With the continual rise of COVID-19 cases, the healthcare facilities are witnessing shortage of respirators. Assessing the critical shortage and enormous demand for respirators, the global Regulatory agencies are swiftly initiating significant efforts to develop practical methods for decontaminating used respirators effectively.
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August 11, 2020 Medical Devices, Regulatory Affairs -
July 15, 2020 Medical Devices, Regulatory AffairsCOVID-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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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 16, 2020 Regulatory AffairsThe COVID-19 pandemonium demanded Regulatory agencies to set forth certain amendments and measures for smooth functionality of review programs and product approvals. At the same time, the pandemic has encouraged health authorities to take precautionary steps in Regulatory communications and meetings with all the stakeholders.
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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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April 23, 2020 Food and Food Supplements, Regulatory AffairsWith the number of ailments and stress levels rising in the current scenario, people are willing to instantly boost their immunity levels. But for most, the regular diet is far from building up the necessary.
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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.