Medical devices – it’s not always straightforward

It can be a little daunting, confusing, or even just time-consuming when your product doesn’t fit nice and neatly into a pre-defined box!

For example, do you:

• wish to register a new medical device, however don’t have an EC Certificate? There may be other pathways to explore.
• have a product that looks like a medicine, but acts like a device? It may be a formulated medical device, and may be the subject of the TGAs recent reclassification guidance.
• wish to supply a pack containing both a medicine and a medical device (or devices)? There are several aspects to consider before deciding how best to achieve this.
• wish to market a new IVD kit?  Some of the components may be classified differently; it is therefore important to confirm the classification for each component in your kit.
• require a QMS to support your medical device? The ‘size and shape’ of your QMS should reflect your device, the intended purpose, your company size and future direction.
• use software in a healthcare setting?  It may be a medical device, with specific regulatory requirements and actions.
• supply implantable medical devices?  They may need to be reclassified – are you ready?
• need to consolidate your technical file?  You’ll need to consider your target markets, and if you can combine data for ‘families’ of similar medical devices.
• wonder if your design dossier will stand up to scrutiny? You may wish to conduct an independent audit to confirm.
• Intend to supply face masks and covid test kits in Australia? It is important to confirm that you hold enough of the right supporting data.
• have a medical device that does not meet the essential principles?  You may need to apply for TGA consent to supply this medical device.
• wish to supply a device that is custom made for an individual patient?  You may need to register this product and/or comply with specific safety and performance criteria.
• just need to ask a few questions to get started?

For these and a range of other medical device questions or concerns, call Jeanette on +61 (0)439 827 184 to discuss next steps.