The New EU MD Regulations on Notified Bodies. Will They Affect Australian Manufacturers?
In September 2012, the European Commission announced a proposal for regulation changes to medical devices and in vitro diagnostic medical devices. According to Medtech Insight News
Conformity Assessment limitations to be removed for Australian manufacturers of medical devices
The following announcement was made in October by the Therapeutic Goods Administration: ‘New regulations will be introduced to allow Australian manufacturers to obtain market app
Updated Standards to Keep Manufacturer’s Busy
This year will see the introduction of many new or revised harmonised standards relating to medical devices. Harmonised standards are used by medical device and IVD manufacturers t
KD&A – How Can We Help you?
KD&A provide expert medical device and IVD regulatory guidance to help launch products and access new markets. Our services include regulatory strategy, product registration for Au
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
New MEDDEV Documents Released
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
EU publish much awaited draft regulation for e-labelling of medical devices
The European Commission has finally issued it’s much awaited draft regulation on e-labelling, the final version of which is expected to be adopted by 14 December and come into fo
TGA Release Update Regarding Proposed Regulatory Framework Reforms
The European Commission has finally issued it’s much awaited draft regulation on e-labelling, the final version of which is expected to be adopted by 14 December and come into fo
