Oct 21, 2014
Canadian regulators have updated their list of recognized standards pertaining to medical devices, affecting manufacturers applying to Health Canada for Medical Device Licenses (MDL).
Changes to the list include 15 new standards, 11 new editions of current standards and removal of 14 standards.
Additions, removals and changes to Health Canada’s list include standards from ISO, ASTM, IEC 60601 and CLSI. According to Ken Pilgrim, RA & QA Director at Emergo’s Canada operation, updates to the list will impact manufacturers in two major ways:
“Health Canada’s list of recognized standards is updated routinely on an annual basis, but companies seeking or maintaining MDLs should be aware of how these standards impact their compliance in Canada," says Pilgrim.
Health Canada has announced changes to its list of recognized list of medical device
Health Canada has announced several changes to its licensing processes over the past several weeks, some of which have been