Manufacturer Evidence for medical devices including IVD medical devices
A manufacturer's evidence application must be submitted and accepted by the TGA before lodgement of most medical device and in vitro diagnostics (IVDs) product applications.
Manufacturer Evidence refers to a conformity assessment document or Declaration of Conformity that demonstrates the manufacturer has applied appropriate conformity assessment procedures to a kind of medical device. The Manufacturer Evidence is used to support a medical device or IVD medical device in the Australian Register of Therapeutic Goods (ARTG).
A sponsor submits the conformity assessment document or Declaration of Conformity via their TBS portal to obtain a Manufacture Evidence identifier. The sponsor uses this identifier when they apply to include a medical device or IVD medical device in the ARTG.
The accepted Manufacturer Evidence is linked to all applications for any medical device or IVD medical device other than the following applications for inclusion:
- Class I non-sterile, non-measuring
- Class I IVD medical device
- Class I (export only)
- Class I IVD (export only)
Acceptance of Manufacturer Evidence is the first step before applying for a medical device or IVD medical device to be included in the ARTG.
This guidance outlines:
- Types of acceptable Manufacturer Evidence
- How to submit new Manufacturer Evidence
- How to submit a variation to existing Manufacturer Evidence
All records (including correspondence) provided to the TGA about Manufacturer Evidence must be in English or be accompanied by a certified translation into English.
Acceptable Manufacturer Evidence
The following documentation is acceptable Manufacturer Evidence, depending on the class of the device you intend to include in the ARTG:
- A TGA Conformity Assessment Certificate.
- Overseas market authorisation evidence or conformity assessment document relating to the manufacturer’s quality management system from a comparable overseas national regulatory authority
- Declaration of Conformity to clause 7.5 of Schedule 3 of the Regulations for a system or procedure pack.
For guidance and templates regarding the Declaration of Conformity refer to the Declaration of Conformity templates (medical devices) or Declaration of Conformity templates (IVD medical devices) webpage.
How to submit new Manufacturer Evidence
There is no fee associated with a Manufacturer Evidence application.
If you have not previously submitted Manufacturer Evidence for your medical device, or IVD medical device, you will need to follow the steps below to submit a Manufacturer Evidence application.
You must submit your Manufacturer Evidence, and have it accepted by the TGA before you commence your application for inclusion in the ARTG.
If you have previously submitted Manufacturer Evidence that applies to your new application, you will not need to do this process again. Your Manufacturer Evidence will be available to you in your new application form. The previously accepted Manufacturer Evidence must not be expired when selected for a new application.
If you are unsure whether you have previously submitted Manufacturer Evidence, you are able to check what evidence is available in your TBS account under:
- "Your TGA"
- "Medical device evidence"
Open the TGA Business Portal
- Select 'Login to Business Services'
- Type in your username and password
- From the 'Applications' menu, select 'Manufacturer Evidence' under the 'Medical Device' heading. This will take you to the Manufacturer Evidence page.
- 'Sponsor's own reference' is a free text box. Please use any words that will help you identify the specific documentation you are submitting for your own purposes.
- Select your manufacturer through the "Search" button.
- If your manufacturer does not appear under "Search", please select "New Manufacturer".
- Selecting "New Manufacturer" will open a sub-form where you can enter the manufacturer's details and attach documentation to confirm the details you have entered.
- Once you have entered your information and clicked "Send", you will need to wait for the TGA to process your information before continuing your Manufacturer Evidence application.
- You will receive email notifications from the TBS system upon submission of your information and completion of the process.
- Acceptance of the new information may take 24-48 hours.
- Once you have selected the manufacturer, please complete all remaining fields including selecting "Type of product"
Be careful to select the correct source of certification when completing your application.
Some organisations have extremely similar names that are only discerned by a number. For example, BSI 0086 and BSI 2797 are two different entities for the purposes of this application form. Entering the incorrect BSI entity may result in your application being unsuccessful.
The name and address of the manufacturer should be consistent with the details in the conformity assessment document. If the details are incorrect or inconsistent, you can request TBS to update the client details by sending an email to firstname.lastname@example.org
- Attach supporting documentation.
Only one piece of evidence should be attached to your application. If the evidence is in a language other than English, it should be accompanied by a certified translation into English.
If the information in your application does not match the information in the attached evidence or if multiple documents are attached, your application will be unsuccessful.
Note: an ISO 13845 certificate supports IVD medical devices ONLY and is not acceptable evidence for a non-IVD medical device.
- Select 'Validate'. This will only check that all fields are completed, and that documentation is attached. It will not validate that the information is correct.
- If validation is successful 'Validation successful' will appear at the top of the application together with a unique Evidence Identifier number
- If you have missed an entry the validation will be unsuccessful, and the system will provide you with a message relating to any missing information (e.g., you have not attached documents). You will need to provide the missing information before you can proceed.
- Once you have successfully validated your application you will then need to select 'Submit'
- The Manufacturer Evidence will be submitted electronically to the TGA.
- To view your lodged Manufacturer Evidence, click on 'View lodged submissions.'
Review of Manufacturer Evidence application
Your Manufacturer Evidence will be reviewed, and you will receive a notification with one of the following outcomes:
TGA aims to process Manufacturer Evidence applications within a target timeframe of 15 working days.
