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Uzbekistan Medical Device Registration

Uzbekistan Medical Device Registration

Introduction to Uzbekistan Medical Device Registration: Uzbekistan, with its rich cultural heritage and burgeoning healthcare system, offers ample opportunities for medical device manufacturers to introduce their innovations. However, entering this market requires a thorough understanding of the regulatory landscape governing medical device registration. In this comprehensive guide, we delve into the intricacies of registering medical […]

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Medical Device Software Validation and Verification

Navigating Medical Device Software Validation and Verification: An Extensive Guidance

Introduction to Navigating Medical Device Software Validation and Verification Medical devices play a crucial role in diagnosis, treatment, and patient care. These devices often rely on sophisticated software to function effectively, making software validation and verification a critical aspect of ensuring their safety, reliability, and compliance with regulatory standards. In this article, we’ll explore the

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Drug Device Combination Product

How to Regulate Drug Device Combination Product

Introduction: In the realm of healthcare, innovation often emerges at the intersection of different disciplines. One such area is the development of drug device combination products, which marry pharmaceuticals with medical devices to enhance therapeutic outcomes and patient experiences. However, bringing these products to market involves navigating a complex regulatory landscape that requires a thorough

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Performance Evaluation for IVD Device

Performance Evaluation for In Vitro Diagnostic (IVD) Device: Step-by-Step Process

Performance Evaluation for IVD Device In vitro diagnostic (IVD) devices play a crucial role in modern healthcare by aiding in the diagnosis, monitoring, and management of various medical conditions. These devices encompass a wide range of tests and technologies, from simple blood glucose meters to complex molecular diagnostic assays. However, before these devices can be

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Global Opportunities for Medical Device Manufacturers

Global Opportunities for Medical Device Manufacturers: Insights into India, LATAM, and African Markets

Overview – Global Opportunities for Medical Device Manufacturers In today’s era of healthcare innovation, regions like India, Latin America (LATAM), and Africa offer promising markets for medical device manufacturers. This blog delves into the opportunities and dynamics within these regions, providing valuable insights for manufacturers looking to expand their global presence. India: A Booming Healthcare

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FDA Unveils Comprehensive Strategy for Integrating AI into Medical Products

FDA Unveils Comprehensive Strategy for Integrating AI into Medical Products

An Overview: In a landmark move aimed at advancing the integration of Artificial Intelligence (AI) into medical products, the U.S. Food and Drug Administration (FDA) has revealed a comprehensive document titled “Artificial Intelligence and Medical Products: How CBER, CDER, CDRH, and OCP are Working Together”. This strategic blueprint delineates targeted priorities essential for harnessing AI’s

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cleanroom Setup for Medical Device Industry

A Comprehensive Guide to Setting Up a Cleanroom for Your Medical Device Industry

Introduction to Cleanroom Setup for Medical Device Industry: In the medical device industry, ensuring the highest standards of cleanliness and product sterility is paramount to producing safe and effective products. This is where cleanrooms play a crucial role. Cleanrooms are controlled environments designed to eliminate airborne contaminants, providing an atmosphere for sterile setting for manufacturing

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Online Submission of PSURs

Mandatory Online Submission of PSURs for Medical Devices Implemented

CDSCO Circular – Online Submission of PSURs The CDSCO has issued a circular mandating the online submission of Periodic Safety Update Reports (PSURs) for Marketing Authorization (MA) of Medical Devices and In-vitro Devices. This measure, effective from March 19, 2024, aims to simplify the regulatory submission process for PSURs. According to the circular, all applicants

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cdsco loan license

A Comprehensive Guide to Obtaining CDSCO Loan Licenses for Medical Devices

What is a CDSCO Loan License? A CDSCO Loan License, as per the Drug and Cosmetic Act of 1940, refers to a license granted by the licensing authority to an applicant without a production facility or production arrangements but to utilize necessary manufacturing facilities.  The Ministry of Health and Family Welfare (MoHFW) and the CDSCO

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CDSCO online safety reporting

CDSCO Implements Compulsory Online Safety Reporting for Medical Devices

CDSCO Mandates Online Safety Reporting for Medical Device Manufacturers New Delhi, March 19, 2024: Following suit with pharmaceutical regulations, the Central Drugs Standard Control Organisation (CDSCO) has made it mandatory for manufacturers of medical devices and in-vitro devices to submit safety reports online. The directive, issued by the Drugs Controller General of India, Rajeev Raghuvanshi,

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