The Union Ministry of Health (MoH), India has released a draft Gazette Notification – Medical Devices (Amendment) Rules, 2021. These rules are an amendment to the original “Medical Devices Rules, 2017”, published on January 31, 2017, in the Official Gazette under the Notification No. G.S.R.78(E). The amendment rules read –
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March 1, 2021 Medical Devices -
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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February 16, 2021 Medical DevicesThe medical devices industry is considered as highly regulated. Hence, devising a right Regulatory strategy will be a potential approach and a great value-added contribution to avoid Regulatory roadblocks.
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February 9, 2021 Pharmaceutical, Medical Devices, Food and Food Supplements, Chemicals, Consumer Healthcare, Regulatory AffairsThe year 2020 has been unpredictable for all the industries across the globe, including life sciences industry. With the outbreak of COVID-19, the life sciences industry and global Health Authorities faced various challenging scenarios, which in turn affected their long-term Regulatory plans.
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February 9, 2021 Medical DevicesThe TGA has recently undertaken a post-market review of face masks included in the Australian Register of Therapeutic Goods (ARTG) and identified common areas of non-compliance against claimed standards in this review process.
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February 8, 2021 Medical Devices, Regulatory AffairsRisk management is an essential process for medical devices to ensure their safety and effectiveness. Medical device manufacturers must have established risk management processes to combat and reduce the risks, by performing thorough risk evaluations.
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February 8, 2021 Medical Devices, Regulatory AffairsWith the EU MDR (European Union Medical Device Regulation) deadline inching closer on May 26th, 2021, it is necessary for the device industry to be aware of the EU MDR 2017/745 regulation for Economic Operators (EOs). As per the regulation, a Manufacturer, an Importer, a Distributor, and an Authorized Representative (AR) are considered as Economic Operators (EOs).
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The year 2020 was a roller coaster for everyone across the world. With the outbreak of the COVID-19, global Health Authorities (HAs) have been working relentlessly to ensure that healthcare professionals and the general public have the best resources to fight this pandemic.
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January 25, 2021 Medical Devices, Regulatory AffairsSince the onset of Coronavirus Disease 2019 (COVID-19), Health and Human Services (HHS) has declared a Public Health Emergency. The US FDA, since then, has been releasing various enforcement policies to ensure continued supply of certain essential medical devices, which play a vital role in prevention, diagnosis, management and treatment of COVID-19 and associated co-morbidities.
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January 25, 2021 Medical Devices, Regulatory AffairsThe FDA has introduced “Safer Technologies Program for Medical Devices (STeP)” in line with the “Breakthrough Devices Program”, to facilitate timely access to certain devices and device-led combination products.