What Is the CDSCO MD-14 Import License? The MD-14 is a Form under Schedule II of the Medical Devices Rules, 2017, issued by the Central Drugs Standard Control Organization (CDSCO) under the Drugs and Cosmetics Act, 1940. It grants legal permission to import notified medical devices — including a wide [...]
What Is EPR Registration and Why Does It Matter for Lithium-Ion Battery Manufacturers? If your business makes, imports, or sells lithium-ion battery packs in India, EPR registration is not optional — it is a legal requirement under the Battery Waste Management Rules, 2022 (BWMR 2022), notified by the Ministry of [...]
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 [...]
Introduction If you manufacture, import, or distribute cardiovascular medical devices in India, CDSCO registration is not optional — it is the law. The Central Drugs Standard Control Organization (CDSCO), under the Ministry of Health and Family Welfare, governs every cardiovascular device sold, used, or manufactured in India under the Medical [...]
Key Takeaways – CDSCO Manufacturer License for Oximeters: MD-7 & MD-9 Introduction If you are setting up an oximeter manufacturing business in India and your device falls under Class C — or if you are looking to produce oximeters through a Loan License arrangement — you are dealing with two [...]
Introduction If you are planning to import oximeters into India, you cannot skip the CDSCO Import License. The Central Drugs Standard Control Organization (CDSCO) is the apex regulatory body that governs the import of medical devices, including pulse oximeters, under the Medical Devices Rules, 2017. Without this license, your consignment [...]
Introduction If you’re in the business of importing drugs, cosmetics, or medical devices into India, you have probably come across the terms COS-1 and COS-2. And honestly, the confusion is understandable — both sound like certificates, both are part of the CDSCO registration process, and both are absolutely non-negotiable if [...]
