Canada Proposes Changes to List of Device Standards

May 8, 2015

Health Canada is proposing 52 changes to its list of recognized standards for medical devices, including the addition of 26 new standards and updates to nine others.

Seventeen standards are slated for removal because they are outdated or no longer relevant, the agency says.

Most of the new standards focus on cleanroom and controlled environment procedures, and aseptic processing of products. The updated standards cover topics such as cardiac pacemakers, infusion pumps, laser products, spinal implants and orthopedic implants.

Slated for removal are standards on electromagnetic compatibility test protocols for active implantable devices and requirements for medical electric equipment.

Comments are due July 6. Access the list of proposed changes at www.fdanews.com/05-11-15-HC-standards.pdf. — Jonathon Shacat