case study - therapeutic good hand sanitiser

In this case study scenario, the hand sanitiser will be supplied to the healthcare sector for use as either a surgical hand disinfectant or general hygienic hand rub in the provision of a health service.  The product will be regulated as a New Low Risk Medicine by MEDSAFE and require consent from them before it can be supplied and marketed. 

The landscape flow chart presented below is a representative example of the requirements, predominantly MEDSAFE, expected to apply throughout the pre-market life cycle (Scoping, Design, Development and Evaluation) of an antiseptic hand rub manufactured and supplied as a therapeutic good in New Zealand. After evaluation by MEDSAFE, and consent granted, the product can be supplied in New Zealand as a New Low Risk Medicine.