Operon Strategist – Page 3 – Operon Strategist

Top 5 Barriers to Global Market Entry for Medical Devices

Introduction Entering the global medical device market is a massive opportunity. With rising healthcare demands, aging populations, and advances in technology, the worldwide market is projected to keep growing. But manufacturers, whether startups or established companies, often hit roadblocks when trying to expand beyond their home country. In this blog, we will explore the top […]

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Asia Pacific Regulatory News | Malaysia-Singapore Medtech Pilot & CDSCO Updates

Asia-Pacific Roundup: Malaysia and Singapore Start Pilot to Fast-Track Medtech Launches

Asia-Pacific Regulatory News Malaysia’s Medical Device Authority (MDA) and Singapore’s Health Sciences Authority (HSA) have launched a six-month pilot program aimed at accelerating approvals for Class B, C, and D medical devices. Running from 1 September to 28 February, the initiative is designed to shorten review times, reduce duplication, and speed up patient access to

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Why Additive Manufacturing is a Game-Changer for Medical Technology

Introduction to Additive Manufacturing in Medtech Additive Manufacturing (AM), also known as 3D printing, is rapidly transforming the medical device industry by enabling faster development, greater flexibility, and patient-specific solutions. For medical device manufacturers, AM opens new possibilities—from designing complex implants to streamlining production workflows. But while AM creates opportunities, it also introduces new regulatory,

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Dynamic Risk Management for Software-Enabled Medical Devices

Dynamic Risk Management in Medical Devices Dynamic Risk Management for Software is becoming essential in today’s medical device industry. It is no longer just a regulatory requirement—it is the backbone of patient safety, compliance, and product success. With the rise of software-enabled medical devices, manufacturers face unique challenges: rapid design iterations, cybersecurity threats, integration of

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Centre begins talks on new rules for refurbished medical device imports

The Government of India has started consultations to frame new regulations for refurbished medical device imports. A high-level inter-departmental committee is currently reviewing data and seeking inputs from the Ministry of Health and Family Welfare (MoHFW), Directorate General of Health Services (DGHS), Central Drugs Standard Control Organisation (CDSCO), the Department of Pharmaceuticals, and key industry

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MHRA Launches Survey on In-House Manufacturing Exemption for Medical Devices

MHRA Medical Devices Survey on In-House Manufacturing Exemption The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has launched a new medical devices survey to collect feedback from health institutions on the in-house manufacturing exemption in the UK. This exemption, introduced in 2021, allows devices manufactured and used within health institutions to bypass certain regulatory

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Biological Testing Methods of Medical Devices

Introduction Medical devices come in direct or indirect contact with the human body, which makes safety a top priority. Any material used in a device can cause potential risks such as toxicity, irritation, or allergic reactions. To ensure safety and compliance, manufacturers must conduct biological testing of medical devices as part of the regulatory approval

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FDA Clinical Data Requirements for Medical Devices

FDA Clinical Data requirements for Medical Devices: An Overview Understand when clinical trials are necessary for U.S. FDA submissions such as 510(k), De Novo, PMA, and HDE, and how manufacturers can plan accordingly. The U.S. Food and Drug Administration (FDA) plays a vital role in ensuring that medical devices entering the U.S. market are safe

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Device Master Files (DMFs) in Medical Device Manufacturing

Importance of Device Master Files (DMF) in Medical Device Manufacturing Medical device manufacturing is a highly regulated and innovation-driven sector. As manufacturers introduce advanced technologies, ensuring product safety, quality, and regulatory compliance becomes increasingly vital. In India, the Central Drugs Standard Control Organization (CDSCO) plays a pivotal role in overseeing medical device regulation. One of

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FDA Issues Warning Letters to Medical Device Companies for CGMP Violations and Unauthorized Marketing

The US Food and Drug Administration (FDA) has issued warning letters to multiple medical device manufacturers for violating current good manufacturing practices (CGMP) and marketing devices for unapproved uses. Mectronic Medicale S.R.L. Cited for QSR and Unauthorized Claims On August 5, 2025, the FDA published a warning letter addressed to Mectronic Medicale S.R.L., an Italian

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