Category Archives: Regulatory Services
Relating to Regulatory Services of Life Sciences Industry
Medical Devices: Reclassification framework of certain devices
As of the 25th November 2021, the Therapeutic Goods Administration (TGA) has commenced the implementation of revised medical device framework incorporating reclassifications for some medical devices. The medical device framework includes new regulatory requirements, to demonstrate the safety and efficacy … Continue reading
Administrator, Regulatory, Quality & Compliance
About us Commercial Eyes is the foremost life sciences commercialisation business in Australia and New Zealand. With a team of over 100 people and 20 years of expertise, we have assisted more than 650 pharmaceutical, medical device, diagnostic and consumer healthcare companies. … Continue reading
Commercial Eyes Recruiting: Consultant, Regulatory, Quality & Compliance
The Opportunity The Consultant works within the Regulatory, Quality & Compliance team to deliver a range of regulatory applications for Australia and New Zealand. The Consultant manages client projects, working closely with other members of the team, to deliver … Continue reading
Commercial Eyes recruiting: Associate Consultant, Regulatory, Quality & Compliance
The Opportunity The Associate Consultant works within the Regulatory, Quality & Compliance team to contribute to the regulatory, quality and compliance consulting practice. The Associate Consultant is responsible for the preparation and submission of a range of regulatory … Continue reading
New TGA framework to redefine personalised medical devices
This post will cover the recent changes brought to regulation of personalised medical devices, under a new TGA framework. Continue reading
Commercial Eyes Recruiting: Senior Manager, Regulatory, Quality & Compliance
The Company Commercial Eyes is Australia’s foremost Pharmaceutical and Medical Device commercialisation consultancy offering pre and post market advice and support to local and international companies operating in Australia & NZ. What we do – and the consistent excellence with … Continue reading
Coronavirus (COVID-19): Information on medicines and medical devices supply in Australia
The Therapeutic Goods Administration (TGA) has consolidated all the COVID‑19 information on their website to assist manufacturers and suppliers with accessing the latest information about the special regulatory requirements for the supply of medicines and devices (including exemptions) in Australia … Continue reading
Improved Consumer Medicine Information template
The TGA have now released implementation dates for the updated Consumer Medicine Information (CMI) template that was developed throughout 2019 to reduce complexity and improve readability. Newly registered medicines must use the new template from 1 January 2021, while previously … Continue reading
Hand sanitiser – What do you need to know to supply in Australia?
The COVID-19 pandemic has seen the TGA rapidly changing the regulatory landscape for in-demand products that can help reduce the spread of the virus. Given all the changes taking place, it can be difficult to ascertain exactly how product categories … Continue reading
Brexit – What’s the impact on medicines and medical devices supplied in Australia?
The long-awaited Brexit is underway with the UK exiting the EU on 31 January 2020 A transition period is now in effect until the end of 2020 with the possibility for extension. Its status quo for Australia during the transition … Continue reading
