Clinical investigations are fundamental to medical devices for safety & performance assessments during Regulatory submissions. Emphasizing the significance of how safety reporting in clinical investigations of medical devices should be performed, the European Commission’s Medical Device Coordination Group (MDCG) devised new guidance under Medical Devices Regulation (MDR).
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June 16, 2020 Medical Devices, Regulatory Affairs -
June 5, 2020 Medical Devices, Regulatory AffairsThe COVID-19 pandemic urged an immediate rise in the supply and demand of thermometers. Proposedly, the sponsors and manufacturers applied to Therapeutic Goods Administration (TGA) for the inclusion of thermometers in the Australian Register of Therapeutic Goods (ARTG).
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May 27, 2020 Medical Devices, Regulatory AffairsCOVID-19 outbreak necessitated an extensive study on the Personal Protective Equipment (PPE) regulations. Depending on the PPEs’ (face masks, gloves and gowns) therapeutic purpose, TGA has designed certain guidelines for manufacturers, consumers and healthcare professionals.
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May 22, 2020 Medical Devices, Regulatory AffairsIn the light of the international health crisis, on April 17, 2020, the European Commission (EC) proposed a one-year delay in the adoption of the new European Union Medical Device Regulations (EU MDR). Originally, the set of regulations were supposed to come into force by May 26, 2020.
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February 28, 2020 Medical DevicesTo 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 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 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.