View Procedure

Procedure Name

Procedure for Approval for import of X-ray machines / Irradiating apparatus

Description

Category

Approval

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

Fee

	Maximum Period of Validity: 01 Year	Fee without TAX Semi Government &Private Institutions	Fee without TAX Fully Government Institutions
1.	Dental X-ray Machine / Tube	Rs. 8000/=	Rs. 4000/=
2.	All types of Diagnostic X-ray Machine /Tube	Rs. 12000/=	Rs. 6000/=
3	Cabinet X-ray Machine	Rs. 8000/=	Rs. 4000/=

Processing time

10 working days

Required Documents

No.	Type of documents
1	Dully filled Application Forms J-3 & J-4 and Annex I-2 if relevant.
2	A copy of Proforma Invoice or Commercial Invoice with the packing list.
3	A copy of Airway Bill / Bill of Lading.
4	A copy of Business Registration Certificate.
5	A letter from the end user.
6	Letter of Authorization from the Manufacturer given to the importer to sell / distribute the items to be imported.
7	Type Approval Certificate or similar document acceptable to the Council of the irradiating apparatus issued by the competent authority of the country of manufacture
8	Free Sales Certificate
9	ISO Certificate of the relevant product.
10	IEC / CE Certificate of the relevant product.
11	Other reports /certificates pertain the quality of the product
12	USA Food and Drug Administration (FDA) certificate
13	Technical details with the product manual of the relevant product.
14	A copy of NMRA Certificate of the relevant product. (if applicable)
15	If the machine is static or a mobile to be installed in a room, provide details as requested in attached application (AERC-PLAN-01). If the machine is used for industrial & research purposes, which is to be installed in a room, provide details as requested in attached application (AERC-PLAN-02) Or attach a copy of letter which approved the plan if approval for the plan is obtained

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 on receipt of all requested information to assess the application

Category

Import

The following form/s are used in this procedure

Title	Description	Created Date	Updated Date
(Form J- 4) Application for Approval of Sale/Transfer/Installation of X-ray Machine /Tube Imported to Sri Lanka	This is for the approval of sale / transfer / installation of x-ray machine/ tube imported to Sri Lanka.	11-01-2018	08-06-2018
Report on the quality of the x-ray equipment.(Annex I-2)	Only for used & re-conditioned machines.	11-01-2018	23-01-2018
(Form J-3) Application for Approval of Import of X-ray Machine /Tube	This is the application for Approval of Import of X-ray Machine /Tube	08-06-2018	08-06-2018
Room Plan 01 Diagnostic X- Ray (AERC PLAN 01)	Room Plan 01 Diagnostic X- Ray (AERC PLAN 01)	19-06-2018	19-06-2018
Room Plan 02 Industrial Radiography (AERC PLAN 02)	Room Plan 02 Industrial Radiography (AERC PLAN 02)	19-06-2018	19-06-2018

This procedure applies to the following measures

Name	Measure Type	Agency	Description	Comments	Legal Document	Validity To	Measure Class
Requirements for Approval for import of X-ray machines / Irradiating apparatus	General		Importer must be given authorization by the Sri Lanka Atomic Energy Regulatory Council to import X-Ray related equipment.	Importer must be given authorization by the Sri Lanka Atomic Energy Regulatory Council to import X-Ray related equipment.	Sri Lanka Atomic Energy Act No. 40 of 2014	31-12-9999	Good