Updates to Medical Device Regulations
Various changes have been made to the regulation of numerous types of medical devices by the TGA, including software-based medical devices, prescription spectacle lenses, medical d
Highlights from the 24th Management Committee Meeting of the International Medical Device Regulators Forum (IMDRF) in Berlin, Germany
In September 2023, Berlin hosted the 24th IMDRF Management Committee meeting, chaired by the EU and attended by over 550 global participants over five days, revealing significant d
Summary of the TGA’s Guidance Document for Active Medical Devices
The TGA’s August 2023 guidance focuses on requirements for active medical devices, which are defined as devices that significantly convert energy to operate. This excludes device
New guidance documents published – Australian Therapeutic Goods Advertising Code
The Therapeutic Goods Advertising Code (the Code) sets out the rules which govern advertisement of therapeutic goods to Australian consumers. This regulatory framework made under s
Personal Protective Equipment (PPE) Regulation as a Medical Device by the TGA
Due to the COVID-19 pandemic, the demand for PPE has significantly increased. In response to the greater demand, the TGA has issued guidance on the regulation of face masks, gloves
Changes to the Australian Register of Therapeutic Good (ARTG) inclusion process for non-measuring, non-sterile Class I medical devices
The TGA has changed the inclusion process by which non-measuring, non-sterile Class I medical devices are included in the ARTG. The changes came into effect October 2020.
TGA’s Medical Device Regulatory Changing Landscape
In 2020, the TGA are implementing a range of changes to the medical device regulations due to a number of reasons; some of which include changes to the European device regulations
Overview of the role of Key Stakeholders in the Medical Device Regulations
The new MDR will apply across EU Member States from May 2020, under this regulation there are defined obligations which lie with the major stakeholders in the device lifecycle. The
Post Brexit Market Access for Medical Devices
With a Brexit deal or no Brexit deal still on the cards, when either outcome comes into effect, the UK will be considered a third country. Countries which are located outside the E
The Advertising Code 2018 vs. ISO 15223-1
Selling medical devices on global markets requires that labelling must comply with local region labelling and advertising requirements. Each country will have specific requirements
