L1 - Licence to manufacture, possess for sale or deal in ionising irradiating apparatus

Apply for L1 - Licence to manufacture, possess for sale or deal in ionising irradiating apparatus

National Environment Agency (NEA)

For Business Users only

This licence is only for business users with a registered Unique Entity Number (UEN).

Application Details

This licence is required for applicants intending to manufacture, possess for sale, supply, distribute, sell or deal in radioactive materials or devices containing radioactive materials.

FAQ

Do I need to apply for this licence?
This licence is required if you intend to manufacture, possess for sale, sell or deal in irradiating apparatus. Irradiating apparatus include, but are not limited to:
- X-ray equipment (medical or non-medical)
- X-ray equipment (fixed or portable)
- Charged particle accelerator
- Linear accelerator (LINAC)
- Cyclotron
- Synchrotron
- Synchrocyclotron
- Irradiator
- CT scanner
- Bone densitometer
- Gamma knife
- OPG or PA
- Ion implanter
- Lithotripter
- Scanning electron microscope
What conditions do I need to fulfil?
i. The company must have a valid UEN.
ii. The company must comply with the Radiation Protection Act and its subsidiary Regulations, in particular the Radiation Protection (Ionising Radiation) Regulations.
What supporting documents do I need to submit?
i. Technical specifications / brochures
ii. If a medical device is to be imported for local sale, HSA registration / authorisation must be obtained.
How soon can my application be processed?
Complete applications with the necessary supporting documents will typically be processed within 10 working days upon reception of the submission. Licence applications that require pre-licence inspections and/or licence applicants who are instructed to sit for a qualifying test may require a longer period of time (4 - 8 weeks or more).
How much does this licence cost and how long is it valid?
The licence costs $210 per year and is valid for 3, 6, 9, 12 or 24 months.
Who can I contact for further details?
For licensing enquiries, please contact the National Environment Agency Call Centre at 1800-2255632 or 1800-CALL NEA or (65) 6225 5632 (from overseas). You can also email us at contact_NEA@nea.gov.sg.
How do I pay for the licence fees?
Payment may be made online via Credit Card when submitting the licence application. GIRO payment is also possible for customers with existing GIRO arrangement with RPNSD. To set up a GIRO account, please complete and submit the GIRO application form found on the NEA website: https://www.eportal.nea.gov.sg > Categories > Radiation Safety > eServices and Forms > GIRO Application Form for Radiation Licences. Cheque payment will no longer be accepted. Licence fees paid or submitted are not refundable.
How do I change the profile information (e.g. contact details) associated with my radiation licences?
For company: Licence cannot be transferred to a different UEN. To change UEN, existing licences will need to be cancelled and reapplied under the new UEN.
To amend your company details (e.g. contact person name, contact number, email address) registered with RPNSD, please email NEA RPNSD with the current information to be amended and the updated information.
I need more details about import and export licence. Where may I find it?
In most cases, import and export licences, i.e. L7A/B, L8A/B and N4A/B, are to be applied through the TradeNet system by freight companies which handle the transportation of cargoes from one Country/Region to another. Before the applications for import and export licences are submitted through TradeNet, L1 and L2 licensee should ensure that their dealer licences, i.e. L1 or L2 are valid and have been updated to include the irradiating apparatus or radioactive material, and that they have obtained the relevant possession licence if the apparatus is for use at their premises. For more information on the items under import and export control, please refer to the following links: https://www.customs.gov.sg/about-us/national-single-window/tradenet/competent-authorities-requirements-for-controlled-items/national-environment-agency---radiation-protection-and-nuclear-science-department-rpnsd
https://www.customs.gov.sg/-/media/cus/files/about-us/annexes-and-appendices/appendix-c---items-under-import-export-control.pdf
What other approval is needed in order to supply or possess a medical irradiating apparatus?
Medical devices are controlled under the Health Products Act administered by the Health Sciences Authority (HSA). Radiation emitting medical equipment are required to be registered and/or authorised by HSA before the equipment can be supplied in Singapore. Your company should check with MDB/HSA concurrently to find out the relevant requirements when you are preparing for the radiation licence application. Certain types of radiation emitting equipment may only be possessed by medical and/or healthcare establishments, and may only be used by registered medical and healthcare professionals at places registered with the Ministry of Health.
Where can I find more radiation regulatory and licensing information?
You may refer to the radiation safety webpage on NEA's website.
Where is RPNSD located?
RPNSD (Radiation Protection and Nuclear Science Department) is a department within the National Environment Agency (NEA). Our office is located at the 3rd Storey of the Annex Block of Environment Building at 40 Scotts Road. The nearest MRT station is Newton. Our mailing address is:

Radiation Protection and Nuclear Science Department
National Environment Agency
Environment Building
3rd Storey, Annex Block
40 Scotts Road, Singapore 228231

Additional Information

Fees
Licence Fees: $210 per year.

Documents Needed

Irradiating Apparatus Information
Technical specifications, brochures etc.
HSA Medical Device Registration
For applications including medical devices, please attach HSA Medical Device Registration or proof of exemption from registration
Other supporting documents
Other relevant supporting documents

Requirements

Prerequisite Licence(s)
ACRA - Registration for Companies / Business