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Health Canada

US, Canadian regulators warn of potential medical device shortages following Sterigenics shutdown


  • The shutdown of a Sterigenics medical device sterilization facility in the midwestern US may disrupt supplies of hundreds of devices, according to US FDA and Health Canada.
  • US and Canadian regulators have issues recommendations for manufacturers seeking alternative sterilization sites for their devices.
  • Changing sterilization facility sites may affect manufacturers’ current FDA and/or Health Canada registrations.

Ontario Government Backs Off Requiring ESA Registration for Some Medical Device Makers

Last month, Ontario’s Ministry of Consumer Services issued a proposed amendment to the province’s product safety regulation that would exempt electro-magnetic medical devices from some oversight by the Electrical Safety Authority (ESA), Canada’s electronic safety regulator, so as not to duplicate authority already vested in Health Canada.