Two 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 Medical Devices, Regulatory Affairs -
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.
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October 30, 2019 Medical Devices, Regulatory AffairsAs the Brexit deadline is fast approaching, the occurrence of a no-deal Brexit is likely. In this context, the Medicines and Healthcare products Regulatory Agency (MHRA) of the UK has updated its no-deal Brexit guidance on the regulation of medicines, medical devices, and respective clinical trials.
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August 30, 2019 Medical Devices, Regulatory AffairsThe European Commission’s (EC) Medical Devices Regulation (MDR) and In-vitro Diagnostics Regulation (IVDR) have been the most significant developments for medical device manufacturers willing to enter the European market. These regulations will allow the EU (European Union) regulators to have the required control and oversight of the medical devices entering into the market.
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June 25, 2019 Compliance, Audit and Validation, Medical Devices, Publishing & SubmissionsIn December 2018, the United States Food and Drug Administration (US FDA) published the final guidance on Manufacturing Site Change Supplements: Content and Submission. Replacing the 2015 draft guidance, the final guidance clarifies the responsibilities of medical device manufacturers who are willing to change their manufacturing site for an approved device.
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May 30, 2019 Medical Devices, Regulatory AffairsOn May 15, 2019, Central Drugs Standard Control Organization (CDSCO) of India has published a notification regarding the classification of new devices, which are notified for regulation. As per the notification, the newly regulated medical and in vitro diagnostic (IVD) devices will be classified as per the provisions of Medical Device Rules – 2017.
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March 13, 2019 Medical Devices, Regulatory AffairsDo you know? Out of 5000 types of medical devices marketed in India, only 23 types are currently regulated by the Central Drugs Standards Control Organization (CDSCO).