The world of medical devices is a rapidly evolving landscape, constantly pushing the boundaries of innovation to enhance patient care and improve healthcare outcomes. Within the United States, the Food and Drug Administration (FDA) plays a pivotal role in ensuring the safety and effectiveness of medical devices entering the market. One crucial pathway for device […]
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Medical devices industry seeks more clarity on definition of manufacturer in draft New Drugs Bill, 2022 The domestic medical device industry suggested the definition of manufacturer need to be changed in New Drugs and medical devices and cosmetics Bill 2022 so that it cannot be misused in India context. AiMeD gives feedback to government on
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Introduction of EU MDR Human Factor Engineering Requirements: Medical devices serve a variety of purposes in the healthcare industry, including disease or injury diagnosis, prevention, monitoring, treatment, and alleviation. Medical devices are employed in a variety of contexts, including clinics, advanced medical facilities, and home-based systems. Medical devices offer a variety of benefits, but they
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About new CDSCO notification CDSCO (Central Drugs standard control organization) regulatory body, responsible for the regulations of medical devices in India, issued guidelines for the mandatory registration of Class A and Class B medical devices. The previous guideline clearly states that manufacturers or importers need to mandatory register their medical device within the given time-frame
In recent years, the medical device sector has seen great innovation and growth, with more than 200 million medical devices in use worldwide. For businesses looking to bring medical devices to the US market, this growth comes with significant risks and obstacles, notably on the legal front. Introducing medical devices into the US market can
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The European Commission issued a regulation which set out some common specifications for high-risk In vitro diagnostics (IVDs) classified as class D under IVDR. This is due to the fact that some of these high risk in vitro diagnostic medical devices do not have harmonized standards developed covering certain provisions of IVDR Annex I. Therefore ‘’to set
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Medicines and Healthcare Products Regulatory Agency(MHRA) regulates all medicines and medical devices in UK. After the exit from EU ,MHRA has opportunity in how medical devices and IVDs regulated in UK. MHRA announces few plans to improve patients health & encourage innovations. To meet the global standards they will carry the UKCA marking, a new
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Opportunities in Medical Device Manufacturing The medical device manufacturing industry in India is in its nascent stage. The medical device industry encompasses everything from patient monitoring to pain management. As the pandemic hits us, industry is facing so many challenges at the global level in terms of disruption in the manufacturing sector. Certain products, like
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The growth in the medical device usage has led to increase a complexity of making the medical device safe for human use. Risk management process need to establish by the medical device manufacturer to ensure device safety, usability & regulatory compliance. Medical device manufacturer shall establish, implement, document and maintain an ongoing risk management process
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MDCG has issued Q & A document to help manufacturer comply with UDI s (Unique device identification) requirement under MDR & IVDR. This guidance ( MDCG2022-7) contain near about 25 question regarding UDI rules for system & procedure packs, UDI labelling, UDI device identification, promotional packs and marketing samples. Few highlights from the guidance are
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