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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
Changes to the application process for Class 1 IVD medical devices are underway. The manufacturer's Declaration of Conformity will soon be required at the time of application.
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)
From 1 October, the TGA has made changes to the ARTG inclusion process for non-measuring, non-sterile Class I medical devices . These changes have been incorporated into the guidance in this document.
A Manufacturer Evidence application is not required for Class I
non-sterile, non-measuring and Class 1 IVD medical devices. However, for Class I non-sterile, non-measuring devices, you must submit the manufacturer's Declaration of Conformity with your application for inclusion in the ARTG.
The TGA may also 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:
- Manufacturer's Declaration of Conformity (if your application relates to a Class 1 IVD medical device)
- 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 firstname.lastname@example.org.
- 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 device applications you are required to attach the manufacturers Declaration of Conformity .
- Review the Applicant's Certification. In electronically submitting the application you are declaring, under section 41FD of the Therapeutic Goods Act 1989 (the Act), that 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 your responsibility to ensure that you have correctly classified your device.
- If validation is successful 'validation successful' will appear at the top of the application.
- If you have missed an entry, or have not attached a manufacturer's Declaration of Conformity (if your application is for a Class I non-sterile, non-measuring device), 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, the TGA will assess whether your Class I non-sterile, non-measuring medical device application / Class 1 IVD medical device application meets the requirements to include the device in the ARTG.
If further information is required to determine if your device meets these requirements, or if the kind of device is of concern to the TGA, the TGA may select your application for non-mandatory audit. The TGA may select an applications for non-mandatory audit if the information you provide in or with your application suggests:
- The product is excluded from the requirement to include it in the ARTG1 ; or
- Any of the Certifications you made in your application under section 41FD of the Act appear to be incorrect, for example2 :
- The device is not a medical device;
- The device is incorrectly classified;
- The device does not comply with the Essential Principles;
- The device has not had the Conformity Assessment Procedures applied to it;
- The information provided in or with the application is not complete or correct.
It may take up to four (4) business days to review your application and either include it in the ARTG or select it for audit.
The TGA will advise you, via TBS, whether your device has been included in the ARTG.
Class I medical devices included in the ARTG may also be selected for post market review, to determine the correctness of the entry.
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.
- Section 7AA of the Therapeutic Goods Act 1989 (the Act) allows the Secretary to declare that certain goods are excluded from the requirement to be in the ARTG.
- The complete list of the certifications you must make are set out in the application form, and in s 41FD of the Act.