Role of the Person Responsible for Regulatory Requirements
As of 1 July 2024, new regulatory requirements for medical devices containing medicinal substances, or materials derived from animal, microbial, or recombinant sources will take ef
Medical Device Regulation (MDR) European Union (EU) 2017/745 Transition – What is required by the May 2020 deadline?
Some manufacturers who have existing medical device MDD certificates may not transition before May 2020 and retain their current MDR until expiry, however a significant change to t
Regulatory Requirements: The Basic Information for Australian Medical Device Manufacturers
To manufacture and sell a medical device in Australia, you must hold certification from the Therapeutic Goods Administration (TGA). Depending on the risk level of the device you ma
TGA Release Proposal Paper: Are Tighter Controls and Alternative Options for Conformity Assessment Ahead?
The TGA have released a proposal paper introducing changes which could shake things up for Australian and overseas medical and IVD device manufacturers. The paper explores changes
Regulatory Requirements: A Simple Guide for Australian Medical Device Distributors
So you’ve found a new medical device that is just what Australia needs? Follow these steps to better understand the regulatory requirements for selling medical devices in Austral
Early Warning Mechanisms for Australia and New Zealand
The Therapeutic Goods Administration (TGA) and Medsafe, the Australian and New Zealand regulatory authorities for medical devices (and medicines) are in the process of developing a
GHTF Release New Standard
In light of the recent PIP breast implant adverse events and other significant device recalls, the GHTF has finalised a new standard called N87 (based on a previous guidance docum
Hip, Knee and Shoulder Joint Reclassification – TGA Announce Regulation Changes
In light of the recent PIP breast implant adverse events and other significant device recalls, the GHTF has finalised a new standard called N87 (based on a previous guidance docum
International Medical Device Regulators Forum (IMDRF) Progresses
At a meeting held in Singapore the International Medical Device Regulators Forum (IMDRF) (initiated to carry out a similar role to the now disbanded Global Harmonisation Task Force
New EU IVD Regulations, Potentially In Line with Australian IVD Requirements
The European Commission is considering a number of key requirements, namely classification rules and clinical evaluation, for inclusion in the new IVD Regulation which will be pote
