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Procedure NameProcedure for No Objection Certificate for Import / export of Irradiating apparatus or similar equipment such as X-ray Machine, Linear Accelerator
Description

Category

No Objection Letter

Responsible Agency       

Sri Lanka Atomic Energy Regulatory Council

Address: No. 977/18, Kandy Road, Bulugaha Junction, Kelaniya, Sri Lanka

Phone: +94 11 2987860

Email: officialmail@aerc.gov.lk

Legal base of the Procedure

Sri Lanka Atomic Energy Act no 40 of 2014

Processing time

10 days

Fee

Fee for No Objection Certificate

Fee without Tax 

Semi Government & Private Institutions 

Fee without TAX 

Fully Government Instituitions 

 

Rs. 6000/= 

Rs. 3000/= 

 

Required Documents

No.

Type of documents

1

Confirmation letter from the end user for the purpose of use of the item to which the No Objection is required

2

Copy of Business Registration Certificate of the importer. (This will not applicable to Government Institutes)

3

If no objection is required for irradiating apparatus or similar equipment or NMRA registration attached the following documents as applicable:

  • Letter of Authorization from the Manufacturer given to the importer to sell / distribute the item to be imported. 
  • Free Sales Certificate 
  • USA Food & Drug Administration (FDA) Certificate 
  • CE /IEC Certificate 
  • ISO certificate 
  • Technical details of the product manual / brochure 
  • Type approval certificate or similar document acceptable to the Council of the irradiating apparatus issued by the competent authority of the country of manufacture 

4

 If no objection is required for import of accessories / material / item etc. attached the following documents:

  •  Copy of proforma invoice or commercial invoice 
  •  Copy of Packing list 
  •  Copy of Airway Bill / Bill of Lading 

 

Process Steps

Step 1

Applicant should submit a duly filled application form together with aforesaid required documentation and forward it addressed to the Director General of Sri Lanka Atomic Energy Regulatory Council.

Step 2

Atomic Energy Regulatory Council reviews application and if it’s not complete informs applicant .

Step 3

Decision taken by Sri Lanka Atomic Energy Regulatory Council on the application is conveyed to the applicant within 10 working days on receipt of all requested information to assess the application.

 

 

CategoryProcedure

The following form/s are used in this procedure
TitleDescriptionCreated DateUpdated DateIssued By
(Form J-2) Application for issuing a No Objection Certificate for Import / export of Irradiating apparatus or similar equipment. Related to Irradiating Apparatus or similar equipment such as X-ray machine, Linear Accelerator or Accessories / materials / items which do not emit ionizing radiation.08-06-201808-06-2018 This is Dowload File
This procedure applies to the following measures
NameMeasure TypeAgencyDescriptionCommentsLegal DocumentValidity ToMeasure Class
Requirements for No Objection Certificate for Import / export of Irradiating apparatus or similar equipment such as X-ray Machine, Linear AcceleratorPermit Requirement Safe Handling, Import, Export of any and all radioactive materials are done through the Sri Lanka Atomic Energy Regulatory Council.The importer should fill this application for obtaining the no objection certificate for purpose of importation & registration of medical equipment at National Medicines Regulatory Authority.Sri Lanka Atomic Energy Act No. 40 of 201431-12-9999Good