Install ExtensionGeM portal par Medical & Hospital Equipment procurement highly compliance-sensitive hoti hai.
Answer Capsule
In one line: Medical equipment procurement on GeM is governed by Indian regulatory frameworks under the Drugs & Cosmetics Act and Medical Device Rules (MDR 2017).
What matters: CDSCO device classification (Class A to D) determines regulatory licensing; international approvals (USFDA/CE) or ISO 13485 apply only when specified in individual tender requirements; AMC/CMC service terms must be carefully evaluated.
What can change: Device-specific regulatory pathways, CDSCO notifications, and tender compliance documents vary by medical device risk class and buyer specification.
Important Compliance Disclaimer
SahayakAI is an independent, private technology platform. We are not affiliated with, authorized, or officially connected with GeM, CDSCO, or the Government of India. Official portals are https://gem.gov.in and https://cdsco.gov.in.
1. Regulatory Compliance Framework (CDSCO & MDR 2017)
Central Drugs Standard Control Organisation (CDSCO) material ke according medical devices risk-based categories me classified hote hain:
- Class A & B (Low to Moderate Risk): Basic diagnostic tools, hospital furniture, surgical consumables.
- Class C & D (High Risk): Advanced imaging systems, ICU life-support, implantable devices.
Bidders ko respective device class ke required CDSCO licenses (Form MD-5, MD-9, MD-15 etc.) tender requirements ke matching attach karne hote hain.