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
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
US Food and Drug Administration (FDA) Issue New Regulatory Guidance
The FDA has issued a new guidance to manufacturers detailing when to submit a new 510(k) for changes or modifications made to that manufacturer’s previously cleared medical devic
Harmonisation for Australia and NZ on the Horizon
Positive news for therapeutic goods manufacturers as the Australian and New Zealand Governments agree to resume plans for a joint scheme for regulation of therapeutic goods. The jo
