two months.
The authority states that due to the development of technologies in general, custom-made medical devices have become more complicated. The risks associated with some of them have also increased accordingly. This situation has prompted the TGA to review its approach for custom-made devices and improve the existing regulatory framework. When developing the new approach, the TGA conducted several consultations dedicated to regulatory requirements for personalized medical devices. As a result, a new framework was developed. The initial date the new requirements entered into force was February 25, 2021. However, there is a transitional period until November 1, 2024, allowing medical device manufacturers to achieve compliance with the new requirements.
In order to assist medical device manufacturers and other parties involved, the TGA further provides a summary of the changes made to the regulations for personalized medical devices. The most important ones are the following:
- Patient-matched medical devices were separated into a special category. Such devices will be subject to mandatory inclusion in the ARTG.
- The exemption criteria for custom-made medical devices also have been changed.
- Medical devices manufactured by healthcare facilities are also subject to conformity assessment and inclusion in the ARTG.
- Anatomical models were reclassified to Class IIa medical devices.
The authority states that the parties responsible for medical devices falling within the scope of the amendments shall take all necessary steps to ensure the inclusion of these devices in the ARTG prior to November 1, 2024. First, these devices should be subject to the third-party certification required to demonstrate conformity with the applicable essential principles in terms of safety and effectiveness.
In summary, the present TGA consultation paper describes the changes to the regulatory requirements for personalized medical devices. The document highlights the main aspects related to the new framework and clarifies the particular steps to be taken by the medical device manufacturers and other parties involved in order to achieve and sustain compliance with the new regulation.
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