Central Drugs Standard Control Organisation (CDSCO), the authority regulating Medical Devices in India has released two new notices on September 3, 2020, which include the classification of non-notified medical devices and in-vitro diagnostic devices (IVDs).
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September 16, 2020 Medical Devices, Regulatory Affairs -
September 11, 2020 Medical Devices, Regulatory AffairsBiological evaluation of medical devices is a mandatory requirement for successful registration of medical device in the country of interest. Major guideline available on this subject is, "ISO 10993-1:2018 - Biological evaluation of medical devices". In addition, majority of the global Health Agencies accept this specific ISO standard.
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August 26, 2020 Medical DevicesReducing the complexity of Regulatory submissions, the global Regulatory Authorities transformed all the submissions from paper to electronic format. Respectively, there are several electronic submission formats proposed by country-specific Regulatory bodies.
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August 11, 2020 Medical Devices, Regulatory AffairsWith 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 6, 2020 Medical Devices, Regulatory AffairsThe use of face masks is increasing due to the rapid spread of COVID-19. To meet the growing demand, different types of face masks are manufactured and released into the market, claiming to serve the medical purpose.
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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 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.