REGULATORY NEWS & UPDATES

The ARQon Gazette News

      Global Regulatory & Quality Bulletin 
The ARQon Gazette is a compilation of latest updates in the medical device and drug industry. These updates might have an impact to manufacturers and other industry participants.
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December 4, 2019

  • USA: FDA medical device user fees for fiscal year 2020 increase by almost 6%

  • USA: Comments sought on possible exemption of powered wheelchair stretchers from pre-market notification

  • USA: Guidance documents issued on benefit-risk determinations

  • USA: T...

August 30, 2019

  • Canada: New fees and performance standards for medical devices effective 1 April 2020

  • Canada: New medical device incident reporting requirements for hospitals

  • Canada: Post-market surveillance requirements proposed for adoption

  • Canada: Guidance on pre...

June 28, 2019

  • Canada: Medical device fees increased by 2% from 1 April 2019

  • Canada: ‘Medical Devices Regulations’ updated to refer to 2016 edition of ISO 13485

  • Canada: Public to have access to clinical information on drugs and devices

  • Canada: Consultation held on...

March 29, 2019

  • Canada: Non-compliant device labels may now be relabelled/corrected after importation

  • Canada: Priority review process for device applications to be streamlined and expanded

  • Canada: Guidance on the requirements for recognising an MDSAP Auditing Organizatio...

November 19, 2018

Apple worked closely with the Biologics Consulting Group to attain approval for the De Novo request for their new ECG app on the Apple Watch. Apple received approval from the US FDA on 11 September, just one day before the big reveal for the new Apple Watch on 12 Septe...

November 5, 2018

  • Canada: Changes to evidence requirements for Class II and Class III infusion pumps

  • Canada: Applications for medical device Investigational Testing Authorisations (ITAs)

  • Canada: Use of Regulatory Enrolment Process using the Common Electronic Submission Gat...

September 4, 2018

  • Canada: Further reductions to MDSAP audit durations have been announced for small companies

  • Canada: Health Canada is adopting the Global Medical Device Nomenclature (GMDN)

  • Canada: Down classification of artificial larynx devices into Class I

  • Canada:...

May 23, 2018

  • 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 M...

February 2, 2018

  • Canada: Introduction of reduced MDSAP audit times

  • Canada: Regulations affecting dental x-ray equipment have been amended

  • Canada: Proposed amendment of rules concerning disclosure of information from clinical studies or investigational testing

  • Canada:...

January 1, 2018

  • Canada: Comments solicited on proposed new fees for medical devices and pharmaceuticals

  • USA: Key provisions of the ‘FDA Reauthorization Act of 2017’ relating to medical devices

  • USA: High intensity ultrasound systems for prostate tissue ablation classified...

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