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.
Ontario’s provincial government originally passed regulations in 2007 that would require electronic device manufacturers or their Canadian representatives to register with the ESA. Following industry lobbying efforts, however, enactment of the requirement was postponed indefinitely--and now, apparently, for good. Ontario provincial administrators have proposed that electronic medical devices obtain certification from ESA-recognized and Standards Council of Canada-accredited bodies prior to being approved for sale in the province, a requirement common across other Canadian territories. All other aspects of medical device regulation in Ontario would fall under Health Canada’s purview.
The proposal was sent out for public comment May 5, and the comment period closed on May 13.