• FDA Proposes to Amend 21 CFR 820 to Align with ISO 13485
    August 12, 2022 Medical Devices

    The US Food and Drug Administration (US FDA) has proposed to amend the medical devices Quality System Regulations (QSR) under 21 CFR 820. The current QSR regulations date to 1978 and have been amended only once in 1996. This action, if implemented, will align 21 CFR 820 more closely with ISO 13485:2016, the international consensus standard for devices widely accepted by global Regulatory...

  • Significance of Quality Control in Medical Writing

    It is challenging for medical writers to ensure that their project’s content, style, and format are high quality. Even the best medical writers may make a mistake. Therefore, it is important to have a quality check of the documents. Quality Control (QC) experts look at a document with a set of “fresh eyes,” which can identify mistakes that an author might overlook. Hence, QC reviews...

  • Consultation of Companion Diagnostics (CDx) & Guidance on Procedural Aspect
    August 10, 2022 Medical Devices

    Companion Diagnostics (CDx) are In Vitro Diagnostic devices used in conjunction with therapeutic drugs to determine their suitability for the patients. To place the CDx in the European Union, the manufacturer is required to submit technical and other relevant documents to the Notified Body (NB) for technical and conformity assessment. The Notified Body (NB) would issue the conformity...

  • Regulation of Software as Medical Device (SaMD) in India

    The emergence of digital health technologies has fast-tracked the evolution of the healthcare sector. New-age healthcare products like wearables, telemedicine, and clinical decision-making tools use Artificial Intelligence (AI) and Machine Learning (ML) algorithms. Global Health Agencies, including CDSCO, are gearing up and devising new regulations to address the transformation.

    The...

  • Significance of ICSRs in Pharmacovigilance: The EU Perspective

    Developing novel and essential medicinal products has significantly increased the burden of monitoring and tracking the Adverse Drug Reactions (ADRs) and Adverse Events (AEs) of drug products. An Individual Case Study Report (ICSR) is collected at an individual level, which leads to causality assessment or a tilt in the risk-benefit ratio of a medicinal product to be determined distinctly. In...

  • eCTD Submissions and Regulatory Development Strategies

    Over the years, procedures for assembling and filing eCTD submissions have evolved tremendously. Non-adherence to the submission requirements may occur when documents are not relevant to fit seamlessly into the given eCTD format. In such scenarios, applicants are burdened with making last-minute amendments, which cause a delay in submission or, in an extreme case, a technical rejection of the...

  • AI-based Medical Devices and Regulations in South Korea
    August 1, 2022 Medical Devices

    The technological advancement is now an integral part of healthcare and Artificial Intelligence (AI) algorithms, along with other AI-powered applications supporting medical professionals in clinical settings. AI and Machine Learning (ML)-based Software as a Medical Device (SaMD) aid medical practitioners in decision-making for better patient care. South Korea’s Ministry of Food and Drug Safety...

  • Medical Device Registration in Japan & The Role of a Marketing Authorization Holder (MAH)

    Globally, the Health Agencies require foreign medical devices and IVD manufacturers to appoint a local representative. In Japan, under the revised Pharmaceuticals and Medical Device (PMD) Act, the In-Country Caretaker (ICC) system was replaced with Marketing Authorization Holder (MAH) system. Under this system, companies shall obtain a MAH license to get the device approval and market the...

  • Labeling Requirements for Cleaning Products in California State
    July 29, 2022 Chemicals

    Cleaning product labels are no different than labels for other consumer goods when disclosure of ingredients comes into play. Organizations should exercise safety practices that will protect the consumers and workers during consumption.

    The California Cleaning Product Right to Know Act of 2017 (US Senate Bill 258) was signed into law on October 15, 2017, and came into effect in 2020...

  • Spatial Arrangement in Pharmaceutical Labeling

    With an increase in self-medication, the demand to have drug labels provide as much information as possible is growing. In the pharmaceutical industry, customers and patients must be protected by a clear, concise label that provides information about medications. Drug labels must provide customers with a way to know more about their formulas, how they are used, and what to do if there is a...

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