Steps to supply for device sponsors

Steps in the process

Step 1: Determine if your product is a medical device

Your manufacturer is responsible for determining if its product is a medical device. 

Confirm with your manufacturer that the product you want to supply in Australia is a medical device under the Therapeutic Goods Act 1989. 

Step 2. Understand your responsibilities

You should be aware of the following before continuing.

As the Australian sponsor for your medical device you:

• are responsible for meeting all ongoing requirements
• are the primary contact between us and your manufacturer
• must be able to get necessary information from your manufacturer. 

Step 3: The information is accessible

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

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.

You must be able to respond to these requests within the stated time frames.

You must allow and facilitate entry and inspection of premises where your devices are manufactured or located.

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.

See Section 41H in the Therapeutic Goods Act 1989 and Schedule 4 (Part 1) in the Therapeutic Goods (Medical Devices) Regulations 2002 for more information.

Step 5. Create an online account

Create an online account using TGA Business Services (TBS) portal.

This is the primary application portal. It is also used for ongoing compliance activities. You will manage your applications using the TBS portal.

Keep your account contact details current. This makes it easier for us to communicate with people in your organisation. For example, if you have staff join or leave your company, or there are changes to your authorised agents.

Step 6. Apply for a priority determination

Step 7. Know the class and category

Determine the class and category of your medical device.

Submit your manufacturer’s declaration of conformity with your medical device inclusion application for the following medical devices:

• a Class I medical device that is both:
  • not supplied sterile
  • does not have a measuring
  • a Class 1 IVD medical device
  • a medical device for export only 
  • a system that is a medical device where your manufacturer is using the special conformity assessment procedure
  • a procedure pack where your manufacturer is using the special conformity assessment procedure

For all other devices, you need to submit manufacturer evidence before making an application. This will allow you to use the same evidence for multiple applications.

Step 8. Submit manufacturer evidence

Your manufacturer evidence must be accepted by us before you can begin to draft your medical device inclusion application. 

Step 9. Apply to include your device in the ARTG

Follow the application steps to apply for inclusion in the ARTG. Refer to Submit your application for inclusion of a medical device.

You can withdraw your application at any time.

Step 10. Pay application fees

We'll send you an invoice and a confirmation once your application's submitted. 

• Application fees are non-refundable.
• We don't review applications until fees are paid.
• If you withdraw and resubmit (unaltered) your application, the fees will be transferred.

Step 11. Receive the outcome

Once you have submitted your application and paid your application fee, 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 application for a kind of medical device to be included in the ARTG has been approved.

You can now legally supply your medical device. See How to print your certificate of inclusion.

Application selected for audit

Your application has been selected for audit.

Application audits take additional processing and assessment time.  Fees apply to applications selected for a mandatory audit.

Application refused 

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

Step 12. Comply with post-market obligations

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

You must provide us with information 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.
• 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

Recalls and tampering

You must:

• Support your manufacturer's corrective measures when it comes to design or production
• notify us about any device safety, performance, and quality issues
• undertake recalls where appropriate or directed by us. You and your manufacturer should have an agreement so you can both handle recalls.

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

Step 13. Keep your ARTG entry current

It is important that information included in the ARTG is current. 

This is important for public health, regulatory and transparency purposes. When any information included in the ARTG has changed, you should consider if you need to apply for a variation to your ARTG entry.

There are many reasons you might need to vary your ARTG entries, including:

• the information entered on the ARTG is not correct or no longer correct
• your manufacturer’s details (for example, name or address) have changed
• the GMDN code is obsolete, and your manufacturer has decided to change to a more relevant GMDN code
• the intended purpose of your device has changed
• your manufacturer has added variants
• your manufacturer evidence identifier has changed
• your manufacturer has changed its Unique Product Identifier (UPI) or number of devices
• you want to vary the list of IVD medical devices included in your ARTG entry
• A particular performance characteristic for an IVD medical device we audited before has changed.