UP Medical Device Registration
Medical Device Registration & Licensing authorizes manufacturers, importers, and distributors in Uttar Pradesh to legally produce, import, store, and sell medical devices and In-Vitro Diagnostics (IVDs) under the Medical Devices Rules, 2017.
- Class A & B Manufacturing Licence (Form MD-5)
- Class C & D Manufacturing Licence (Form MD-9)
- Medical Device Import Licence (Form MD-15)
- Registration for Wholesale & Sale (Form MD-42)
- Device Master File & Quality Management Audit
What is Medical Device Registration in Uttar Pradesh?
In India, medical devices and diagnostic products are regulated under the Medical Devices Rules, 2017 (MDR 2017) enforced by CDSCO (Central Drugs Standard Control Organization) and State Licensing Authorities (SLA / UP Food and Drug Administration).
Medical devices are categorized into 4 Risk Classes: Class A (Low Risk), Class B (Low-Moderate Risk), Class C (Moderate-High Risk), and Class D (High Risk). Manufacturing or selling notified devices without a valid CDSCO / SLA licence or Form MD-42 registration is a punishable offence.
Shree Meeracorp assists medical device startups, importers, healthcare manufacturers, and distributors in UP with device classification, ISO 13485 QMS audit preparation, Device Master File (DMF) & Plant Master File (PMF) drafting, CDSCO SUGAM portal filing, and handling Drug Inspector audit inspections.