Health Canada releases step-by-step guidance on developing an effective Corrective and Preventive Action Plan (CAPA), consisting of three...

Canada: New fees and performance standards for medical devices effective 1 April 2020 Canada: New medical device incident reporting...

Canada: Medical device fees increased by 2% from 1 April 2019 Canada: ‘Medical Devices Regulations’ updated to refer to 2016 edition of...

Health Canada has revised the guidance document titled "Management of Applications for Medical Device Licences". This document outlines...

Canada: Non-compliant device labels may now be relabelled/corrected after importation Canada: Priority review process for device...

Canada: Changes to evidence requirements for Class II and Class III infusion pumps Canada: Applications for medical device...

Australia - Therapeutic Goods (Permissible Ingredients) Determination (No. 4) 2018 Brazil - Questions and Answers: Resolution RDC...

Canada: Further reductions to MDSAP audit durations have been announced for small companies Canada: Health Canada is adopting the Global...

Canada: Medical device fees increased by 2% from 1 April 2018 Canada: New Digital Health Review Division to be established Canada:...

Canada: Introduction of reduced MDSAP audit times Canada: Regulations affecting dental x-ray equipment have been amended Canada: Proposed...

Canada: Comments solicited on proposed new fees for medical devices and pharmaceuticals USA: Key provisions of the ‘FDA Reauthorization...

US: Minimal Manipulation and Homologous Use Products US: Manufacturers Sharing Patient-Specific Information from Medical Devices with...

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...

Canada: Medical device fees increased by 2% from 1 April 2017 Canada: Static magnets may not be promoted with medical claims Canada:...

Australia: Guidelines on Compounded Medicines and Good Manufacturing Practice (GMP) Australia: Guidelines on Code of Practice for...

Canada: Non-eCTD electronic-only format to be used for medical device regulatory activities Canada: Scientific and clinical content of...

Australia: Strengthening Monitoring of Medicines in Australia Canada: Notice: Guidance Document - Fees for the Right to Sell Drugs...

According to Health Canada, the Canadian medical device market regulator is planning to extend the deadline for commercially reprocessed...

Health Canada is preparing the process of adopting the Medical Device Single Audit Program (MDSAP) in place of the current Canadian...