The Therapeutic Goods Administration (TGA), the Australian regulating authority responsible for medical devices, has published detailed guidelines dedicated to the process of inclusion of a new medical device in the Australian Register of Therapeutic Goods (ARTG), the national register of healthcare products approved for marketing and use in the country. The official information published by the authority provides an overview of the process, describing it step-by-step and highlighting the most important aspects to which an applicant shall pay attention.
According to the current regulatory requirements, inclusion in the ARTG is mandatory for any and all medical devices intended to be placed on the Australian market unless they fall within the scope of specific exemptions or exclusions. This will also be required in order to meet the eligibility criteria for obtaining a Certificate of Free Sale or an Export Certificate.
As stated by the TGA, the requirements for applications for inclusion in the ARTG will differ depending on the class of a medical device in question under the applicable risk-based classification. The information notice further describes the types of applications one should submit to get a product included in the register.
Application for Class I Non-Sterile, Non-Measuring Devices, Including IVDs
The first type of application should be applied in the case of Class 1 medical devices (both general and in vitro diagnostic) that are supplied non-sterile and have no measuring functions. Such devices are deemed to be low-risk products under the applicable risk-based classification. It is important to mention that in the case of medical devices falling within the scope of this category but intended solely to be exported from Australia, another pathway should be applied.
The authority additionally emphasizes that recent changes were made to the regulatory requirements for the inclusion process related to Class I non-sterile, non-measuring devices. The information notice already incorporates the abovementioned amendments to existing legislation.
It is important to mention that a Manufacturer Evidence application is not mandatory for medical devices falling within the scope of this category. At the same time, the appropriate Declaration of Conformity should be submitted by the medical device manufacturer. Moreover, the regulating authority reserves the right to request additional information and documentation reasonably necessary to confirm that the medical device subject to review meets any and all applicable regulatory requirements in terms of safety and performance, even after the device has already been included in the register.
According to the notice, such documentation may include, inter alia, the following elements:
- Manufacturer’s Declaration of Conformity (if the application relates to a Class 1 IVD medical device);
- Product information including labels, packaging, brochures, catalogues, instructions for use (IFU), etc.
The appropriate application should be submitted online via the special portal operated by the TGA. In particular, an applicant shall access the portal using its account credentials and complete the form by answering the questions contained therein. In the course of the application process, an applicant will also have to provide information about the medical device manufacturer and indicate GMDN code. All the information provided when completing the form should be valid and accurate – an applicant will verify this by electronically signing the document. The system will automatically check whether all mandatory fields are filled and proceed with the submission of the application for further review by the authority. An applicant will also receive an invoice for the application review fees. The TGA mentions that the actual review of the application will commence only once the aforementioned invoice is paid by the applicant. The authority is also entitled to select the application for non-mandatory audit. Usually, it takes up to 4 business days for the regulating authority to review the application submitted and decide whether it should be accepted (in such a case, the medical device in question will be included in the register) or selected for an additional audit. The authority will also duly inform the applicant about the decision taken. It is also important to mention that certain medical devices could also be selected for post-market review in order to assess whether the information provided is correct.
Application for Class I Medical Devices Intended for Export Only
The TGA additionally clarifies the procedures to be followed in the case of Class I general and Class 1 in vitro diagnostic medical devices intended to be exported from Australia without being placed on the local market. In the case of such devices, a special online form should be used. The authority additionally emphasizes that an applicant will also have to submit the Declaration of Conformity issued by the medical device manufacturer.
The rest of the procedures are similar to those applied in the case of Class I non-sterile, non-measuring, and Class 1 IVD medical devices described hereabove.
Application for Other Classes
Should the medical device in question fall outside the scope of the abovementioned categories, a special procedure should be applied. In particular, the TGA will expect additional information to be provided with regard to medical devices with moderate and high risks associated thereto. However, the authority states that such information should be in place to be provided upon request but should not be uploaded together with the initial application.
This information shall include:
- All materials associated with the medical device and used to inform customers about its functions and features or to promote it (including IFU, packaging, advertising materials, etc.);
- Description of a mechanism of action – for borderline products – and also the appropriate justification for the determination made by the manufacturer;
- Sufficient evidence demonstrating that the medical device subject to review meets any and all applicable Essential Principles related to safety and performance. In the case of medical devices with high risks associated thereto the appropriate clinical evidence report and/or risk management report could be required.
As in the case of medical devices assigned to other classes, an applicant will have to complete the appropriate online form and answer the questions contained therein. The form used for the devices falling within the scope of this category is wider than for low-risk ones and requires such details as the Unique Product Identifier (UPI), functional description, total number of devices covered and where applicable, variant type and variant range.
In summary, the official guidelines published by the TGA describe in detail the process to be followed for the inclusion of a medical device in the Australian Register of Therapeutic Goods. The information notice provides additional clarifications regarding specific types of applications to be submitted depending on the class of the device under the risk-based classification and also outlines the scope of information to be provided by the applicant in each particular case.
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