With the Brexit commencement, from Jan 1, 2021, there have been a lot of changes in the UK’s medical devices regulations, which the executive Regulatory Authority in the UK – MHRA has devised. Medical device manufacturers willing to enter the UK market especially, England, Scotland and Wales, will have to follow the applicable MHRA UK regulations.
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September 15, 2021 Medical Devices, Regulatory Affairs -
September 1, 2021 Medical DevicesSri Lanka, being majorly driven by imported medical device products, offers a potential market to medical device manufacturers. The medical devices intended to be marketed in Sri Lanka must be registered with the National Medicines Regulatory Authority (NMRA).
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March 1, 2021 Medical DevicesHealth Canada has clarified its stand on the research use only testing kits related to COVID-19. Health Canada regulates the import and sale of medical devices and IVDs (In-vitro Diagnostic Devices) in the Canadian market.
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November 19, 2020 Medical DevicesBrazil’s National Agency of Health Surveillance (ANVISA) published a new Resolution of the Collegiate Board of Directors (RDC No. 423/2020). The new resolution declared the elimination of the Cadastro registration pathway for Class II medical devices and IVDs and substituted the same with a notification registration pathway (Notificação).
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October 13, 2020 Medical DevicesSince the commencement of Brexit transition timelines, the entire medical devices community is underway to understand its impact on future trade and Regulatory relations between the European Union (EU) and the United Kingdom (UK). As noted, the UK left the EU on January 31, 2020, as per the Withdrawal Agreement between both the countries.
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September 16, 2020 Medical Devices, Regulatory AffairsCentral Drugs Standard Control Organisation (CDSCO), the authority regulating Medical Devices in India has released two new notices on September 3, 2020, which include the classification of non-notified medical devices and in-vitro diagnostic devices (IVDs).