CDSCO and AERB paperwork: what we handle, what you sign
A plain-English walkthrough of the Indian regulatory process for medical imaging equipment.
Every imaging system we install has a regulatory trail. For a typical MRI or CT, two agencies are involved: CDSCO (the Central Drugs Standard Control Organisation, the device regulator) and AERB (the Atomic Energy Regulatory Board, the radiation safety regulator). X-ray systems need AERB only. Blood bank equipment needs CDSCO only.
CDSCO
The CDSCO process is the registration transfer. When a refurbished system is imported or transferred to a new owner in India, the device registration has to move with it. The documentation chain includes the original Equipment Import License, prior registration certificates, and the new owner’s facility details.
We compile the file, you sign the declarations.
AERB
The AERB process has three steps:
- Layout approval. Floor plans of the proposed installation showing the equipment location, control room, and the structural shielding. Submitted before the equipment arrives on site.
- Equipment registration. Once the layout is approved and the system is installed, an application is filed to register the specific serial number of your equipment.
- Commissioning certificate. Issued after AERB surveys the installation and confirms the shielding and safety systems meet the approved layout.
For X-ray systems the process is similar but simpler, with no layout-approval step on most C-arm and mobile DR units.
Typical timelines
- CDSCO registration transfer: 4-6 weeks
- AERB layout approval: 3-4 weeks
- AERB commissioning certificate: 1-2 weeks after survey
What you sign
You sign three things: the CDSCO declaration of end-use, the AERB layout undertaking, and the post-installation radiation safety undertaking. Everything else we prepare and submit.
The whole process, start to finish, typically adds three to four weeks to the installation timeline. We schedule it to overlap with civil work so it doesn’t extend the project.