Understanding the Free Sale Certificate (FSC) for Medical Device Import in India If you are importing a medical device into India, the Free Sale Certificate — commonly called the FSC — is one of the most critical documents you will encounter. Yet many importers run into delays, rejections, or confusion [...]
Introduction India’s regulatory framework for medical devices has advanced significantly under the Medical Devices Rules (MDR), 2017. If you are a manufacturer, importer, distributor, or hospital procurement team asking about the types of pacemakers approved in India by CDSCO, this pillar guide covers everything — from device classification and regulatory [...]
Introduction If you are a foreign manufacturer, an authorized Indian agent, or a domestic heart valve producer, understanding CDSCO heart valve registration in India is no longer optional — it is a legal necessity. India’s Medical Devices Rules, 2017 (MDR 2017), enforced under the Central Drugs Standard Control Organization (CDSCO), [...]
Introduction If you are a manufacturer, importer, or distributor of cardiac pacemakers in India, one question comes up almost immediately: how do I legally sell or import pacemakers here? The answer is straightforward — you need CDSCO pacemaker registration under the Medical Devices Rules, 2017 (MDR 2017). Without it, your [...]
