Operon Strategist – Page 27 – Operon Strategist

Revolutionizing Healthcare: Medical Device Industry Report 2023

Medical Device Industry – A Wrap-up to 2023 The 2023 medical device industry report showcases dynamic advancements, regulatory updates emphasizing safety and efficacy, and government schemes incentivizing research and manufacturing. Notably, the establishment of upcoming medical device parks promises revolutionary production capabilities and collaborative opportunities. This comprehensive report highlights pivotal industry shifts, governmental initiatives, and […]

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Medical Device CDSCO Import License for Testing Purpose

Medical Device CDSCO Import License for Testing Purpose: An Overview In the rapidly evolving landscape of healthcare, importing medical devices for testing purposes in India necessitates adherence to stringent regulatory procedures. The Central Drugs Standard Control Organization (CDSCO) oversees the importation of medical devices and issues import licenses MD-16 to ensure compliance with safety and

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Understanding the Significance of FORM MD-3, MD-5, MD-7, and MD-9 in CDSCO

Navigating India’s stringent medical device regulatory landscape necessitates a comprehensive understanding of pivotal documents, including FORM MD-3, MD-5, MD-7, and MD-9. These forms play a critical role in obtaining licenses for manufacturing and selling medical devices, ensuring adherence to Central Drugs Standard Control Organization (CDSCO) regulations. You can also check our service page on the CDSCO

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Parliament to Introduce Proposed New Drug Law

New Drug Law in Parliament The government is poised to introduce the Drugs, Medical Devices, and Cosmetics Bill, of 2023 during the current session of Parliament. This Bill aims to replace the 80-year-old Drugs and Cosmetics Act of 1940, consolidating and amending regulatory requirements for drugs, medical devices, and cosmetics across India. Notably, the proposed

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IVD CE Marking: Compliance Certification for In Vitro Diagnostic Devices in Europe

European IVD CE Marking Services In the realm of in vitro diagnostic (IVD) devices, obtaining CE marking for European market access is pivotal. Compliance with the European Union’s stringent regulatory standards ensures the safety and efficacy of these devices. With the introduction of the In Vitro Diagnostic Regulation (IVDR 2017/746) in May 2022, the landscape

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A Guide to Ace ISO 10993: Medical Device Biocompatibility

ISO 10993: Medical Device Biocompatibility Biocompatibility is the ability of a medical device or material to function as intended without causing harmful or unacceptable reactions in the human body. According to ISO 10993-1:2018, it refers to the device’s compatibility with biological systems, ensuring it performs safely in its specific application by triggering an appropriate host

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Guide to MHRA Medical Device Registration

Introduction to MHRA Medical Device Registration: Registering medical devices and in vitro diagnostic devices (IVDs) in the UK is a crucial step for manufacturers looking to market their medical devices in Great Britain. The Medicines and Healthcare Products Regulatory Agency (MHRA) oversees this process, ensuring compliance with stringent regulatory standards. How to Register Your Medical

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FDA’s Credibility Modelling Guidance for Medical Devices

FDA has recently released groundbreaking guidance known as the “Credibility Modelling Guidance.” This comprehensive framework marks a significant development in evaluating computational modeling within U.S. medical device premarket submissions. Credibility Modelling Guidance The guidance introduces a risk-informed approach that aims to enhance transparency and consistency in regulatory reviews of computational models used in medical devices.

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India’s Medical Technology Sector Projected to Surge to Rs. 2,177.9 Billion by 2026

Industry Report Overview A recently unveiled industry report delves into the status and future prospects of India’s medical technology market, spanning 2023 to 2032. It encapsulates global insights, covering developmental trends, competitive analysis, regional dynamics, and strategic pathways. Additionally, it scrutinizes methodologies, manufacturing processes, import/export dynamics, and market productivity. Anticipated Market Growth and Key Players:

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A Guide to Getting a CDSCO Import License for Japanese Exporters of Medical Devices

Overview – CDSCO Import License for Japanese Exporters Entering a new market holds immense potential for growth, especially for manufacturers of high-quality medical devices in Japan seeking expansion. India, with its thriving healthcare sector, presents a lucrative market ripe with opportunities. To navigate the regulatory landscape and facilitate entry into India, Japanese exporters can rely

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