CDSCO Medical Device Licensing
Under the Medical Device Rules (MDR), 2017, all medical devices and In Vitro Diagnostic (IVD) kits manufactured, imported, distributed, or sold in India must be registered and licensed by the Central Drugs Standard Control Organization (CDSCO) or the State Licensing Authority (SLA) to guarantee patient safety, quality, and clinical efficacy.
- Classification into Risk Categories: Class A, B, C, and D
- State Licensing Authority (SLA) Filing for Class A & B Devices
- Central Licensing Authority (CLA / CDSCO) Filing for Class C & D
- Device Master File (DMF) & Plant Master File (PMF) Drafting
- Notified Body Audit Coordination & ISO 13485 Compliance
How to Get Medical Device Registration in Lucknow?
Manufacturers, authorized Indian agents, distributors, and importers in Lucknow must secure appropriate statutory approvals through the CDSCO SUGAM / CDSCOMED online portal before commencing production, import shipments, or marketing operations.
The registration workflow requires device classification, obtaining test licenses (MD-12/MD-16) where required, compiling Device Master Files, Plant Master Files, ISO 13485 certification records, undertaking testing at NABL/CDSCO approved labs, and clearing on-site audits conducted by Notified Bodies or Medical Device Officers.
Shree Meeracorp provides end-to-end regulatory consulting in Lucknow—covering classification mapping, technical dossier preparation, portal submissions, inspection readiness, deficiency resolutions, and tracking until the Grant of Medical Device Licence.