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Changes
File:HC medical device FRN Form FINAL 2021-05-28.pdf (view source)
Revision as of 15:07, 1 June 2021
, 15:07, 1 June 2021This form is intended to be used by manufacturers and importers to report information concerning actions taken in certain foreign jurisdictions to eliminate or mitigate a serious risk of injury to human health related to the use of a medical device, as per sections 61.2 and 61.3 of the Medical Devices Regulations.
== Summary ==
This form is intended to be used by manufacturers and importers to report information concerning actions taken in certain foreign jurisdictions to eliminate or mitigate a serious risk of injury to human health related to the use of a medical device, as per sections 61.2 and 61.3 of the Medical Devices Regulations.
This form is intended to be used by manufacturers and importers to report information concerning actions taken in certain foreign jurisdictions to eliminate or mitigate a serious risk of injury to human health related to the use of a medical device, as per sections 61.2 and 61.3 of the Medical Devices Regulations.