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Canada: Medical device fees increased by 2% from 1 April 2018
Canada: New Digital Health Review Division to be established
Canada: Classification and licensing of high-level disinfectants and sterilants as medical devices
Canada: Adjustments to the MDSAP transition process
Canada: Strengthening medical device post-market surveillance and risk management
Canada: Updated guidance on the classification of health products at the device-drug interface
USA: Lynch syndrome test system classified into Class II
USA: Percutaneous nerve stimulator for substance use disorders has been classified into Class II
USA: Temporary catheter for embolic protection during transcatheter intracardiac procedures has been classified into Class II
USA: Class II classification for the non-absorbable, haemostatic gauze for temporary internal use
USA: Class II classification deemed appropriate for the surgical smoke precipitator
USA: Class II classification for the extracorporeal shock wave device for treatment of chronic wounds
USA: Revised rules for the acceptance of data from clinical investigations of medical devices
USA: Delay of effective date: when products made/derived from tobacco are regulated as drugs, devices or combination products; amendments to regulations regarding intended uses
USA: OTC denture repair kits exempt from pre-market notification (510(k)) requirements
USA: Technical amendments to the medical device regulations
USA: Post-market safety reporting for combination products
USA: New guidance for industry released on how to prepare a Pre-Request for Designation
USA: Revised guidance released on acceptance and filing reviews for PMAs
USA: Updated guidance published on the Refuse to Accept Policy for 510(k)s
USA: Policy clarification and 510(k) submissions for ultrasonic diathermy devices
USA: Two guidance documents published to support the development of NGS-based tests
USA: Proposed expansion of the abbreviated 510(k) programme to permit demonstration of substantial equivalence using performance criteria
USA: Medical Device Safety Action Plan
Click here for the full article on Global Regulatory Press.
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