Australia’s Therapeutic Goods Administration (TGA) plays a big role in medical device approvals. If your company plans to sell a device in the Australian market, you can’t ignore the TGA. One of the most important parts of the process is the Clinical Evaluation Report (CER). But many businesses struggle with what it should include, how to structure it or when to start. That’s where TGA consultants can help.
Working with the right consultant can save you time, money and headaches. They know the rules, follow changes, and help you avoid rejection. This guide walks you through everything you need to know about consultants and CERs, with examples, insights and useful tips.
What Does a TGA Consultant Do?
TGA consultants help companies get their medical devices approved. They understand the TGA’s expectations and guide you step by step. Without one, you might miss important rules or submit documents that aren’t strong enough.
Here’s what they usually help with:
- Classify your device correctly
- Plan the submission timeline
- Write or review your Clinical Evaluation Report
- Manage TGA responses or requests for more data
These consultants often come from industry backgrounds. They’ve seen what works and what doesn’t. That real-world experience helps them keep your submission smooth and stress-free.
When you’re figuring out how TGA consultants guide product approval, remember that early planning is key. Many companies wait until problems pop up before calling a consultant. That’s too late. Bring them in at the start. This way, you’ll build a strong foundation and avoid mistakes later.
What Is a Clinical Evaluation Report (CER)?
A Clinical Evaluation Report is a key part of your medical device submission. It shows the TGA that your device is safe and works as intended. It proves that the benefits outweigh the risks. If the CER is weak, the TGA will likely reject or delay your application.
A CER usually includes:
- Clinical background and intended use
- A summary of clinical data (published studies, trials, post-market data)
- Risk/benefit analysis
- Justification for safety and performance claims
The tricky part is proving your device is as good—or better—than others already on the market. If you use similar devices as references, you need strong data to back up the comparison.
Understanding medical device regulations and the TGA approval process will help you avoid writing a CER that misses the mark. Don’t guess what the TGA wants. Work with someone who knows.
When Should You Start Working on Your CER?
Too many companies rush their CER near the end of development. That’s risky. If you wait until just before submission, you won’t have time to fix gaps. You might need more clinical data. That could delay your whole launch.
Start writing your CER early in the device development lifecycle. At the very least, start when your design is locked. This way, you can check if your clinical evidence supports your claims.
Here’s a simple plan:
- Draft a clinical evaluation plan early
- Gather literature and existing data
- Review gaps and plan for new studies if needed
- Build the CER step by step as data comes in
This method saves time later. You won’t scramble to find proof when the deadline is near. You’ll also know sooner if extra studies are needed, which avoids last-minute surprises.
Most importantly, early planning means avoiding costly mistakes in your TGA submission. That’s peace of mind you can’t buy later.
Common Pitfalls in CERs and How to Avoid Them
One major pitfall is vague claims. Many companies say their device is “safe” or “effective” without backing it up. The TGA doesn’t accept vague. They want proof.
Another issue is poor referencing. Some teams rely on old studies that don’t match the device well. Or they use data from products that are too different.
Then there’s formatting. CERs need to be clear, logical and follow TGA structure. If your report is hard to read or missing sections, expect questions from regulators.
How do you avoid all this?
- Use up-to-date, peer-reviewed data
- Match comparison devices closely
- Follow TGA guidance documents
- Hire a skilled consultant to review your CER before submission
Fixing a rejected CER costs more than doing it right the first time. A little more effort upfront can save weeks or even months later.
Example: A Mid-Sized Company and a Class IIb Device
Let’s look at a real-world example. A Brisbane-based medical company developed a wound healing device. They planned to register it as Class IIb. The product had good internal test data, but the team had no experience with TGA submissions.
They tried writing the CER in-house. Their draft had errors in structure, weak clinical comparisons and missing risk analysis. When they submitted, the TGA flagged the issues and asked for more information—twice.
After months of delay, they brought in a consultant. She rewrote the CER, added stronger studies and cleaned up the argument. The second submission went through without another question.
The delay cost them six months of revenue. That’s a painful hit they could’ve avoided with early help. This case shows why expert guidance is worth it—even for mid-sized or local businesses.
How Do Consultants Stay Current with TGA Expectations?
Consultants follow updates from the TGA closely. They track guidance changes, new document formats, or risk assessments. This matters because TGA rules don’t stand still.
Good consultants also:
- Attend industry events and workshops
- Network with regulators and other consultants
- Keep libraries of example CERs and submissions
Some consultants work across markets, too. They know how EU MDR or US FDA guidelines relate to Australia. That can help if your device is already registered elsewhere.
Staying current means better CERs. You won’t miss new requirements. You’ll also write reports that speak the TGA’s language—because the consultant already knows what the reviewers expect.
