Operon Strategist – Page 12 – Operon Strategist

How End-to-End Solutions Simplify Regulatory Challenges in the MedTech Sector

End-to-End Solutions for Regulatory Compliance for Medical Devices and IVDs The medical device industry operates within a complex regulatory environment that demands strict adherence to quality, safety, and performance standards. For manufacturers, navigating these requirements is crucial not only for market access but also for ensuring patient safety and product efficacy. End-to-end regulatory solutions are […]

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CDSCO & ICMR Release Draft Standard Evaluation Protocols for issuing license for IVDs

New Delhi, January 6, 2025 – The Central Drugs Standard Control Organisation (CDSCO), in collaboration with the Indian Council of Medical Research (ICMR), has issued draft standard evaluation protocols for licensing in-vitro diagnostics (IVDs) under the Medical Devices Rules (MDR), 2017. These protocols aim to ensure quality and performance consistency of IVD kits in India.

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North India’s Largest Medical Device Park Near Noida Airport Set to be Established

Transforming India’s Healthcare Landscape: Medical Device Park Near Noida Airport The Indian healthcare industry is undergoing a revolutionary phase, fueled by an increased emphasis on indigenous manufacturing, cutting-edge technological advancements, and proactive government measures to minimize import dependency. A landmark initiative spearheading this transformation is North India’s first dedicated Medical Device Park at Sector 28,

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Medical Device Import to Russia: Boosting Bilateral Trade Between India and Russia

Russia is looking to expand its import portfolio from India, particularly in the field of medical devices. In a recent meeting of the Co-Chairs of the Russian-Indian Inter-Governmental Commission, the focus was placed on increasing imports, including ultrasound scanning apparatus, catheters, therapeutic respiration equipment, and artificial body parts, such as artificial teeth, dental fittings, and

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9 Effective Approaches to Navigate Challenges in the EU Medical Device Market Beyond 2025

Global Frameworks Offer Valuable Insights for Europe’s Medical Device Regulations Europe is navigating challenges in refining its regulatory systems, particularly under the Medical Device Regulation (MDR). As a major player in the global medical device market, Europe faces obstacles such as extended approval timelines, rising costs, and a dwindling number of notified bodies. These factors,

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5 Key Insights for Effective Medical Device Market Research

Tips for Successful Medical Device Market Research: An Overview Developing and marketing new medical devices is a complex and highly regulated process. Conducting thorough medical device market research is essential for reducing risks and ensuring successful product launches. However, challenges such as regulatory restrictions and high research costs can complicate the process. In this blog,

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Medical Device Equivalence: A Key to Regulatory Success

Understanding Medical Device Equivalence: A Strategic Pathway to Approval Equivalence can be a powerful strategy for medical device manufacturers, but for some, it’s more trouble than it’s worth. To determine whether equivalence is the right approach for your product, it’s crucial to understand its requirements, challenges, and potential pitfalls. What is Equivalence? Equivalence refers to

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India Begins Manufacturing 44 Advanced Medical Devices, Including MRI Machines and Linear Accelerators

Boosting Domestic Manufacturing Through the PLI Scheme India has commenced domestic production of 44 advanced medical devices, including Linear Accelerators, MRI machines, and CT Scanners, under the Government of India’s Production Linked Incentive (PLI) Scheme for Promoting Domestic Manufacturing of Medical Devices. Launched in 2020, the PLI scheme aims to boost indigenous manufacturing capabilities with

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Radiation-Emitting Medical Devices Testing

Parliamentary Committee Urges Reforms in Testing and Regulation of Radiation-Emitting Medical Devices

A parliamentary committee has raised serious concerns over the country’s capacity to test and regulate radiation-emitting medical devices, such as X-ray machines and MRI scanners. In its fifth report submitted to Parliament, the Standing Committee on Consumer Affairs, Food, and Public Distribution emphasized the urgent need for reforms in national testing infrastructure. The report highlights

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Mastering PSUR Compliance: A Guide to Post-Market Surveillance for Medical Devices

What is a Periodic Safety Update Report (PSUR) for Medical Devices? In the evolving regulatory landscape of medical devices, maintaining post-market vigilance is paramount. Among the essential elements of this framework is the Periodic Safety Update Report (PSUR), a critical requirement outlined under the European Union’s Medical Device Regulation (MDR). This report ensures ongoing safety

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