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Devices

Getting approval for your medical device, IVD, disinfectant or tampon

There are several different systems regulating the different types of medical devices used in the healthcare sector.

We can help you identify which devices are ‘medical devices’, which are ‘therapeutic devices’ and which are ‘in-vitro diagnostics’ (IVDs). We know the requirements for each category and we can help you ensure that you have the correct documentation to support approval in Australia.

We can review your documents and assist you if you want to do it yourself, or we can prepare and submit the documentation for you.

Find out more about:

Medical Devices

Getting approval for your medical device

All medical devices supplied in Australia are required to be included in the ARTG prior to supply unless they are exempt or excluded.  Medical devices have a huge range and can be anything from a bandage to a heart pace maker.

At Archer Emery & Associates, we can help you by:

  • Providing ad hoc advice verbally and/or in writing on any regulatory issues related to existing or proposed medical devices
  • Determining if an application is required and, if so, determining the application category and data requirements
  • Reviewing manufacturer certifications for acceptability to the TGA
  • Reviewing technical files for compliance with TGA requirements
  • Advising on gaps and ways to fill them
  • Assisting with product development as needed
  • Reviewing labels and Instructions for Use for compliance with TGA requirements
  • Preparing product applications and Declarations of Conformity
  • Preparing dossiers if required
  • Preparing Clinical Evaluation Reports in the TGA’s preferred format. These are complex documents that usually include a literature review and assessment. 
  • Assisting in the preparation of risk documentation in accordance with ISO 14971
  • Submitting applications and liaising with the TGA and you throughout the assessment process

IVDs

Getting approval for your IVD

IVDs are a subset of medical devices that have some different regulatory processes.  There are many types of IVDs and some examples are pregnancy tests, Covid-19 tests, diagnostic tests for infection or disease, diagnostic equipment and specimen receptacles.

At Archer Emery & Associates, we can help you by:

  • Providing ad hoc advice verbally and/or in writing on any regulatory issues related to existing or proposed IVDs
  • Determining if an application is required and, if so, determining the application category and data requirements
  • Reviewing manufacturer certifications for acceptability to the TGA
  • Reviewing technical files for compliance with TGA requirements inlcuding verification and validation of performance and assessment of clinical utility
  • Advising on gaps and ways to fill them
  • Assisting with product development as needed
  • Reviewing labels and Instructions for Use for compliance with TGA requirements
  • Preparing product applications and Declarations of Conformity
  • Preparing Summary Technical Documentation (STeD) dossier if required
  • Preparing Clinical Evaluation Reports in the TGA required format.
  • Assisting in the preparation of risk documentation in accordance with ISO 14971
  • Submittingapplications and liaising with the TGA and you throughout the assessment process

Manufacturer’s evidence

Getting approval to use your manufacturer in medical device applications

Manufacturers of medical devices and IVDs other than Class I products are required to hold either a TGA Conformity Assessment Certificate or an overseas equivalent certification that is acceptable to the TGA and covers the scope of the products to be included in the ARTG.

At Archer Emery & Associates, we can help you by:

  • Reviewing manufacturer certifications for acceptability to the TGA
  • If it is acceptable, preparing manufacturer’s evidence notifications and submitting them to the TGA

Conformity Assessment Certificates (CAC)

Getting approval for your legal manufacturer

If a manufacturer does not already hold a suitable certification, they need to apply to the TGA for a CAC.  There are various levels of these and the one that is needed depends on the products intended to be supplied under it.  These are often very complex submissions that cover the whole of the quality requirements for the manufacturing process and often the design elements of the products also.

At Archer Emery & Associates, we can help you by:

  • Providing ad hoc advice verbally and/or in writing on any regulatory issues related to existing or proposed CACs
  • Determining if an application is required and, if so, determining the most appropriate application category and data requirements
  • Reviewing technical files for compliance with TGA requirements and ISO 13485
  • Advising on gaps and ways to fill them
  • Preparing the CAC application and the supporting data form
  • Preparing the quality management system (QMS) dossier
  • Preparing Clinical Evaluation Reports in the TGA preferred format if required. These are complex documents that usually include a literature review and assessment.
  • Assisting with the preparation of risk documentation in accordance with ISO 14971
  • Submitting applications and liaising with you and with the TGA and throughout the assessment process.

CAC substantial change requests

Once you have your TGA Conformity Assessment Certificate, you have a responsibility to ensure that it is kept up to date and to notify the TGA of any substantial changes and wait for the TGA’s approval before implementing the change.

Not every change is substantial, and if the TGA does need to be notified, the process can be complex, time consuming and costly.

At Archer Emery & Associates, we can help you by:

  • Reviewing your change to determine whether it is a substantial change or not
  • Liaising with the TGA in cases that are borderline, so your position is protected
  • Assisting with preparing a substantial change request application and supporting documentation
  • Submitting the substantial change application and liaising with the TGA throughout the assessment process

Consent to supply non-compliant devices

Sometimes your device will not be able to comply with the Essential Principles (EPs).  It may be a labelling issue, or something related to the quality of the product. 

In cases like these it is possible that the TGA will grant a consent which will allow you to supply your product even if it does not meet all aspects of the relevant EPs.  This may be for certain batches or for a particular period of time. 

At Archer Emery & Associates, we can help you by:

  • Assessing the issue and determining if there is a non-compliance with an EP
  • Advising you on whether the TGA is likely to grant a consent
  • Advising on the type of information the TGA is likely to want to review in order to decide whether to grant the consent

Assisting you with the consent application and dealing with the TGA as needed

Other Therapeutic Goods (OTGs)

Getting approval for your hard surface disinfectants and tampons

Other therapeutic goods (OTGs) are hard surface disinfectants (not intended to be used to disinfect a medical device) and tampons.  These product types are regulated differently to other devices. 

At Archer Emery & Associates, we can help you by:

  • Providing ad hoc advice verbally and/or in writing on any regulatory issues related to existing or proposed OTGs
  • Determining if an application is required and, if so, determining the application category and data requirements
  • Review technical files for compliance with TGA requirements including TGO 104
  • Review labels and instructions for use for compliance with TGA’s requirements
  • Advise on gaps and ways to fill them
  • Prepare applications and supporting dossiers
  • Submit applications and liaise with you and with the TGA throughout the assessment process.

Contact Us

Archer Emery and Associates – the Therapeutic Goods Administration (TGA) Experts. To find out how to enhance your regulatory team and maximize your chances of success – whatever the project. Click here to get in touch >>

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Postal Address:
PO BOX 638 Duncraig
WA 6023

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