Health Canada publishes delayed regulations:
This article was originally published in Clinica
Executive Summary
Health Canada's new medical device regulations have been published in Canada Gazette I after a six-month delay. Once all comments have been reviewed, the final version of the regulations will appear in Canada Gazette II at which time they will become law (see Clinica No 728, p 8). Because of the delay, and assuming Gazette II appears in one year's time, the majority of regulations for Class II, III and IV devices will come into force on February 1st, 1998, and for Class I devices on February 1st, 2001.