North America - Aug 2019
Canada: New fees and performance standards for medical devices effective 1 April 2020 Canada: New medical device incident reporting...
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ARQon
Jun 28, 20192 min read
North America - Jun 2019
Canada: Medical device fees increased by 2% from 1 April 2019 Canada: ‘Medical Devices Regulations’ updated to refer to 2016 edition of...
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ARQon
Jun 28, 20191 min read
Management of Applications for Medical Device Licenses: Revised Guidance Document by Health Canada
Health Canada has revised the guidance document titled "Management of Applications for Medical Device Licences". This document outlines...
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ARQon
Mar 29, 20192 min read
North America - Mar 2019
Canada: Non-compliant device labels may now be relabelled/corrected after importation Canada: Priority review process for device...
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ARQon
Nov 5, 20182 min read
North America - Dec 2018
Canada: Changes to evidence requirements for Class II and Class III infusion pumps Canada: Applications for medical device...
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ARQon
Nov 5, 20181 min read
Drug - Dec 2018
Australia - Therapeutic Goods (Permissible Ingredients) Determination (No. 4) 2018 Brazil - Questions and Answers: Resolution RDC...
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ARQon
Sep 4, 20182 min read
North America - Aug/Sep 2018
Canada: Further reductions to MDSAP audit durations have been announced for small companies Canada: Health Canada is adopting the Global...
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ARQon
May 23, 20182 min read
North America - May 2018
Canada: Medical device fees increased by 2% from 1 April 2018 Canada: New Digital Health Review Division to be established Canada:...
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ARQon
Feb 2, 20184 min read
North America - February 2018
Canada: Introduction of reduced MDSAP audit times Canada: Regulations affecting dental x-ray equipment have been amended Canada: Proposed...
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ARQon
Jan 1, 20182 min read
North America - December 2017
Canada: Comments solicited on proposed new fees for medical devices and pharmaceuticals USA: Key provisions of the ‘FDA Reauthorization...
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ARQon
Nov 1, 20172 min read
Drugs - October 2017
US: Minimal Manipulation and Homologous Use Products US: Manufacturers Sharing Patient-Specific Information from Medical Devices with...
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ARQon
Sep 1, 20172 min read
Drugs - August 2017
US: FDA and Beyond – REMS 1.16 Subheading Instructions for eCTD M1 v2.3 (DTD 3.3) US: Manual of Policies and Procedures(MAPP) 6021.1...
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ARQon
Aug 24, 20171 min read
North America - May 2017
Canada: Medical device fees increased by 2% from 1 April 2017 Canada: Static magnets may not be promoted with medical claims Canada:...
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ARQon
Aug 24, 20172 min read
Drugs - May 2017
Australia: Guidelines on Compounded Medicines and Good Manufacturing Practice (GMP) Australia: Guidelines on Code of Practice for...
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ARQon
Apr 4, 20172 min read
North America - April 2017
Canada: Non-eCTD electronic-only format to be used for medical device regulatory activities Canada: Scientific and clinical content of...
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ARQon
Apr 2, 20172 min read
Updates on Drugs - April 2017
Australia: Strengthening Monitoring of Medicines in Australia Canada: Notice: Guidance Document - Fees for the Right to Sell Drugs...
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ARQon
Aug 1, 20161 min read
Compliance deadline for Commercially Reprocessed Medical Device to be extended
According to Health Canada, the Canadian medical device market regulator is planning to extend the deadline for commercially reprocessed...
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ARQon
Aug 1, 20161 min read
Transition Plan for the Medical Device Single Audit Program (MDSAP)
Health Canada is preparing the process of adopting the Medical Device Single Audit Program (MDSAP) in place of the current Canadian...
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