Canada: Medical device fees increased by 2% from 1 April 2017
Canada: Static magnets may not be promoted with medical claims
Canada: Updated guidance on ISO 13485 QMS certificates issued by Health Canada-recognised Registrars
Canada: Public release of clinical information contained in medical device applications
Canada: Consultation being held on HIV simple/rapid test kits
USA: Scott Gottlieb nominated to lead the FDA
USA: 2018 budget for the FDA could result in significant user fee increases
USA: Regulatory reforms being introduced by the Trump Administration
USA: Technical amendment to identification of manual gastroenterology-urology surgical instruments and accessories
USA: Class II classification for vibratory counter-stimulation devices
USA: High throughput genomic sequence analyser for clinical use classified into Class II
USA: Class II classification for the continuous glucose monitor secondary display
USA: Classification of tobacco-derived products as drugs, devices or combination products delayed over ‘intended uses’ concerns
USA: List of Class I devices that are now exempt from pre-market notification
USA: List of Class II devices proposed for exemption from pre-market notification
USA: Labellers of soft (hydrophilic) contact lenses granted further UDI compliance extension
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