The Therapeutic Goods Administration (TGA), the Australian regulating authority responsible for medical devices, announced the reduction of annual charges for medical devices listed on the prostheses list.
Prostheses Medical Devices: Regulatory Background
According to the official information published by the TGA, a prosthesis is an artificial substitute or replacement body part attached or applied to the body to replace a missing part. The regulation provides that the prosthesis device should be included in the Prostheses List. The examples of such medical devices include, inter alia:
- heart valves,
- cardiac stents,
- cardiac implantable electronic devices, such as pacemakers and defibrillators.
In accordance with the applicable rules, external breast prostheses and other devices used only for cosmetic purposes are not eligible to be listed in the Prostheses List.
Current regulation related to the aforementioned devices is based on the Private Health Insurance (Prostheses) Rules (No. 2) 2020. These Rules were adopted on June 17, 2020, and entered into effect on July 1, 2020. The Prostheses List mentioned herein actually constitutes an annex to the Private Health Insurance (Prostheses) Rules.
The scope of application of these rules covers surgically implanted prostheses, as well as human tissue items.
Annual Charges for Prostheses List Devices
The TGA acknowledges certain difficulties faced by the healthcare industry due to the outbreak of the Coronavirus Disease 2019 (COVID-19) caused by the virus “SARS-CoV-2” or the “novel coronavirus”. In order to assist industry representatives, the Australian Government announced that annual charges apply for certain types of medical devices would be reduced. In particular, a 50 percent reduction would be applied to medical devices listed on the prostheses list, providing that such devices are included in the Australian Register of Therapeutic Goods (ARTG) – the national register of medicines and medical devices.
According to the information published by the TGA, the following fees should be applied:
- for Active Implantable Medical Devices (AIMD) – USD 600;
- for Class IIa medical devices – USD 470;
- for Class IIb medical devices – USD 470;
- for Class III medical devices – USD 600.
At the same time, for other types of medical devices, the annual fees remain unchanged, namely:
- for non-sterile Class I medical devices without a measuring function – USD 90;
- for sterile Class I medical devices, or ones having a measuring function – USD 630;
- for Class IV in-house in vitro diagnostic medical devices – n/a.
- for all other in vitro diagnostic medical devices – USD 680.
When considering the eligibility of the particular device to the aforementioned annual charge reduction, the authority will consider the Prostheses List (PL) dated April 8, 2020. In particular, the ARTG inclusion number would be used to identify the eligible devices. The TGA also recommends all interested parties to check whether the ARTG inclusion number is correct and inform the agency accordingly if any correction needed.
The annual charge reduction should be also applied for the whole ARTG entry that includes several medical devices providing that at least one of such devices is included in the Prosthesis List.
All parties involved will receive new invoices in August, and such invoices would already include the amended annual charges. However, it is important to mention that the reduced annual charges are applicable only for the 2020-21 financial year.
According to the appropriate TGA guidelines, no actions need to be performed by any party intending to apply for charge reduction since it would be implemented automatically by the authority in the way and under the conditions described hereabove. This depends on the ARTG inclusion code assigned to the particular medical device in question.
Australian Therapeutic Goods (Charges) Regulations
When describing the regulations in the sphere of charges related to medical devices, it is important to mention that the main legislative act governing the appropriate relationships is the Therapeutic Goods (Charges) Regulations 2018 based on the Therapeutic Goods (Charges) Act 1989. The current version of the document was adopted on July 1, 2019. The scope of the document covers medical devices, as well as medicines and registered therapeutic goods. Besides medical devices, the scope of the Regulation covers biologic defined as therapeutic goods in which the active ingredient is a substance of biological origin. The document is also applicable to all devices classified as medical devices under the Therapeutic Goods (Medical Devices) Regulations 2002.
In the part of medical devices, the Therapeutic Goods (Charges) Regulation provides charges related to:
- the inclusion of medical devices in the ARTG,
- annual establishment licenses for medical device manufacturers.
The amount to be paid by the medical device manufacturer depends on its operating activity and the particular type of medical devices produced. According to the document, a charge for a license covering the manufacturing of sterile or non-sterile medical devices is USD 6,150. The aforementioned payment should be applied for every single type of device. The TGA also states that in the case of several different charges are applicable, the highest one should be paid.
Summarizing the information provided hereabove, the TGA introduces the reduced annual charges payable by the parties involved in operations with medical devices in order to reduce the burden during the COVID-19 outbreak that causes a significant impact on the whole industry. In particular, the authority implements a 50 percent reduction for certain classes of medical devices, including ones assigned to Class IIa, IIb, and III. These measures are intended to ensure and expand the availability of medical devices during the pandemic to avoid potential shortages of vitally important medical devices. At the same time, the scope of the annual charge reduction covers only those medical devices included in the Prostheses List – an annex to the Private Health Insurance (Prostheses) Rules that includes medical devices intended to be implanted to replace particular body parts. However, the document also covers all the devices of the particular ARTG entry providing that at least one of the devices is subject to regulation.
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