Varying Your Medical Device or IVD ARTG Entry – TGA Variation Process

Purpose of ARTG Variations

Once a medical device or IVD is included in the ARTG, sponsors must maintain accurate entry information. Any change to the device (e.g., design, materials, intended purpose, labelling, manufacturer details) or administrative information requires a formal variation application to the TGA. This ensures ongoing compliance with the Therapeutic Goods Act 1989, Essential Principles, and risk-based regulatory controls. Failure to vary when required may result in non-compliance, suspension, or cancellation of the ARTG entry. Source: Varying your medical device or IVD ARTG entry - TGA

Types of Variations

The TGA categorises variations based on impact and complexity:

• Administrative variations: Minor changes with no impact on safety, quality, or performance (e.g., sponsor name/address change, correction of typographical errors in intended purpose).
• Minor variations: Changes with low regulatory impact (e.g., minor labelling updates, addition of distributor details, small manufacturing site changes under certain conditions).
• Major variations: Changes with potential significant impact (e.g., change in intended purpose, design modifications, new indications, major material changes, addition of new models/variants).

Classification determines the evidence requirements, fees, and assessment pathway.

Application Process

1. Determine Variation Type:

   • Use TGA guidance tables to classify the change.
   • Consult TGA if uncertain (pre-submission advice recommended for complex changes).

2. Prepare Application:

   • Gather supporting documentation:
     • Technical justification/risk analysis.
     • Updated labelling/artwork.
     • Test reports or clinical data (for major changes).
     • Declaration of conformity (if applicable).
   • Complete the relevant variation application form via TGA eBusiness Services.

3. Submit and Pay Fee:

   • Lodge electronically.
   • Pay applicable fee (administrative often lower/no fee; major variations higher).

4. TGA Assessment:

   • Administrative/minor: Often expedited or self-assessed in some cases.
   • Major: Full technical review, may involve expert panels.
   • Timelines vary: administrative (days/weeks), major (months).

5. Outcome:

   • Approved: ARTG entry updated.
   • Rejected: Sponsor may address issues and resubmit.
   • Conditional: Additional conditions imposed.

Post-Variation Obligations

• Implement changes only after approval (or per transitional arrangements).
• Update supply chain, labelling, and records.
• Continue post-market surveillance and vigilance reporting.
• Notify TGA of any subsequent issues arising from the variation.

Practical Considerations

• Timing: Plan variations well in advance; major changes may require significant lead time.
• Multiple Entries: Group related variations for efficiency.
• Overseas Changes: Align with international approvals where possible (e.g., EU MDR changes).
• Consultation: Use pre-submission meetings for complex or novel variations.

Detailed classification tables, required evidence by variation type, application forms, fee schedules, timelines, and examples of common variations are provided in the official TGA user guide on varying your medical device or IVD ARTG entry. Source: Varying your medical device or IVD ARTG entry - TGA

This variation framework ensures the ARTG remains current, supporting safe and effective use of medical devices and IVDs in Australia.