Medical device industry has been a booming industry with new technologies being introduced from time to time and has been dynamic in terms of Regulatory landscape. The year 2020 has seen a major disruption due to the COVID-19 Pandemic and demanded the Health Agencies to gear up for addressing the pressing situation, thus impacting the Agency’s plan of action.
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January 5, 2021 Medical Devices, Regulatory Affairs -
October 22, 2020 Medical DevicesFace shields have gained utmost significance as the primary protective equipment to curb the spread of the COVID-19. Considered as a Personal Protective Equipment (PPE), face shield is made up of a transparent window or visor, that protects the face and associated mucous membranes (eyes, nose and mouth) against the potential exposure to infectious diseases.
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August 24, 2020 Medical DevicesConsidering the severity of the on-going Covid-19 global pandemic, Health Canada (HC) is consistently warning hand sanitizer manufacturers about the use of the right formulation and ingredients in their products. Recently, the Agency halted 12 hand sanitizer companies from selling their unsanctioned products in the Canada due to the presence of unapproved ingredients.
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December 30, 2019 Regulatory Affairs, Publishing & SubmissionsThe changing landscape of the life sciences industry makes it necessary for the companies to adapt to the global Regulatory requirements, immediately. Companies need to evolve themselves for the necessary transition with each mandatory requirement from the health authorities.
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September 27, 2019 Regulatory Affairs, Publishing & SubmissionsHealth Canada (HC) again postpones the mandatory deadline for Drug Master File (DMF) submissions in electronic Common Technical Document (eCTD) format. Referring to the authority’s May 2018 notification, the earlier deadline was Jan 1, 2019 which later got postponed to Sep 01, 2019.
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April 8, 2019 Regulatory Affairs, Publishing & SubmissionsHealth Canada (HC) announced the revision of the validation rules for Regulatory transactions in electronic Common Technical Document (eCTD) format and published them as Version 4.4 on March 6, 2019.
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February 20, 2019 Medical DevicesHealth Canada (HC) has one of the most stringent regulations for medical devices. To further increase the safety and effectiveness of devices, and optimize the health outcomes for end-users, the Canadian health authority (HA) is aiming to strengthen the current Regulatory framework. The three-part strategy announced recently as an action plan is the part of the same.
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December 27, 2017 Publishing & SubmissionsWe hope you have taken necessary inputs on Health Canada (HC) eCTD format and its content structure from our previous write up.
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December 7, 2017 Publishing & SubmissionsThe health authority of Canadian landscape, Health Canada (HC) has revised the submission requirements and mandated submissions to be in electronic format for certain filings post January 1st, 2018.
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May 25, 2017 Publishing & Submissions, Health Authority UpdatesWith the FDA concluded its mandatory first phase electronic submissions deadline, first question drug manufacturers could ask themselves is what’s next in line? Where else they can submit their data and which format they should get adopted to? With their target focused on global markets, we suggest to take one-at-a-time approach.