Medical Device Registration Patna
Medical Device Registration and Licensing under the Medical Devices Rules, 2017 (notified under the Drugs & Cosmetics Act, 1940) by the Central Drugs Standard Control Organisation (CDSCO, Ministry of Health & Family Welfare) and the State Drug Control Authority, Bihar (Patna HQ), legally permits entities to manufacture, import, distribute, or sell medical devices and IVD kits in India.
- Mandatory Regulatory Compliance under Medical Devices Rules, 2017
- Risk-Based Device Classification: Class A (Low), Class B (Low-Med), Class C (Med-High), Class D (High)
- State Licensing Authority (Drug Control Bihar, Patna) for Class A/B Domestic Manufacturing
- Central Licensing Authority (CDSCO Central) for Class C/D & Import Licenses
- Online Filing via Centralized SUGAM / CDSCO MD Portal (cdscomdonline.gov.in)
What is Medical Device Registration in Patna, Bihar?
Under the Medical Devices Rules, 2017, every medical device, diagnostic kit, surgical consumable, implant, and Software as a Medical Device (SaMD) sold in India must be registered and licensed by the Central Drugs Standard Control Organisation (CDSCO). Operating a medical device manufacturing plant, import business, or wholesale distribution network without valid CDSCO licensing is a punishable offense under the Drugs and Cosmetics Act, 1940.
Regulatory jurisdiction depends on the risk category and operation type:
1. Low & Low-Medium Risk (Class A & B): Domestic manufacturing licenses (Form MD-5) are granted by the State Licensing Authority (Assistant Drug Controller / State Drug Controller Office, Swasthya Bhawan, Patna, Bihar) after premises audit by Notified Bodies or Drug Inspectors.
2. Medium-High & High Risk (Class C & D): Domestic manufacturing licenses (Form MD-9) and all Medical Device Import Licenses (Form MD-15) are granted directly by the Central Licensing Authority (DCGI / CDSCO HQ).
3. Wholesale & Distribution: Local distributors in Patna must hold valid wholesale drug/device licenses (Form 20B/21B) issued by local drug inspectors.
Shree Meeracorp offers end-to-end regulatory consulting in Patna and Bihar for ISO 13485 QMS implementation, Device Master File (DMF) preparation, SUGAM portal filing, and audit clearance.