The new article provides a brief overview of the regulatory status of active medical devices by TGA, the regulatory agency of Australia.
Table of Contents
The Therapeutic Goods Administration (TGA), an Australian regulating authority in the sphere of healthcare products, has published a guidance document dedicated to requests for reconsideration of an initial decision. The document describes in detail the approach to be applied by the parties affected when requesting a regulatory decision be reviewed and reconsidered.
The guidance provides an overview of the applicable regulatory requirements, as well as additional clarifications and recommendations to be taken into consideration by medical device manufacturers and other parties involved in order to ensure compliance therewith.
At the same time, provisions of the guidance are non-binding in their legal nature, and they are not intended to introduce new rules or impose new obligations. The authority also reserves the right to make changes thereto, should such changes be reasonably necessary to reflect corresponding amendments to the underlying legislation.
Regulatory Background
First of all, the document explains the concept of an active medical device as a category of products described in the guidance. Under the general rule, this category applies to products utilizing energy to operate when used for their intended purpose. In particular, as set forth by the Therapeutic Goods (Medical Devices) Regulations 2002, an active medical device:
- Means a medical device that is intended by the manufacturer
- To depend for its operation on a source of electrical energy or other source of energy (other than a source of energy generated directly by a human being or gravity); and
- To act by conveying this energy; but
- Does not include a medical device that is intended by the manufacturer to transmit energy, a substance, or any other element, between an active medical device and a human being without any significant change in the energy, substance, or other element being transmitted.
The authority additionally emphasizes that the software that is a medical device should also be considered an active medical device.
Depending on the design, active medical devices could utilize internal or external power sources.
Exclusions
In order to assist medical device manufacturers and other parties involved in proper interpretation of the above definition, the document also describes cases when products using energy are falling outside the scope of an active medical device definition.
In particular, this applies to products utilizing gravity or enacted by a person. Examples of such products include, inter alia, gravity-fed intravenous infusion sets, non-powered traction systems, hand-operated bag/valve/mask respirators/resuscitators; and hand-powered drills.
As it was mentioned before, the scope of the concept of an active medical device also doesn’t cover the products intended to transmit energy, provided there is no significant change occurring in the course of such a transmission. Examples of such products include, inter alia, electroencephalograph (EEG) leads (purely passive reduction in electrical signal); and tubing sets (reduction in transferred pressure along the tubing).
Essential Principles
In accordance with the applicable legislation, any and all medical devices should comply with the respective Essential Principles in order to be allowed for marketing and use in Australia.
The said Essential Principles outline the main regulatory requirements in terms of safety, effectiveness, and proper performance the product should meet. The document outlines the scope of Essential Principles applicable to active medical devices and highlights the key points associated thereto.
The document also refers to the respective guidelines dedicated to classification rules for active medical devices.
Administrative Appeals Tribunal
The scope of the guidance also covers aspects related to the Administrative Appeals Tribunal (AAT), which is a Commonwealth administrative body that reviews a wide range of decisions made by Australian Government ministers, departments, agencies, and some other tribunals; the AAT takes a fresh look at a decision and, based on all evidence before the AAT, makes the “best of preferable decision” in the circumstances.
The applicable legislation entitles the affected party to apply to the AAT, requesting a decision taken by the Minister be reviewed and reconsidered, should the affected party be dissatisfied with such a decision. In accordance with the general requirements set forth by the Administrative Appeals Tribunal Act 1975, the appropriate application should be submitted in writing no later than 28 days from the date the notice of reconsideration has been given. However, in certain cases, an extension could be requested.
In order to apply for a review and reconsideration by the AAT, an interested party should complete the appropriate form available on the Tribunal’s website and submit it electronically or via mail. It is important to mention that a special fee could apply for the said submission.
In accordance with the procedure, the Tribunal will notify the Minister about the application for review submitted with respect to the decision taken by the Minister. The latter would then have to provide the reasoning behind the decision taken, as well as any other documents the Tribunal would reasonably need to assess the case within the same timeframe of 28 days from the date the appropriate notice is received from the Tribunal.
The authority additionally emphasizes that after an application for review of a reconsideration decision is made to the AAT, the TGA is unable to vary the reconsideration decision and substitute a new decision, unless the applicant and the Tribunal consent to the making of the alternation. The appropriate procedure for alternations and respective consents is set forth by the regulations governing the operations of the Tribunal.
Once the documentation related to the case is provided by the Minister, the Tribunal would initiate a conference to which all the parties involved would be invited. The purpose of such a conference will be to identify issues in dispute, negotiate a settlement of the case, or, if a settlement is not possible, prepare a matter for hearing. In order to organize and streamline this process, the Tribunal will set forth specific timeframes for the parties involved to provide the evidence they deem necessary to support their positions.
The procedure also provides for a voluntary mediation process to be initiated once the parties involved have agreed on it. At this stage, it will be possible to negotiate the way the case could be resolved, while the Tribunal will assist in finding a mutually acceptable solutions as an independent third party. It is important to mention that, in accordance with the rules of the respective procedure, the Tribunal would neither decide on the merits nor instruct the parties on the actions to be taken but rather advise and assist.
Should the parties fail to reach a mutually acceptable solution in the course of the voluntary mediation procedures described hereabove, the case will be further reviewed in the course of a hearing, during which all the parties involved would present their positions before the Tribunal. As a result, the Tribunal would render its verdict based on the information provided. The decision taken upon hearing, as well as the hearing itself, could be publicly available.
In summary, the present TGA guidance highlights specific aspects related to requests for review and reconsideration of the initial decision. The document describes the applicable timeframes, and also explains the procedure involving the Tribunal.
How Can RegDesk Help?
RegDesk is a holistic Regulatory Information Management System that provides medical device and pharma companies with regulatory intelligence for over 120 markets worldwide. It can help you prepare and publish global applications, manage standards, run change assessments, and obtain real-time alerts on regulatory changes through a centralized platform. Our clients also have access to our network of over 4000 compliance experts worldwide to obtain verification on critical questions. Global expansion has never been this simple.
