Maintaining a Quality Management System (QMS) is the foundation to demonstrate Regulatory compliance in the medical devices industry. QMS is a structured system of procedures and processes, covering all the aspects of design, manufacturing, risk management, supplier management, complaint handling, clinical data, storage, distribution and product labeling of medical devices.
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March 30, 2021 Medical Devices -
March 19, 2021 Medical DevicesIn the context of COVID-19, there is an increasing interest in understanding the PPE regulations. To meet the growing interest, TGA the Australian Regulatory Authority has issued a guidance, which covers an overview of how PPEs are regulated, information for PPE manufactures and the PPE standards.
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March 15, 2021 Medical DevicesAs part of the Safe Medical Device Act in 1990, the FDA mandated the Design History File (DHF), which contains all the development documentation pertaining to a medical device/product/diagnostic, which is generated by the design control process.
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March 12, 2021 Medical DevicesThe medical devices industry is considered highly regulated hence device manufacturers must adhere to a strict set of practices, known as, GxP or Good Practices (GMP - Good Manufacturing Practice, GDP - Good Distribution Practice, GLP - Good Laboratory Practice, GCP - Good Clinical Practice and many more).
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March 1, 2021 Medical DevicesThe 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 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 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).