Greetings Kusznier

A very interesting point. I agree that not much awareness is out there about Health Canadas enforcement of medical equipment licensing. Particularly because the end user of the medical device is exempted from the establishment licensing requirements ( www.hc-sc.gc.ca/hpb-dgps/...pret_e.pdf ). When a manufacturer applies for this license, they register their products as part of the water system in 3 categories---Pre-treatment, treatment and post treatment. All of which are regulated differently. For example the manufacturer may list PVDF as their material component of choice for a dialysis unit for licensing purposes (only material acceptable according to smoke and fire regulations) at $18/ft. In most practical circumstances, the dialysis unit may not see that as an effective use of their limited capital budget and choose an inert poly- material at $4/ft. It is a great idea to purchase an approved water system the end result is not everyone will conform, especially following current trends of government cuts to healthcare budgets.
Also I am curious where you read the classification of a water system as a class III device. According to the U.S. FDA, R.O. systems along with DDS are class II while high flux dialyzers, bloodlines etc are considered class III (www.osmonics.com/products/Page1111.htm ).
Bottom Line: Although all medical components in contact with the patient must comply with the current regulations, prudent use of resources must be exercised to ensure other important requirements to the therapy do not suffer due to careless fiscal management.