Health Canada Incorporates Establishment License Fees in Compliance Guidance

Medical devicemakers in Canada will now have to pay a fee to renew their establishment licenses annually by April 1, or face cancellation and enforcement actions, according to an updated Health Canada guidance. The guidance, which took effect Aug. 10, incorporates a 2010 regulation on establishment licenses that is similar to the U.S. Food and Drug Administration’s Medical Device User Fee Act.
International Medical Device Regulatory Monitor