Medical device post-market reviews: the process

The TGA conducts post-market reviews of medical devices. This helps us make sure your product continues to meet its legislative obligations.

We can review your Australian Register of Therapeutic Goods (ARTG) product anytime.

Some reasons for post-market reviews include:

• Detection of a trend or signal amongst post-market data held by us or other regulators. Data includes adverse event reports, annual reports, clinical publications, and device tracking registers.
• Information received from, or action taken by, other medical device regulators.
• A similar device currently in the ARTG has a safety or performance issue.
• Unresolved or repeated recalls.
• Literature review of available clinical evidence.

All classes of medical devices, including Class I (non-sterile, non-measuring), can be selected for post-market review.

The review

When undertaking a post-market review, we may choose to review any aspect of a medical device. This including:

• the sponsor
• the manufacturer
• ingredients or materials used in the device
• the product itself
• the instructions for use
• packaging and labelling
• clinical data relevant to conditions or the physical application of the device.

Under review

We will notify you when your product is being reviewed with:

• a written notice, and
• a request for information under section 41JA of the Therapeutic Goods Act 1989.

The letter will ask for specific information we need to do the review. It will be visible in your TGA Business Services (TBS) account in the Medical Devices Post Market Compliance Dashboard.

Time frames

The time frames for responding will be clearly stated in the letter.

Failure to comply will result in further regulatory action. This could include cancellation of your inclusion from the ARTG.

If you cannot meet the deadline, request an extension through the Medical Devices Post Market Compliance Dashboard.

Providing false or misleading information can lead to civil and criminal penalties.

Responding to requests for information

The letter you receive will specify:

• how you need to respond to us, and
• the information, documents, or samples required.

We'll ask you for documents and information through the compliance dashboard. The dashboard lets sponsors see any requests or notifications from us.

Requests and notifications may include:

• information and documents
• samples, and
• proposal to suspend or cancel entries from the ARTG.

For instructions, see Post market review compliance dashboard.

Next steps

After we have received all the information, we will review it and decide if:

• Further information is required
• Action is required (Regulatory or non-regulatory)
• The review is complete

Further information

Depending on what we need, we may ask for more information through a section 41JA notice.

For minor clarifications or supplementary information, we may email or phone you.

Action

If a review finds issues, we'll work with you to implement appropriate corrective actions to mitigate the risks associated with your product.

Outcomes of the review may be regulatory or non-regulatory and may include:

• amendments to the instructions for use
• design changes
• product recall
• suspension or cancellation of the device from the ARTG
• the imposition of conditions of inclusion such as:
  • further reporting requirements, or
  • restriction of use to patient cohorts or medical conditions.

Complete

When outstanding actions are complete, you'll get a written notification that the review is completed.

We can re-open a post-market review or begin a new review at any time.