Shamkris Global Group

Authorization for local supplier in Radiotherapy equipment

What is Application for Authorization for local supplier in Radiotherapy equipment

The Local Supplier Authorization for Radiotherapy Equipment is a mandatory approval issued by the Atomic Energy Regulatory Board (AERB) for any individual or organization intending to act as a local supplier of radiotherapy equipment and related devices in India. This authorization is governed under the Atomic Energy (Radiation Protection) Rules, 2004, and ensures that only qualified and approved suppliers are permitted to supply, install, and support radiation-based medical equipment. The approval is essential to maintain radiation safety standards, proper equipment handling, and regulatory compliance in healthcare facilities using radiotherapy systems.Before obtaining this authorization, the applicant must secure the required Type Approval and No Objection Certificate (NOC) from AERB for the specific radiotherapy equipment they intend to supply. These approvals define the categories of equipment that the supplier is authorized to distribute and support. Once approved, the local supplier is responsible for submitting periodic supply status reports to AERB, including details of hospitals or facilities where the equipment has been supplied. Suppliers are also expected to provide customer support programs such as calibration arrangements, maintenance coordination, and technical assistance to ensure continued radiation safety and operational efficiency. This authorization is specifically applicable to suppliers dealing with radiotherapy equipment and related radiation-emitting medical devices in India.

Who Can Apply for Authorization for local supplier in Radiotherapy equipment ?

 Any person or entity desiring to be deemed as a local supplier in the radiotherapy facility. These are specified under the Atomic Energy (Radiation Protection) Rules, 2004.

Pre-requisite:

  • Obtain an OEM authorisation letter
  • Provide details of radiation measuring, monitoring and quality assurance  tools
  • Provide details of trained service engineer
  • Obtain NOC for import/ supply of radiotherapy equipment
  • Obtain Type Approval from AERB

Documents Required for this Authorization for local supplier in Radiotherapy equipment

Act and Rules

Atomic Energy Act, 1962
Atomic Energy (Radiation Protection) Rules, 2004
Regulatory Requirements and Guidelines for establishing new Radiotherapy Facility

Role of Shamkris and Process of Authorization for local supplier in Radiotherapy equipment

Shamkris adopts a results-oriented approach to ensuring compliance with the mandatory requirements for obtaining the Application. With a simple and guided methodology, Shamkris helps organizations achieve the necessary application in a timely and cost-effective manner. Shamkris offers 100% support in advisory, guidance, and compliance, ensuring smooth processing for obtaining the application.

The Application acquisition process described below:

Advisory for the document required

Preparation of documents as per application & list of documents.

Certificate File

Inspection by the department if required

Certificate department

Certificate issued

Yearly Compliance if Applicable

Renewal when due

Who can issue Approval for Authorization for local supplier in Radiotherapy equipment

FAQ

Local Supplier Authorization is an approval issued by the Atomic Energy Regulatory Board (AERB) to individuals or organizations intending to supply, install, or support radiotherapy equipment in India.

Any individual, distributor, importer, medical equipment company, or business entity wishing to act as a local supplier for radiotherapy facilities can apply.

 

 

Yes. An authorization letter from the Original Equipment Manufacturer (OEM) is mandatory to prove that the applicant is officially authorized to supply and support the equipment.

 

Type Approval from AERB ensures that the radiotherapy equipment complies with the required radiation safety and regulatory standards.

 

Yes. Applicants must obtain a No Objection Certificate (NOC) from AERB for the import or supply of radiotherapy equipment before applying for authorization.

 

Commonly required documents include:

  • Proof of identity and date of birth
  • Aadhaar Card of employer
  • Proof of employership
  • PAN and TAN details of the institute
  • Government registration certificate
  • OEM authorization letter
  • Type Approval and NOC documents

 

 

Yes. Applicants must provide details of trained and qualified service engineers capable of installation, servicing, and maintenance of radiotherapy equipment.