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Manufacturer Evidence for medical devices

Medical device and in vitro diagnostic (IVD) applications require a manufacturer's evidence application.

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Manufacturer Evidence refers to an issued conformity assessment document relating to the manufacturer’s quality management system, or a Declaration of Conformity (system or procedure pack). They prove the manufacturer has applied appropriate conformity assessment procedures.

The Manufacturer Evidence supports inclusion in the Australian Register of Therapeutic Goods (ARTG). Without this evidence, your device cannot be included on the ARTG.

Manufacturer Evidence identifier

To obtain a Manufacture Evidence identifier, the Sponsor is required to submit the conformity assessment documents through the TGA Business Services (TBS) portal. TBS will action and provide the identifier back to the sponsor. Instructions for submitting a new or variation to existing Manufacturer Evidence application are provided further in the guidance.

To include a medical device or IVD medical device on the ARTG, you need this identifier.

It's linked to all medical device or IVD medical device applications except these:

  • Class I non-sterile, non-measuring
  • Class I IVD medical device
  • Class I (export only)
  • Class I IVD (export only).

Acceptable evidence

There is no fee associated with a Manufacturer Evidence application.

Acceptable Manufacturer Evidence (depending on the class of the device) documents include:

Submit evidence

New applicants

You will need a TGA Business Portal account. if you do not have one apply for access.

  • TGA Business Portal

    Open TGA Business Portal

    Select 'Login to Business Services'

    Type in your username and password

  • Manufacturers Evidence

    Navigate to the 'Applications' menu

    Select 'Manufacturer Evidence'

  • Submitting your evidence

    'Sponsor's own reference' is a free text box. For your own use, use any words that would help you identify the documents.

    Select your manufacturer through the "search" button.

Next steps
You will get an email notification that the submission has come through to us. Acceptance of the new information may take 24-48 hours.

Previous applicants

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. 

Check your TBS account to see if you've submitted Manufacturer Evidence before:

  • "Your TGA"
  • "Medical device evidence"

If there is no entry, follow the steps above for new applicants.

Review of application

After review, you will receive a notification with one of the following outcomes:

  • Accepted
  • Unsuccessful

We aim to process these applications within a target timeframe of 15 working days.

Accepted

You will receive an automated email in your TBS inbox that your Evidence has been accepted.

View your accepted Manufacturer Evidence in TBS by selecting 'Your TGA information'. You will find this in the menu on the left in your portal, and then selecting 'Medical Device Evidence'.

The Manufacturer Evidence identifier number is unique to your evidence. You will need it to complete an application for inclusion.

It won't appear in the TBS inclusion application form until it's approved. This may not be immediately visible and may take 24 hours to update in the system.

Don't start your application until you get a notification your evidence is accepted.

Unsuccessful

If unsuccessful, you'll receive an email outlining the reasons.

Before resubmitting, make sure you fix any defects outlined in the email notification.

Variation to existing Manufacturer Evidence

Manufacturer Evidence will need a variation in the following situations:

  • 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 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 asked for Manufacturer Evidence for existing ARTG entries.

Name or address changes

You will need proof from the notified body or the manufacturer for a change of name or address. 

Evidence should document the history and reason for the change. Confirm that the manufacturing quality management system and control over design and production haven't 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 accepted, you'll get an automated acceptance.

Review the ARTG entries to determine if the accepted changes are correct.

If you are unable to see the changes, submit a Device Change Request (DCR) application.

Variation

Variation - process diagram

  • TGA Business Portal

    Open TGA Business Portal

    Select 'Login to Business Services'

    Type in your username and password

  • Manufacturer Evidence

    Navigate to and click 'Medical Device Evidence'

    Find and open the appropriate accepted Manufacturer Evidence.

  • Variation

    Click on 'Create Variation'

    Several information messages will appear, click 'OK'.

    This will create draft evidence that will enable you to edit the form.

  • Making edits

    Click "home"

    Open the "portal" and click "View Drafts"

    Find and select the new draft variation of evidence created above

    Select 'Edit'

    Make your amendments

    Click 'validate'

    If successful a comment "validation successful" indicator will appear.

If you missed an entry, the system won't validate. You will get a message telling you of any missed information - e.g. - you have not attached any documents.

Submit
Click “Submit”. The Manufacturer Evidence variation will come to us for review.

Common reasons for unsuccessful applications

  1. The evidence is not an acceptable conformity assessment document. For example, an ISO 13485 certificate is not an acceptable Manufacturer Evidence for non-IVD medical devices.
  2. There's a discrepancy between your applications and the evidence attached.
  3. Evidence is in a language other than English, and there's no certified translation.
  4. The evidence was multiple or irrelevant. You can only submit one piece of Manufacturer Evidence at a time. Only the latest version of Manufacturer Evidence is valid.
  5. 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.
  6. The provided evidence is incomplete. There aren't all the pages, or there's no schedule or attachment.
  7. 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.
  8. There were changes to the manufacturer's name or address, but no supporting documents
  9. The manufacturer's quality management system or the legal manufacturer has changed.

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