North America - May 2017

August 24, 2017

  • 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

Click here for the full article on Global Regulatory Press.

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