TGA Medical Device Reforms – Product Names Requirement Cancelled
The TGA have announced that a component of the medical device reforms outlined in the TGA blueprint will not go ahead. The initiative to record all devices included under a device
NZ Medical Device Recalls Remind Medical Device Suppliers to be Prepared
New Zealand (NZ)’s regulatory body for therapeutic goods, Medsafe, have issued a reminder to medical device suppliers to ensure they are suitability prepared for a recall should
Regulatory Strategy – Key to Success
The term strategy is defined as ‘a high level plan to achieve one or more goals under conditions of uncertainty‘. A Regulatory Strategy created by KD&A specifically for your or