Operon Strategist – Page 22 – Operon Strategist

Medical Device Reporting Mandate in India

Indian Government Strengthens Medical Device Safety with New Reporting Mandate

New Circular Mandates Robust Adverse Event Reporting System for Medical Device License Holders An Overview: New Delhi, May 15, 2024 – The Ministry of Health & Family Welfare, through the Central Drugs Standard Control Organization (CDSCO), has issued a new circular on May 15, 2024, mandating all medical device license holders to implement robust systems […]

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The Essential Requirements for Software as a Medical Device (SaMD Compliance)

SaMD Compliance: An Overview In the dynamic realm of healthcare technology, the development of Software as a Medical Device (SaMD) demands rigorous adherence to essential requirements. From regulatory compliance to risk management and beyond, understanding these foundational pillars is vital for ensuring the safety and efficacy of SaMD products. Let’s embark on a journey through

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Top 10 Tips for Medical Device Assembly Quality Control

Medical Device Assembly Quality Control: An Overview In the realm of medical device assembly, maintaining stringent quality control standards is paramount. Here, we delve into the top 10 expert strategies to enhance your processes and ensure compliance, reliability, and continuous improvement. Meticulous Documentation for Regulatory Compliance: Thorough documentation of assembly steps is not just a

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Understanding Technology Transfer in Medical Devices

Technology Transfer in Medical Devices Technology transfer in medical devices encompasses the transfer of various elements, including intellectual property, design specifications, manufacturing processes, and regulatory documentation. It enables the translation of research breakthroughs and innovations into commercially viable products that can benefit patients worldwide. The process typically involves collaboration between academic institutions, research organizations, medical

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Keeping Pace with IVDR: MDCG Releases Updated SSP Guidance for IVD Manufacturers

MDCG Releases Updated SSP Guidance Manufacturers of In Vitro Diagnostic Medical Devices in Europe must take note of Revision 1 of the MDCG 2022-9 guidance document recently issued by the Medical Device Coordination Group (MDCG). This revision brings significant changes to the Summary of Safety and Performance (SSP) template for IVDs, reflecting the evolving landscape

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Deciphering US FDA Compliance for Medical Gloves: An Extensive Manual

Introduction to US FDA Compliance for Medical Gloves Medical gloves play a crucial role in healthcare settings, serving as a barrier against infection transmission and ensuring the safety of both patients and healthcare workers. However, the manufacturing, distribution, and usage of medical gloves are subject to stringent regulations set forth by regulatory bodies like the

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Ujjain Medical Devices Park Booming with Rs. 1,400 Crore Investment and 4,500 Job Opportunities!

Ujjain Medical Devices Park Has Received Investment Proposals Ujjain Medical Devices Park has attracted investment proposals exceeding Rs 1,400 crore from 28 different medical equipment and consumables manufacturers. The Madhya Pradesh Industrial Development Corporation (MPIDC) has allocated land to these industries, with notable newcomers including Samson Scientifics and Surgicals, Omexa Formulary Pvt Ltd, US Herbals,

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CDSCO Test License for Medical Devices in India (Form MD 12, And MD 13)

Test License for Medical Devices – Overview In India, individuals have the opportunity to produce limited quantities of medical devices categorized under Class A, Class B, Class C, or Class D by acquiring a Test License (Form MD-13) from CDSCO. These devices are designated for applications like clinical research, testing, evaluation, demonstration, or training. Read

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India Streamlines Drug & Medical Device Approval Process

An Overview: India embarks on a transformative journey to streamline the approval process for drugs and medical devices, setting the stage for rapid innovation and improved healthcare access. With clear guidelines and proactive measures, the nation is poised to revolutionize the regulatory landscape, ensuring timely approval of life-saving treatments. Accelerating Access: India’s Blueprint for Smoother

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CDSCO Important Update: Mandatory Registration of Class C and D Medical Devices (Transition to Licensing)

Mandatory Registration of Class C and D Medical Devices Regarding the transition from mandatory registration to a licensing regime for Class C and D non-notified medical devices, effective from October 1, 2023, per GSR 102(E) dated February 11, 2020, under the Medical Devices Rules 2017: Manufacturers and importers are reminded of the forthcoming shift, wherein

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