Registering a medical device in Australia is a complex but crucial process that ensures the safety and performance of devices entering the healthcare market. Navigating the regulatory landscape of the Therapeutic Goods Administration (TGA) can be daunting, particularly for new manufacturers and innovators.

Navigating the complexities of product development, clinical development, regulatory services for product registration/ lifecycle management, quality/QMS, training and commercialisation requires a tailored approach that balances local requirements and global objectives.

Recent changes in TGA Medical Device Regulations In December 2020, TGA released a new Personalised Medical Device Guideline along with a suite of new names and definitions that have shaken up the niche and specialised Custom-made Medical Devices sector. The new guidance reflects amendments to the Therapeutic Goods (Medical Devices) Regulations 2002, meaning that compliance

Is Artificial Intelligence Becoming Too Smart for Regulators? AI is Everywhere and it isn’t that New! The term ‘artificial intelligence’ (AI) was first coined in the 1950s. Since then, this disruptive idea has come a long way from concept to reality. From enhancing photos for your social media page to detecting diseases from medical images

By now, we should all be very familiar with the new Form for providing Product Information (PI) for Australia. Each time you make a change to a PI, be it safety-related or otherwise, you’re required to provide the updated PI to TGA in the new format. The looming deadline for marketed product PIs to be

The appearance of misleading terms and claims on websites and social media has attracted the attention of the TGA. The Therapeutic Goods Administration in Australia (TGA) has advised that fines were imposed via the Federal Court for misleading advertising by Peptide Clinics Australia (Peptide Clinics Pty Ltd), to the tune of $10 million (for breaches …

If you’re advertizing therapeutic goods in Australia in 2019, there’s new legislation that is critical to your successful campaign/s.
We’ve been keeping up to date over the break to ensure we’re ready to assist our clients with all of their commercialization needs around the globe.