Regulatory expectations for medical device risk management are evolving toward the need for “mature” systems and processes. Recent standard revisions also emphasize patient safety -...
Latest Changes to List of Recognized Standards in Canada
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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:
- In the design and design change process, when a firm needs to identify which standards to comply with to meet Health Canada requirements
- In preparing MDL applications or amendments for Class II, III and IV devices, where Declarations of Conformity listing only Health Canada-recognized standards are required
“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.