To strengthen the regulations of medical devices in India, the Central Drugs Standard Control Organization (CDSCO) has released two final amendments to the Medical Device Rule 2017. The amendments are expected to provide more clarity on the scope of medical devices and establish an expedited registration route for certain devices.
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February 28, 2020 Medical Devices -
February 28, 2020 Regulatory Artwork Services, Medical Devices, Regulatory Labeling, Regulatory AffairsTo ensure high standards of quality and safety for medical devices being produced or supplied, the European Union (EU) has released a new Medical Device Regulation (MDR) in May 2017. As the three-year transition period for medical device manufacturers will come to an end from May 26th, 2020, organizations must relook at implementing compliant processes and procedures accordingly.
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February 27, 2020 Medical Devices, PharmaceuticalOn January 31, 2020, the United Kingdom (UK) officially left the European Union (EU) making the Brexit come alive. In the light of Brexit, the European Medicines Agency (EMA) and the Medicines and Healthcare products Regulatory Agency (MHRA) have released certain Regulatory guidelines to ensure both pharmaceutical and medical device manufacturers are ready for the transition period.
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January 29, 2020 Food and Food Supplements, Cosmetics Regulatory Services, Medical Devices, PharmaceuticalIt has been observed for long that innovation drives the life sciences industry, and this would continue perpetually. For the betterment of human health, there have been many innovative drugs/devices released into the market.
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January 29, 2020 Medical Devices, Publishing & SubmissionsThe United States Food and Drug Administration (USFDA), to enhance the submission process for medical devices, has introduced a final rule to replace the paper submissions with electronic submissions. The rule which was proposed in September 2018 is expected to come into effect in 2020.
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December 26, 2019 Medical Devices, Regulatory AffairsTwo years ago, in 2017, the Food and Drug Administration (FDA) identified a tentative list of Class II medical devices to be exempted from premarket notification requirements. The list came with limitations for certain type of devices then. Referring to the same, the FDA on Oct 24, 2019, announced the proposed final list of Class II devices to be exempted from 510(k) requirements.
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December 26, 2019 Food and Food Supplements, Cosmetics Regulatory Services, Medical Devices, Pharmaceutical, Regulatory AffairsInvention has no limits. It is a continuous process. With many medicinal products and medical device rolled out in the market, the year 2019 has been a boon for Life sciences industry. For good, the industry has seen a significant growth. All thanks to the governance of global health authorities.
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December 24, 2019 Medical Devices, Regulatory AffairsAs part of the EU’s Medical Devices Regulation (MDR), the Council of the European Union (EU) has again published a new Corrigendum and a set of corrections. The new corrigendum gives manufacturers of certain Class I devices an additional four years for transition and compliance.
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December 24, 2019 Medical Devices, Regulatory Affairs, Publishing & SubmissionsIn a recent notification, the South Korean national health authority - Ministry of Food and Drug Safety (MFDS) announced that the Agency no longer requires the submission of full summary technical documentation (STED) files for the registration of high-risk (class IV) medical devices.
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October 31, 2019 Medical Devices, Regulatory AffairsWith just six months for the EU Medical Devices Regulation (MDR) to come into full implementation, medical device manufacturers need to start and prepare for the significant changes coming up or they may be at a risk of getting their products removed from the EU market.