What Role Does Post-Market Data Play in CERs?
Post-market data is gold in a CER. If your device (or similar ones) has already been used safely, you can use that data to strengthen your case.
Examples of post-market data:
- Real-world usage reports
- Complaint and incident logs
- Clinical follow-up results
- Registry data
The TGA likes this kind of evidence. It shows how the device performs outside a controlled trial. But make sure the data is clean and traceable. Don’t cherry-pick.
Using strong post-market data reduces the need for new trials. That saves you time and money. A good consultant will know how to pull this data together in a way that matches the CER format.
What Happens After You Submit Your CER?
Once your submission goes in, the TGA assesses it. If the CER is clear and well-supported, you might get approval in weeks. But if the TGA finds issues, they’ll ask for more info or clarification.
That’s why good CER writing matters. The better your report, the faster the review. The TGA doesn’t like fishing through unclear documents.
After submission:
- Wait for initial feedback
- Respond to any questions quickly
- If needed, revise and resubmit the CER
Even after approval, keep the CER updated. The TGA expects periodic updates based on new data or post-market results. Your consultant can help manage that too.
FAQs
1) What is the most common reason TGA rejects a CER?
The most common reason is weak clinical evidence. Many companies try to submit based on bench testing or old data from different devices. That doesn’t fly. The TGA wants clear proof the device is safe and works for its intended use. If your CER lacks that, it will get rejected or delayed. Another issue is a poor comparison. If you claim your device is similar to another one, but you can’t show how, that’s a red flag. The TGA wants apples-to-apples comparisons. Finally, missing risk analysis sections are a problem. Safety must be assessed from every angle. You need to explain potential risks and how they’re reduced. If you don’t, the TGA can’t accept your claims at face value. Always make sure your CER is backed by good evidence, matches TGA formatting and tells a clear story.
2) How long does it take to prepare a solid CER?
It depends on your device and how much data you already have. For a low-risk Class I device, it might take a few weeks. For a high-risk Class III, it could take several months. The quality of your internal records also matters. If your test results are clear and well-organised, that helps. But if you’re still collecting data or chasing down studies, the process slows down. A consultant can speed things up by guiding what’s needed and writing sections while you focus on testing. The fastest CERs happen when planning starts early—ideally before device design is locked. That gives time to collect the right data and write without pressure. Waiting until the end makes it a rush job. Those often end up with errors, weak claims or TGA pushback. So, always plan ahead.
3) Do I need a consultant for every device I submit?
Not always. If your team has strong experience with TGA rules and has written good CERs before, you might manage on your own. But even then, a second set of eyes helps. For new or high-risk devices, it’s smart to work with a consultant. They know what changes have come in, how to write strong justifications, and how to avoid red flags. Think of them like insurance. They cost a bit upfront but can save you from months of delay. If your company is growing and you plan to release more devices, start building in-house knowledge. Ask your consultant to teach your team during the process. That way, next time, you might handle it in-house with more confidence.
4) How often should I update my CER?
The TGA expects regular updates, especially for higher-class devices. You should review and update the CER:
- When new clinical data becomes available
- After major design changes
- At least once every 1–2 years (for higher-risk devices)
Keeping it up to date shows the TGA that you’re monitoring your device’s performance. It also helps during audits or post-market reviews. Some companies set reminders to review their CER yearly. If you launch in new markets or gather new post-market data, update it right away. A stale CER is a risk. The TGA may see it as a sign of weak oversight. Updating often also gives you early warning signs. If new risks appear, you can act before they grow. Consultants can help keep your CER current with less stress on your team.
5) Can one CER be used for multiple markets?
Sometimes, yes—but with limits. A CER built for the EU under MDR can often be adapted for Australia. The TGA accepts global data, but only if it fits their format and expectations. That means you’ll still need to adjust:
- Device classification
- Regulatory references
- Risk/benefit arguments specific to Australia
Also, Australia’s population and healthcare system are different. You may need to show how your device performs in local settings. If your EU CER is strong, use it as a base. Then customise it for TGA submission. Consultants who work across regions are helpful here. They know what to keep, what to cut, and what to rewrite. Never submit a CER built for another regulator without making it TGA-ready.
The Final Word: Get Ahead, Stay Compliant
TGA submissions are complex. Clinical Evaluation Reports are one of the hardest parts. But with smart planning and the right guidance, you can stay ahead.
Working with expert consultants means fewer delays, fewer surprises and more success. It’s not about ticking boxes. It’s about proving your device is safe and works well—clearly and confidently.
If you’re serious about smooth submissions, work with specialists who’ve been there before. Visit R2 Pharma Solutions to connect with professionals who help get your product across the line, first time.
To learn more, please call us today on 1800 879 151 or leave an enquiry.