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Clozapine is a prescription drug authorized for sale in Canada to manage symptoms of schizophrenia when other drugs have not helped. Clozapine was developed in the 1960s. In 1975, clozapine was removed from the Canadian market because of reports of life-threatening infections and deaths linked...

Requirements for manufacturers and importers for collecting medical device safety information and provide notification to Health Canada. A monitoring process should be in place to ensure compliance.

This guidance document was prepared to help medical device manufacturers understand and comply with sections 25, 39 and 61.4 to 61.6 of the Medical Devices Regulations. Two new requirements in the Regulations were added to ensure the continued monitoring of benefits and risks after a product is...