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Introduction:As India’s medical device industry continues to expand, ensuring that devices remain safe and effective once they enter the market is of paramount importance. This is where Post-Marketing Surveillance (PMS) and Field Safety Reporting (FSR) come into play. Regulatory bodies, such as the Central Drugs Standard Control Organization (CDSCO), require medical device manufacturers to maintain […]

Introduction: Navigating the regulatory landscape for medical device manufacturing in India requires thorough compliance with the Central Drugs Standard Control Organization (CDSCO) guidelines. One critical aspect is the manufacturing site registration. The Sugam Portal, developed by CDSCO, is a game-changer in streamlining this process, enabling manufacturers to file applications and manage documents digitally. From a

Introduction: In recent years, India’s medical device industry has seen substantial growth, supported by key regulatory reforms and government initiatives. The Central Drugs Standard Control Organization (CDSCO), along with the Indian government, has introduced various measures to streamline medical device registration and manufacturing, creating a conducive environment for both domestic and international companies. As a

Introduction: The Indian medical device landscape has evolved significantly, with the Central Drugs Standard Control Organization (CDSCO) playing a pivotal role in regulating the approval and market entry of medical devices. For manufacturers, particularly those introducing innovative devices without a predicate, understanding the regulatory pathway is crucial. This blog delves into the CDSCO’s approach to

Introduction: India’s drug regulatory authority, the Central Drugs Standard Control Organization (CDSCO), has been at the forefront of ensuring the safety, efficacy, and quality of medicines, medical devices, and cosmetics available in the country. As the pharmaceutical industry continues to expand, CDSCO regularly updates its regulations to adapt to new challenges, enhance public health, and

Introduction: Navigating the regulatory pathways for high-risk medical devices in Mexico can be a complex yet crucial process for manufacturers seeking to introduce innovative medical solutions into the market. The regulatory landscape ensures that these devices meet the necessary safety, quality, and efficacy standards to protect public health. Understanding the regulatory framework set by Mexico’s