Medical Device Registration Delhi
Medical Device Registration under CDSCO (Central Drugs Standard Control Organisation) regulates the manufacture, import, sale, and distribution of medical devices and IVDs in India under the Medical Devices Rules (MDR), 2017.
- Class A (Low Risk - e.g., Thermometers, Surgical Dressings, Bandages)
- Class B (Low-Moderate Risk - e.g., Hypodermic Needles, Suction Equipment)
- Class C (Moderate-High Risk - e.g., Dialyzers, Oxygen Concentrators, Ventilators)
- Class D (High Risk - e.g., Cardiac Stents, Pacemakers, Implantable Devices)
- CDSCO SUGAM Online Portal Registration & License Grant
What is Medical Device Registration in Delhi?
In India, the Central Drugs Standard Control Organisation (CDSCO), headquartered at FDA Bhawan, Kotla Road, New Delhi, is the central national regulatory authority governing medical devices and in-vitro diagnostics (IVDs).
Under the Medical Devices Rules, 2017, no medical device or IVD can be manufactured, imported, or sold in Delhi NCR without an approved CDSCO Manufacturing License (Form MD-5 / MD-9) or Import License (Form MD-15). State Licensing Authorities (Drugs Control Department, Govt. of NCT of Delhi) govern Class A and Class B manufacturing licenses, while the Central Licensing Authority (CDSCO HQ) regulates Class C and Class D devices.
Shree Meeracorp assists medical device manufacturers, importers, and distributors in Delhi NCR with risk classification, Device Master File (DMF) preparation, ISO 13485 QMS documentation, Notified Body audit coordination, and filing online applications on the CDSCO SUGAM portal.