Digital Health Technologies – Revolutionizing Healthcare
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Digital Health Technologies – Revolutionizing Healthcare

In a world where technology is advancing at an unprecedented pace, the integration of digital health technologies into the healthcare landscape has become increasingly vital. Recognizing the significance of this convergence, the U.S. Food and Drug Administration (FDA) has taken a significant step forward this month (October 2023) by establishing a new Advisory Committee on…

Essential Information for Class IIa & Class IIb Medical Device Listings 
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Essential Information for Class IIa & Class IIb Medical Device Listings 

Navigating the Latest TGA Amendments: Essential Information for Class IIa & Class IIb Medical Device Listings Ever since the shakeup of the European Union (EU) Medical Device Regulations (MDR) in 2017, the Therapeutic Goods Administration (TGA) have adjusted their dependence on utilising the EU as their basis for listing on the Australian Register of Therapeutic…

Clinical Evaluation EU-MDR requirements
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Clinical Evaluation EU-MDR requirements

Clinical Evaluation EU-MDR requirements  This article provides a brief overview of Clinical Evaluation requirements as described in the European Medical Device Regulation – EU MDR [Regulation (EU) 2017/745].  What is meant by the term ‘clinical evaluation’ in the EU MDR?  The EU Medical Device Regulation (EU MDR) defines clinical evaluation as “a systematic and planned…

ISO 22442 – Medical Devices containing animal materials
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ISO 22442 – Medical Devices containing animal materials

Certain medical devices utilize animal materials in their manufacture to provide performance characteristics that are more advantageous than non-animal-based materials. The use of animal material, however, carries the risk of transmitting infectious diseases when it is improperly collected, stored or processed (e.g. prion diseases). Transmissible Spongiform Encephalopathy (TSE) is a prion disease that can affect…

Unique Device Identification (UDI) system for medical devices in Australia
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Unique Device Identification (UDI) system for medical devices in Australia

What is a Unique Device Identifier (UDI)? Unique Device Identifier (UDI) is a globally unique series of characters for each medical device on the market to: The Unique Device Identifier of a medical device typically includes two parts: History of UDI The first concept of UDI was signed into US law and added as part…