DRAFT CIRCULAR IV cannulas -availability of exemption under notification No. 6/2006 dated 1.3.2006

Exemption scope for cannulas clarified: IV cannulas used in peripheral vessels are not covered by the notification exemption.

The notification exempts cannulae described for aorta, vena cavae and intra-corporal spaces, but IV cannulas-being short, small-lumen devices for peripheral veins and arteries-are materially different in construction and intended use and thus are not covered by that description. Expert medical advice highlights anatomical and physiological differences between great vessels and peripheral vessels, and notes that occasional emergency or off-label use of IV cannulas in larger vessels or cavities does not justify classifying them as cannulae for aorta, vena cavae or intra-corporal spaces; therefore the exemption is not available to IV cannulas.