• EC Regulatory Options: Placing Medical Face Masks in the EU Market

    The 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. To be precise, the European Commission (EC) has clearly defined the medical face masks and proposed Regulatory options to place them in the EU market with short-term supply...

  • Food and Food Supplements - Claims and Substantiation

    Claims are an integral part of the packaging and labeling of any food product or a food supplement. They provide necessary information about the food product to the buyer to help them make an informed buying decision. Before moving forward to the importance of claims in food products, first let’s understand what are claims? Claims are statements or phrases on a product label/ pack or...

  • US FDA EUA and Post-EUA Regulations for Medical Devices – Insightful Webinar

    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. Hence, there is a pressing demand to fulfil the device shortages at the earliest, by...

  • 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...

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