Canada - World Health Organization Regional Office for Europe
Canada - World Health Organization Regional Office for Europe
Canada - World Health Organization Regional Office for Europe
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<strong>Health</strong> systems in transition <strong>Canada</strong> 53<br />
Table 2.4<br />
<strong>Health</strong> <strong>Canada</strong>’s medical device classification under the Food and Drugs Act<br />
Device class Risk Examples Licence requirements<br />
I Lowest Reusable surgical instruments,<br />
bandages and laboratory culture media<br />
II Low Contact lenses, pregnancy<br />
test kits, endoscopes, catheters<br />
III Moderate Orthopaedic implants, glucose<br />
monitors, dental implants,<br />
haemodialysis machines<br />
IV High Cardiac pacemakers, angiogram<br />
catheters, cranial shunts<br />
Source: <strong>Health</strong> <strong>Canada</strong> (2007).<br />
2.8.6 Regulation of capital investment<br />
Device licence not required but<br />
establishment where device is made or<br />
distributed must be licensed<br />
Manufacturers require a <strong>Health</strong><br />
<strong>Canada</strong> licence be<strong>for</strong>e selling or<br />
advertising medical devices.<br />
Manufacturers are also required<br />
to renew licence annually<br />
In contrast to the federal regulation of medical devices, capital investments<br />
in health care are regulated at the provincial level. In most cases, <strong>for</strong>mal laws<br />
and regulation do not exist. Instead, P/T governments make an annual decision<br />
on capital projects through the budget process. Similarly, RHAs also make<br />
decisions based on their own annual budgets although P/T ministries of health<br />
make major capital investment decisions, such as new hospital construction.<br />
Independent hospitals make their own capital investment decisions but those<br />
that have contracts with RHAs will work in tandem with the RHAs on major<br />
capital expansions. Private health care organizations delivering non-medicare<br />
services, including long-term care, rehabilitation, dental and vision care<br />
services, are generally free to make their own capital investment decisions<br />
without regulatory oversight.<br />
In the 1990s, some provincial governments, such as Alberta and<br />
Saskatchewan, enacted laws to regulate the establishment and expansion<br />
of private facilities providing acute care services including surgery clinics<br />
(McIntosh & Ducie, 2009). Despite the rapid growth in private surgery clinics,<br />
most provincial governments have been slow to introduce comprehensive<br />
regulation and monitoring (Lett, 2008; Glauser, 2011).