Overview of CDSCO Medical Device Registration in Kolkata, West Bengal
Kolkata is Eastern India's largest healthcare and pharmaceutical trade market—housing major hospital networks, medical equipment manufacturers, IVD kit producers, and medical device importers. Under the Medical Devices Rules (MDR), 2017, no entity can legally manufacture, import, stock, distribute, or sell notified medical devices or In-Vitro Diagnostics (IVD) in India without obtaining a valid CDSCO Medical Device License or Registration.
Registration is managed through CDSCO's SUGAM online portal (`cdscoonline.gov.in`). Devices are classified into four risk categories: Class A (Low Risk, e.g., surgical dressings, thermometers), Class B (Low-Moderate Risk, e.g., hypodermic needles, suction pumps), Class C (Moderate-High Risk, e.g., hemodialysis machines, X-ray equipment), and Class D (High Risk, e.g., cardiac stents, heart valves). Applicants must prepare comprehensive technical dossiers, establish ISO 13485 Quality Management Systems, and undergo joint audit inspections by Drug Inspectors.
Shree Meeracorp provides turnkey medical device regulatory consultancy across Kolkata, Howrah, Hooghly, Durgapur, Asansol, and Siliguri—managing risk classification, Device Master File (DMF) compilation, SUGAM portal e-filing, ISO 13485 audit readiness, and liaison with CDSCO East Zone officers at Nizam Palace, Kolkata.