The Therapeutic Goods Administration (TGA), Australia’s regulating authority in the sphere of healthcare products, has published a final document describing the refinements to the personalized medical devices framework. The new regulatory approach announced by the authority is based on the suggested changes published earlier by the TGA in the course of public consultations conducted by the authority earlier in July 2021.
In the course of this consultation, the TGA collected feedback and suggestions from medical device manufacturers and other parties involved in operations with medical devices that were taken into account when developing this final policy. As a result, the authority decided to implement the following key changes:
- Exclusion of specified products;
- Declaration of some products to be medical devices.
Thus, the amendments impacted the scope of products subject to regulation under the medical devices’ framework.
Exclusion of Specified Products
The first part of amendments introduced by the TGA excludes certain products previously regulated as medical devices from the scope of regulation under the applicable legislation. First, the authority states that during public consultations, it was confirmed that all the parties involved expressed the position that in the majority of cases, medical devices should not be excluded even where the risks associated with them are considered to be very low risk. Hence, the scope of products subject to exclusion was limited to those with the lowest associated risks and low probability of harm caused to the patients’ health or to other persons using the devices.
In particular, under the new framework:
- It was confirmed that additional clarification is needed for the products which are excluded from regulation as medical devices, while in certain cases, the regulatory status for such products remains unclear.
- Accessories to medical devices with such a low associated risk that it makes no sense to apply the requirements that are applicable for medical devices.
- The products that are intended to be used for cosmetic and not medical purposes should be excluded, even if such products formally meet the definition of a medical device.
- Anatomical models that are manufactured using a cast taken from a direct physical impression from a patient’s anatomy are also excluded from being regulated as medical devices.
In particular, the Therapeutic Goods (Excluded Goods) Amendment (Personalized Medical Devices) Determination 2021 provides that certain healthcare products should be excluded from regulation. Such products include the following:
- Cosmetic finishing components for orthoses and prostheses;
- Dental impression trays;
- Medicament trays that are intent ended by the manufacturer to hold medicaments;
- Ocular prostheses intended by the manufacturer to be used for cosmetic purposes;
- Physical impressions of anatomy, and models cast from such impressions.
The authority further describes the impact the changes described above are expected to have. In this regard, the TGA states that the products subject to exclusion will neither have to comply with the regulatory requirements for medical devices nor be subject to supervision by the TGA as the country’s regulating authority in the sphere of medical devices. Consequently, the manufacturing processes and procedures will no longer be subject to TGA’s review and assessment, while the manufacturer will no longer need to apply for marketing approval and inclusion in the Australian Register of Therapeutic Goods (ARTG) in order to be allowed to supply its products to Australian customers. Moreover, the obligation to report adverse events associated with such products would not be applicable as well. At the same time, such products should still comply with the applicable regulatory requirements set forth by other laws and regulations, e.g., consumer protection laws administered by the Australian Competition and Consumer Commission (ACCC) as well as state or territory consumer protection laws.
Hence, should the product fall within the scope of an exclusion described above, its manufacturer is not required to take any additional actions.
Declaration of Some Products to be Medical Devices
Apart from excluding certain products from regulation as medical devices due to the low risks associated thereto, the amendments to the existing regulatory framework also provide that certain products which previously were not subject to the regulation will have to be compliant with the requirements set forth under the medical devices’ framework.
In the course of the above mentioned public consultations on the new regulatory approach, the TGA received the following responses:
- The manufacture of a medical device is a key component of clinical practice in many sectors;
- The approach to risks associated with medical devices applied by healthcare professionals directly involved in manufacturing medical devices differs significantly from the same approach applied by medical device manufacturers;
- A special regulatory regime for custom-made medical devices is vitally important for healthcare professionals to be able to continue producing medical devices.
The authority also states that in some cases, the materials used to manufacture custom-made medical devices are also subject to inclusion in the ARTG. According to the position expressed by the authority, it facilitates the management of risks associated with medical devices in a much more efficient way. Moreover, a similar regulatory approach is applied in many other jurisdictions, including the EU member states. As mentioned by the parties involved in manufacturing custom-made medical devices, the special regulatory pathways applicable for such products make them available for patients without being subject to the unneeded regulatory burden imposed by the general regulatory requirements for medical devices that are not fully relevant in such cases.
According to the Therapeutic Goods (Medical Devices – Specified Articles) Amendment (Personalised Medical Devices) Instrument 2021, there are two categories of products that should be subject to regulation as medical devices, namely:
- Those that fall within the scope of medical devices’ framework, while the regulatory status was unclear; and
- Those that constitute materials or components used in the manufacture of a medical device by a healthcare professional or to the directions/instructions issued by a healthcare professional.
In particular, the products that, according to the amendments, should be subject to regulation as medical devices include the following:
- Materials intended to be used for the restoration of teeth (both direct and indirect);
- Materials intended to be used for manufacturing externally-applied orthopedic devices;
- Materials intended to be used for manufacturing non-implantable dental appliances;
- Materials intended to be used to obtain dental impressions.
Thus, according to the amendments, healthcare professionals engaged in manufacturing certain custom-made medical devices are allowed to waive the requirement to apply for inclusion of their products in the ARTG, as long as the materials used in the manufacturing process are already included in the ARTG.
In summary, the present guidance published by the TGA describes the most important changes to existing Australian medical devices’ regulatory framework with regard to its scope. The document specifies the types of products that should be excluded from regulation or, to the contrary, subject to regulation as medical devices.
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