COVID-19 lead to a global health crisis, imposing the greatest challenges for medical communities. The threatening patterns of pandemic transmission and rapid rate of contagion invoked an emergency need of diagnostic kits, Personal Protective Equipment (PPE), ventilators, etc., in the United States.
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July 15, 2020 Medical Devices, Regulatory Affairs -
June 16, 2020 Medical Devices, Regulatory AffairsClinical 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 11, 2020 Medical Devices, Pharmaceutical, Regulatory AffairsIn the face of COVID-19 emergency, the European Medicines Agency (EMA) established faster scientific advice, rolling reviews and accelerated assessments to expedite the development and approval of medicinal products. EMA’s foresight is to support the development and marketing authorization of safe, effective and high-quality therapeutics and vaccines at the earliest.
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June 10, 2020 Medical DevicesWith the wider spread of COVID-19, there is a raising alarm for ventilators shortage. Pursuant to the situation, Saudi Food and Drug Authority (SFDA) devised guidance for quick market entry of ventilators and its accessories, within KSA (Kingdom of Saudi Arabia).
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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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April 13, 2020 Medical Devices, Regulatory AffairsEver since the World Health Organization (WHO) has declared the COVID-19 outbreak as a pandemic, the global health authorities and life sciences organizations are quickly responding to the situation to see how they can make meaningful contributions.
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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.