Steps to supply for device manufacturers

Steps in the process

Step 1: Determine if your product is a medical device

First, figure out if your product is a medical device.

The is my product a medical device tool can help you work out if your product is a medical device.

Step 2: There must be a sponsor

Australian manufacturers

If you are an Australian manufacturer of a medical device, you are a sponsor. 

You can choose to:

• include devices in the ARTG yourself (go to Step 4)
• supply devices to other sponsors (go to Step 3)

Overseas manufacturers

If you are an overseas manufacturer, you will need an Australian sponsor. You can supply to multiple sponsors. Go to Step 3.

Sponsors cannot use information already provided to the TGA by other sponsors as part of other applications. If you have more than one sponsor, you may need to provide the same information to each one. See Steps to supply for sponsors for more information.

Step 3: The information is accessible

Make a written agreement with your sponsor about requesting and sharing information. We do not provide legal advice about your written agreement with your sponsor. 

The agreement needs to meet the requirements outlined below.

It's up to you and your sponsors to provide certain information in English, when requested. 

We can request information from you at any time:

• during the application process and after your device is being supplied
• about devices currently or previously
  • imported into
  • exported from
  • supplied in Australia.

Step 4: Check if your device is exempt

Most medical devices need to be included in the ARTG before they can be supplied.

In some cases, devices can be supplied without being included in the ARTG if an exemption applies. Some exemptions require notification to, or approval from us. 

For example, devices: 

• supplied for clinical trials in Australia
• prescribed by Authorised Prescribers
• supplied under the Special Access Scheme
• that are custom-made medical devices.

Step 5: Meet the Essential Principles

The Essential Principles are legislative requirements relating to the safety, performance, and quality characteristics of medical devices.

You must always hold scientific, engineering, clinical and other technical documentation that demonstrates that your devices meet the Essential Principles before your devices can be supplied in Australia.

Your sponsors must be able to access this evidence within specific timeframes. Most manufacturers keep their evidence in a ‘technical file’ or a ‘design dossier’.

There are no specific requirements for how you must format or organise your technical documentation. We accept the specific formats required by other regulators, e.g., the IMDRF STED format.

Importing, supplying or exporting a medical device that does not meet the Essential Principles is an offence under the Therapeutic Goods Act 1989.

Step 6: Know the class and category

Determine the class and category of your medical device. 

For these medical devices you will need to submit a manufacturer’s declaration of conformity with the medical device inclusion application:

• Class I non-sterile, non-measuring medical device
• Class 1 IVD medical device
• Class I (export only) medical device
• Class 1 IVD (export only) medical device
• System or procedure packs where the manufacturer uses the special procedure

For all other devices, you need manufacturer evidence before making an application. 

Step 7: Get manufacturer evidence

Decide which manufacturer evidence you will need.

Apart from devices that you can self-certify, you must have one of the following forms:

• comparable overseas regulator evidence
• Conformity Assessment certificate issued by the TGA.

Your evidence must be in line with what is acceptable for the classes of device you intend to manufacture and supply.

If you are a new manufacturer, you may need to put in place a quality management system and organise to be certified by a recognised body.

Step 8: Share manufacturer evidence

Your sponsor will need to submit your manufacturer evidence to us and apply for approval to supply your device in Australia.

We may also ask your sponsor to provide additional information about your device or your manufacturer evidence. 

This could include the: 

• Instructions For Use (IFU) for the device,
• clinical evidence, or
• other technical documentation. 

This could occur if we select the application for an audit.

The sponsor will need to be able to arrange for your technical documentation for the device to be provided to the TGA if requested. 

You will need to arrange with the sponsor how this will happen.

Step 9: Receive the outcome

Once your sponsor has submitted the application, we will conduct a preliminary assessment. 

We will make the preliminary assessment decision within 20 business days.

The outcome from our preliminary assessment will be one of the following:

Application approved

Your sponsor’s application for a kind of medical device to be included in the ARTG has been approved. 

Now sponsors can legally supply your medical device.

Application selected for audit

Your sponsor’s application has been selected for audit.

Application refusal

Your sponsor’s application has been refused due to not passing preliminary assessment.

Step 10: Comply with post-market obligations

You have ongoing responsibilities as a manufacturer of medical devices supplied in Australia. 

You must provide us with information (usually via your sponsor) when required.

You must do the following record keeping once you start supplying your device:

Record keeping

You will need to keep some records, depending on the document and the type of device, for:

• up to 10 years, or
• for the lifetime of your device

You must do this even if you no longer hold an ARTG entry.

Vigilance and monitoring

Monitor the distribution, safety, performance, and quality of your devices. 

This includes: 

• Responding to customer complaints and adverse events.
• Seeking additional records, such as testing or additional analysis, to maintain evidence of conformity with the Essential Principles. This might be in response to emerging issues or complaints.
• Reporting adverse events within the legislated timeframes through the sponsor portal.
• Taking appropriate action about post-market complaints or signals, including investigating causes of problems, and fixing them

Comply with conditions

Compliance with any automatic or additional conditions of inclusion is your responsibility.

This includes: 

• responding within the specified timeframe to any requests for information or for samples
• submitting annual reports (where required)
• complying with conditions of any exemption

Market actions and tampering

You must:

• accommodate the procedure for recalls, product alerts and product corrections (PRAC) into your procedures
• undertake market actions where appropriate or directed by us. You and your sponsor should have an agreement so you can both handle recalls and other market actions.

Advertising

Comply with the Therapeutic Goods Advertising Code and other requirements for advertising.

Premises

Allow and facilitate entry and inspection of premises where your devices are manufactured or located.

Currency of information

Make sure information:

• in the ARTG is up-to-date and correct
• you must hold or must submit to us as part of an exemption, is up-to-date and correct.

Suspensions, revocations, lapses

Notify us within 60 days if the manufacturer evidence supporting your ARTG entry is:

• suspended
• revoked, or
• lapsed