Category Archives: Medical Device
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
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 acquires Open Sesame Consulting
We are very excited to announce today the acquisition of Open Sesame Consulting by Commercial Eyes. Commercial Eyes is Australia’s leading pharmaceutical and medical device commercialisation consultancy. Commercial Eyes employs over 100 staff and this year celebrates 20 years of operation. Commercial Eyes provides a broad range of commercialisation services … Continue reading
PHARMAC prepares to take over the procurement of medical devices
Access to medical devices in New Zealand is changing The Therapeutic Products Bill will be published shortly, resulting in PHARMAC assuming responsibility for the procurement and funding of medical devices in addition to their current brief of medicines. This … Continue reading
NZ Regs Shake-up – what will become of medical devices?
The New Zealand Ministry of Health has announced that they are developing a new regime for the regulation of therapeutic products. Following the cessation of the Australia New Zealand Therapeutic Products Agency (ANZTPA), the New Zealand Ministry of Health is … Continue reading
