AERB Manufacturing License and Type Approval for Diagnostic X Ray and CT Scan
We STAR NUKE provide AERB Compliance consultancy services to set up Manufacturing unit of medical diagnostic X ray equipment as AERB’s product classification.
- Radiographic equipment – Line frequency and High Frequency : 100 mA, 300 mA, 500 mA, 800 mA
- Dental X Ray Unit- Line frequency based Floor model IOP X ray and High frequency based Hand-held battery operated Dental X ray
- CT Scan refurbish unit or new brand unit
These services are handled by professionals who have affluent industry practice and skills of AERB compliances. We have team comprising Ex- AERB / BARC professional having expertise in AERB Regulatory compliance and clearance process for all types of Radiation Sources / Radiation Generating Devices to import, use and market in India.
Star Nuke takes project on turn-key basis.
For the Diagnostic X ray equipment Supplier: AERB Import NOC and Supply License and Type Approval of X Ray equipment which needs to be marketed in India.
For the Diagnostic X Ray Equipment Manufacturer: AERB Commercial Production License and Type Approval of Diagnostic X Ray equipment which needs to be marketed in India under MAKE IN INDIA project.
We take complete scope under us- A brief of work scope includes;
Delivering verification and validation of prerequisites to comply with AERB Safety codes for X Ray based Equipment - layout, design, construction and operation of IR FACILITY.
- Siting Requirements ref: AERB Safety Standard
- Engineered Safety Design Requirements
- Design and development of documents, procedures & SOP’s in accordance with Radiation Protection Act-2004 for X Ray equipment’s type and model
- License for Supply for Supplying imported DR X Ray equipment
- Commercial Production Licensing for DR X Ray Equipment manufacturing
- Commissioning and Operation
- NOC and Type Approval of X Ray Device to market in India
For any query in regard to AERB compliance, contact us through call or drop message through Whatsapp at +91-9079063129 / 6375604173 / 8955006276. Or See video for more detail