Accepted Manufacturer Evidence applications
You will receive an automated email in your inbox in TBS advising that your Manufacturer Evidence has been accepted.
You can view your accepted Manufacturer Evidence in TBS by selecting 'Your TGA information' from the menu on the left in your portal, and then selecting 'Medical Device Evidence'.
The Manufacturer Evidence identifier number is unique to your evidence and is required to complete an application for inclusion.
Manufacturer Evidence will only appear in the TBS inclusion application form after it has been accepted by the TGA. This may not be immediately visible and may take 24 hours to update in the system.
For this reason, it is imperative that you do not start your application for inclusion in TBS until you receive notification that we have accepted your Manufacturer Evidence.
Unsuccessful Manufacturer Evidence applications
You will receive email notification outlining the reasons why the Manufacture Evidence application was unsuccessful.
You should ensure any deficiencies outlined in the email notification are rectified before you submit a new Manufacturer Evidence application or a variation application to an existing accepted Manufacturer Evidence.
Variation to existing Manufacturer Evidence
Further information and guidance are available for sponsors undergoing transition due to EUMDR.
In the following situations, sponsors will need to submit a variation to Manufacturer Evidence:
- You intend to update the Manufacturer Evidence to support a new device application
- You intend to apply to change an existing ARTG entry (a Device Change Request or a Variation) and the conformity assessment document on file is outdated or inappropriate
- There are changes to the manufacturer name or address (where the manufacturer remains as the same legal entity, and the quality management system remains the same, with conformity assessment documents available as evidence).
- When the TGA asks you to provide current Manufacturer Evidence to support existing ARTG entries.
How to submit a variation to Manufacturer Evidence
Open the TGA Business Portal
- Select 'Login to Business Services'
- Click on "Medical Device Evidence"
- Find and open the appropriate accepted Manufacturer Evidence
- Click on 'Create Variation' button – an information message will be displayed “Please wait while the variation is being created” – click OK. Another information message will be displayed –
“A variation document has been created – refer to the view drafts from the eBS portal”.
- Click OK. If the message – “A variation or replacement of this document already exists – a variation has not been created” – click OK.
- “Close” the accepted Manufacturer Evidence view.
This will create draft evidence that will enable you to edit the form.
- Click on “Home”
- Open the “Portal” and click on “View Drafts”
- Find and select the new draft variation of evidence created above
- Select 'Edit' button to edit the form
- Make your amendments
- If you are attaching a replacement document and the scope of the new document has changed, you must indicate that the scope has changed
- You will need to attach relevant electronic supporting documentation to proceed (valid conformity assessment document and letter from the manufacturer or notified body about the change of name or address)
- Click on 'validate'. If validation is successful – a comment “validation successful” indicator will appear at the top of the application.
If you missed an entry, the system will not validate and will provide you with a message relating to any missed information - e.g. – you have not attached any documents.
- Click on “Submit” and the Manufacturer Evidence variation will be submitted to the TGA for review.
The form has been amended to enable sponsors to edit certain fields within the Manufacturer Evidence form, including changing the source of certificate (e.g. Changing from an EC certificate to an Auditing Organisation for MDSAP certificate).
Change to manufacturer's name or address - Documentation required
If the manufacturer name or address has changed, supporting evidence from the notified body or the manufacturer is required. Evidence should document the history and reason for the change and include confirmation (if appropriate) that the manufacturing quality management system and control over the design and production has not changed. If the change in address is due to the addition of a new site, further documentation from the certification body or the manufacturer may be required to verify that the legal entity remains the same.
ARTG entries that are linked to the accepted Manufacturer Evidence variation may not automatically be updated to reflect the change to the manufacturer's name or address.
Once your variation to Manufacturer Evidence has been accepted you will receive an automated acceptance. Please review the ARTG entries to determine if the accepted changes appear appropriately.
If you are unable to see the changes then you may need to submit a Device Change Request (DCR) application to request for your ARTG entries to be updated.
Common reasons for unsuccessful Manufacturer Evidence applications
- The provided evidence is not an acceptable conformity assessment document relating to the manufacturer’s quality management system. For example, an ISO 13485 certificate is not an acceptable Manufacturer Evidence for non-IVD medical devices.
- The information in your application does not match the information in the attached evidence.
- The evidence is presented in a language other than English, and no certified translation to English is provided.
- Multiple pieces of evidence or irrelevant documents were submitted. Note: You can only submit one piece of Manufacturer Evidence at a time, and only the latest version of Manufacturer Evidence is valid.
- For MDSAP certificates, the certificate does not demonstrate that the manufacturer has been assessed and found to comply with the relevant aspects of the Therapeutic Goods (Medical Devices) Regulations 2002.
- The provided evidence is incomplete. For example, not all pages have been provided or a schedule or attachment is missing.
- The certificate is not valid. For example, the certificate has expired, contains redacted or altered information, or the QR code on the certificate does not return a valid certificate.
- There were changes to the manufacturer’s name or address, and there were no supporting documents to substantiate the changes.
- The manufacturer’s quality management system has changed or the legal manufacturer has changed.
|Version||Description of change||Author||Effective date|
|V1.0||Original publication||Medical Devices Branch||October 2019|
|V1.1||Revised, to align with IT changes and changes for European MDR and IVDR transition||Medical Devices Authorisation Branch||November 2022|