The Therapeutic Goods Administration (TGA), an Australian regulating authority in the sphere of healthcare products, has published a guidance document dedicated to applying for consent to import, supply, or export a medical device that does not comply with the Essential Principles.
The document highlights the most important aspects to be considered when submitting such an application and also provides additional clarifications and recommendations to facilitate the application process. It is important to mention that to improve the regulatory processes and procedures, the authority replaces paper submissions with electronic ones. Such an approach will provide the applicants with additional flexibility, allowing them to have access to not only current applications but also the ones submitted previously. As further explained by the TGA, the change will take place in two steps, and the first one has been already completed, so medical device manufacturers could already use the interim electronic application form described in the present guidance.
Under the general rule, all medical devices intended to be imported, supplied, or exported should comply with the applicable Essential Principles, while it is strictly prohibited to conduct such activities with non-compliant devices, as this could result in civil penalties and criminal offenses. However, the Secretary of the Department of Health is entitled to grant special consent allowing the interested party to conduct such actions. This consent could be provided in case certain circumstances are making it impossible for the interested party to comply with the applicable regulatory requirements for a limited period.
The authority additionally emphasizes that the aforementioned special consent would be necessary even if there is a current application for inclusion in the Australian Register of Therapeutic Goods (ARTG).
Thun, to obtain such consent, an interested party should complete the following steps:
- Complete and submit the application for “consent to import, supply or export a medical device that does not comply with the Essential Principles”;
- Attach all relevant documentation; and
- Pay the application processing fee in full.
It is also important to mention that it is allowed to include more than one medical device in the application. Such devices could be either already included in the ARTG or the process of inclusion. However, should an interested party decide to include several medical devices in its application for consent, all such devices should be non-compliant with the same Essential Principles, otherwise the applications for such devices should be submitted separately. Moreover, there is a limit of 20 entries within one application, so should the applicant need to apply for more, several applications should be submitted. At the same time, all these forms would be linked together to be considered as parts of one application. For this purpose, a response ID would be used – such an ID would be communicated to the applicant via email once the form has been submitted.
On a side note, the TGA states that in the case of implantable devices with non-compliant patient information materials, an application form could cover more than 20 entries. In such cases, a special form should be used.
Class I Software Medical Devices
Class I is the lowest class under the applicable classification system and applies to the devices with the lowest risk associated thereto. Hence, the applicable regulatory controls are quite low as well. In the case of software-based medical devices, this class applies for the devices that are:
- Intended to monitor the state or progression of a disease;
- Providing information that does not indicate if an individual may be in danger;
- Associated with a low public health risk.
Class IIa Software Medical Devices
This category applies to medical devices associated with medium risk. An example provided by the TGA describes diabetes diagnosis software that is intended to be used by a healthcare professional. Thus, such a product is a Class IIa medical device as the device provides information to a relevant health professional to inform the diagnosis of a serious disease. This category also covers risk prediction software, as well as the tools that record data from a patient monitor or images directly from an MRI scanner (provided that such software does not impact the operations of a scanner itself).
Class IIb Software Medical Devices
This category applies to medical devices associated with medium-high risk. For instance, such classification should be applied to a product that is intended to analyze a cardiac MRI in order to provide information used in making diagnoses of related diseases. As in the previous example, the software is intended to provide information to healthcare professionals only. As described in the guidance, Class IIb applies to medical software that is intended by the manufacturer (the software developer) to provide information to a relevant health professional to inform the diagnosis of a serious disease. Other examples of Class IIb products include tools intended to be used to diagnose an acute arterial occlusion due to the severity of potential consequences of this disease if the necessary treatment is not applied. This category also covers software products that are intended to provide recommendations for treatment or intervention on the basis of input data (e.g., a coronary angiogram). As in the previous cases, such software should be used only by healthcare professionals. Consequently, a Class IIb software-based medical device is the one that is intended to:
- Recommend a treatment or intervention to a relevant health professional for the purposes of making a decision about the treatment or intervention; and
- Be used in cases when the absence of a treatment or a treatment itself could result in severe health deterioration or other adverse consequences.
The same classification applies to wearable devices intended to collect and analyze data for screening for serious heart diseases, as well as questionnaire apps intended to analyze the information provided by a patient and provide a diagnostic output.
As it was mentioned before, an applicant should duly pay the fees for processing the application. These fees should be paid per entry, irrespectively of the number of forms submitted, and constitutes $500 for the first entry, and $100 for each subsequent entry. Hence, to calculate the processing fees payable, an applicant should multiply the number of entry entries covered by the forms submitted by the amounts provided hereinabove. The authority additionally emphasizes that in case of several forms submitted, all the forms intended to be submitted within the scope of a single application should be submitted within 24 hours, otherwise they would be treated as a separate submission, and a basis $500 for the first entry will be applied.
In the case of implantable medical devices with non-compliant patient information, a special approach should be applied about fees as well: in particular, there is a special fee of $300 per entry. These changes in applicable fees have been introduced in October 2021, so the authority also mentions that there is a refund option for the applications submitted earlier, but after January 1, 2021. To get a refund, an interested entity should submit an appropriate refund request to the TGA (Product Billing and Industry Assistance team).
There are two options of how the processing fees described hereinabove could be paid:
- Immediate payment (via the TGA payment page using the ARTG/Application for Inclusion number). It is important to mention that in such a case the fees should be paid upon submission of a final form, otherwise all subsequent forms would be treated as separate applications, and the initial fee would apply.
- Payment against invoice. An applicant could also request the appropriate invoice to be issued by the TGA.
Irrespective of the option used by the applicant, the TGA will not process the application for consent, until the processing fees are fully paid.
Application Form: Key Points
The guidance further describes the new application form to be filled in electronically by the entity seeking consent for import, supply, or export of medical devices that are not compliant with the Essential Principles. The authority also mentions that the information provided by the applicant would not be publicly available.
The whole navigation is based on the Contest page which links together all elements of the form to be filled in by the applicant. Once one of them has been completed, an applicant will be redirected back to the Contest page to be able to proceed with the next element.
According to the screenshot of the Contest page provided by the TGA, the application for consent to import, supply, or export non-compliant medical devices is comprised of the following elements:
- Applicant Details,
- Information on non-compliance to the Essential Principles,
- ARTG/Application for Inclusion – 1,
- ARTG/Application for Inclusion – 2.
The first three elements are mandatory, and the application would not be processed until they will be completed, while the last one should be used in case the applicant decided to include several entries within the same application.
In summary, the present TGA guidance provides an overview of a new procedure to be followed when applying for consent to import, supply, or export a medical device that is currently not compliant with the applicable Essential Principles. The document describes the way the application should be submitted and also outlines the most important aspects to be considered, including the submission process and applicable processing fees.
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