• Device Studies and MDCG Guidance on Safety Reporting

    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).

    Due to...

  • COVID-19 and Health Authorities’ Operational Amendments
    June 16, 2020 Regulatory Affairs

    The 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. The Regulatory bodies have proposedly altered few of their...

  • EMA’s Accelerated Regulatory Mechanisms for COVID-19 Products

    In 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.  As claimed, EMA...

  • SFDA’s Recognized Standards and Requirements for Ventilators
    June 10, 2020 Medical Devices

    With 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). The guidance specifies the requirements and recognized standards to obtain the Medical Devices Marketing Authorization (MDMA) for...

  • TGA ARTG: Step-by-Step Process for Including Thermometers

    The 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). Based on the significant number of applications received, the TGA devised guidelines to support the manufacturers and the...

  • TGA Standards for Personal Protective Equipment (PPE)

    COVID-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.

    Reliant to the therapeutic use, some PPEs are included in the Australian Register of Therapeutic Goods (ARTG)...

  • EU MDR Implementation Deadline Postponed for One Year

    In 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. Considering the current global scenario and the shortage of devices and other medicinal products, the EC...

  • FDA Guidance for Manufacturing Hand Sanitizers
    May 8, 2020 Regulatory Affairs

    The outbreak of coronavirus has become a global threat. With gradual spreading and increase in the number of infected persons, the COVID-19 has created a state of Public Health Emergency. To overcome this pandemic and ensure the safety of people, life sciences manufacturers all over the world are working continuously towards developing vaccines and solutions. However, in the meantime, the...

  • FDA’s New COVID-19 SPL Templates & Pre-requisites

    The COVID-19 pandemic has disrupted all the industries across the world. To handle the situation carefully, certain proactive measures have already been rolled out. One among them is to properly sanitize the hands with over the counter available drugs such as Hand rubs and Hand Sanitizers. To make such products adequately available in the market, the United States Food and Drugs Administration...

  • EMA Prefers Electronic Certificate Provision Over Printed Copies
    May 4, 2020 Regulatory Affairs

    With the prevailing COVID-19 pandemic, the Regulatory bodies are propelled to take quick and flexible Regulatory actions. Accordingly, EMA has called for a new system of issuing electronic certificates for human and veterinary medicines. Proposedly, the Agency will no longer provide printed certificates, but only the electronically signed and authenticated certificates. The EMA’s certification...

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