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Medical device inclusion process
Steps in the process
Step 4 - Submitting an application in TBS for Class I non-sterile, non-measuring and Class 1 IVD medical devices
The following process is for:
- Class I non-sterile, non-measuring, and
- Class 1 IVD medical devices.
For Class I medical device/IVD medical device Export Only go to Step 5 - Submitting an application in TBS for Class I Medical Device (Export Only) and Class 1 IVD Medical Device (Export Only)
For all other medical devices go to Step 6 - Submitting an application in TBS (for all classes except Class I non-sterile, non-measuring medical device, Class 1 IVD medical device and Class I medical device/Class 1 IVD medical device Export Only)
Although a Manufacturer Evidence application is not required for Class I
non-sterile, non-measuring and Class 1 IVD medical devices, and no documentation is required to be attached to your application, the TGA may contact you at any time after your device has been included in the ARTG to request documentation demonstrating that your product complies with any aspect of the relevant legislation. Documents that may be requested include, but are not limited to:
- Declaration of Conformity
- Product information including labels, packaging, brochures, catalogues, Instructions for Use, etc.
How to submit a medical device application for Class I non-sterile, non-measuring medical device or Class 1 IVD medical device
Open the TBS home page:
- Select 'Login to Business Services'
- Type in your user name and password
- From the 'Applications' menu, select 'Device/OTG Application under the 'Medical Device' heading. This will take you to the Device Application page:
- In the 'Application for:' box, select 'Medical Device - Included' for a medical device or 'Medical Device - IVD' for an IVD medical device
- 'Sponsor's own reference' is a free text box. Please use any words that will help you identify the specific product for your own purposes.
- For 'Class':
- select 'Class I' for medical devices
- for IVD medical devices select 'Class 1'.
Note that the fee for your application appears once you select the classification.
- Please answer the remaining questions using the information provided to you by the manufacturer of the product.
In most cases, if you provide an answer to one of the questions that indicates the medical device should be a different classification, you will not be able to validate your form and proceed with your application. There are some questions that are appropriate for more than one class of device - the onus is on the sponsor to make an application for the correct classification.
- Once you have completed the first page, you will need to select 'Next' to progress.
- Select your manufacturer and GMDN code.
If your GMDN code does not appear in the TGA code tables please email the details to email@example.com.
- Once you have completed the second page and you select 'Next' you will be taken to the 'Applicant's Certification' page. A summary of the information you have entered will be provided.
For Class I non-sterile, non-measuring medical devices and Class 1 IVD medical device applications you are not required to attach or add supporting information.
- Review the Declaration. In electronically submitting the application you are declaring that in relation to the device the information given in the application and the statements in the declaration are current and correct. Please note there are civil and criminal penalties associated with supplying false or misleading information. A false declaration will result in the device entry being removed/cancelled from the ARTG
- Select 'Validate'
Selecting 'Validate' will ensure that all mandatory fields have been completed. Successful validation does not mean that the information entered has been confirmed as correct as some responses may be suitable for more than one classification. It is the sponsor's responsibility to ensure that they have correctly classified their device.
- If validation is successful 'validation successful' will appear at the top of the application.
- If you have missed an entry, the system will not validate and will provide you with a message relating to any missing information (e.g. you have not entered the intended purpose). You will need to complete the missing information before you can proceed.
- Once you have successfully validated your application, you will be able to click 'Submit'
- Select 'OK'
- Your application will be submitted electronically.
- The system will provide confirmation that your application has been submitted.
- To view your lodged application click on 'view lodged submissions'.
- An invoice will be sent in TBS to the individual you have nominated to have a financial role.
- Pay the relevant application fee.
What happens next?
Once your application fee is paid, your Class I non-sterile, non-measuring medical device application / Class 1 IVD medical device application will be automatically processed for inclusion in the ARTG (unless the application is subject to mandatory audit under Regulation 5.3 in the Regulations). Unless selected for audit, information within this application is not reviewed by the TGA prior to the device being included in the ARTG.
The automated TBS system will:
- Accept the application.
- Create an inclusion in the ARTG within 24 hours of submission.
- Send you an email advising you of the inclusion of your device in the ARTG.
Class I medical devices included in the ARTG can be selected for post market review. If your product does not meet the definition of a medical device or if it is classified incorrectly, it may be cancelled from the Register.
Applications for inclusion of Class 1 IVD medical devices that are intended for self-testing or use at the point of care must be selected for audit under Regulation 5.3 of the Regulations.