N2 - Licence to keep or possess for use non-ionising irradiating apparatus

Apply for N2 - Licence to keep or possess for use non-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 buy, purchase, keep, store or possess for use a non-ionising radiation irradiating apparatus.

FAQ

Do I need to apply for this licence?
This licence is required if you intend to store, keep or possess non-ionising irradiating apparatus. These include, but are not limited to:
- Medical diagnostic imaging ultrasound equipment
- Fetal heart monitoring ultrasound
- Therapeutic ultrasound equipment
- High Intensity Focus Ultrasound Equipment
- Aesthetic ultrasound (cavitation) equipment
- Laboratory use ultrasound equipment
- Industrial use ultrasound equipment
- Magnetic resonance imaging (MRI) equipment
- Class 3b and Class 4 Industrial Lasers
- Class 3b and Class 4 Medical & Cosmetic Lasers
- Class 3b and Class 4 Entertainment lasers
- Embedded laser systems containing class 3b or 4 laser
- Laser pointers above regulatory clearance

Your organisation should apply for a new licence at least 2 weeks before and no earlier than 6 weeks before receiving, installing and commissioning the equipment. The serial number should also be known to you either through the purchase contract or the invoice.
What conditions do I need to fulfil to apply for a licence?
i. The company must have a valid Unique Entity Number.
ii. The company must comply with the Radiation Protection Act and its subsidiary Regulations, in particular the Radiation Protection (Non-Ionising Radiation) Regulations.
iii. To use a laser irradiating apparatus, there must be a user with an N3 licence or applying for an N3 licence to use the apparatus under this application.
What supporting documents do I need to submit?
i. Technical specifications / Brochures / Catalogues
ii. If a medical device is imported directly from overseas, HSA registration / authorisation and one of the certificates (US-FDA / Australia-TGA / Japan-MHLW / Health Canada / CE-(93/42/EEC) must be obtained.
iii. Site map on the location of installation of equipment should be submitted for MRI equipment.
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 one time licence cost for each equipment is $155 and is valid for 12 months. Subsequently, the recurring fee for each equipment will cost $65 for a period of 12 months.
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_Licence@nea.gov.sg with the current information to be amended and the updated information.
How should I indicate the amendments I want to make to a licence?
To make clear what kind of amendments is needed, please provide an overview of the amendment request in the free text area found in the licence amendment application, and also provide as a supporting document the details of the amendment requested in the following format.

Equipment: Model ABC (Serial number: nnnnnn)
Item Existing information New information
1 Location... Location...
2 ... ...
3 ... ...
4 ... ...
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.
What other approval is needed in order to supply or possess a medical device?
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 the Medical Device Branch, HSA (www.hsa.gov.sg) concurrently to find out the relevant requirements when you are preparing for the radiation licence application. It is advisable to submit both the HSA's authorization and NEA's licence application concurrently. Upon receiving the complete submission, both agencies will conduct a joint assessment of the medical device to determine if the device can be brought into Singapore for sale/use. 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.
What other things do I need to know about radiation licences?
i. There are special requirements and conditions for the use of laser for medical, aesthetics and cosmetic purposes. In particular, class 4 lasers for application on human beings can only be used by registered medical practitioners.
ii. Application for the N2 licence for an MRI facility will need to be accompanied by the 5-G line diagram and information on the quenching outlet
iii. For laser equipment used in cutting or marking of materials, take note that some of these materials (e.g. PMMA) may undergo thermal breakdown, releasing hazardous chemical controlled under the legislations administered by various Government agencies. Please ensure that the requirements stipulated under these legislations are complied with.
iv. Ultrasound equipment for application on human beings is subject to licensing controlled under the Radiation Protection Act and its Regulations, because of possible misused and potential adverse health effects.
v. All ultrasound equipment above 3 W/cm2 must be separately approved by RPNSD before it can be used on any human beings. In particular, High Intensity Focus Ultrasound Equipment cannot be used at any beauty salon
vi. Laser marking machine and laser engraving machine shall not be used at home.
vii. If Laser/Ultrasound equipment are showcased, displayed or exhibited in an exhibition/conference outside the premises of an authorised N1 holder, then the exhibition/conference organiser shall apply for N1 licence. In particular, note that laser shall not be energised unless additional authorisation have been obtained from the Radiation Protection and Nuclear Science Department.
Where can I find more radiation regulatory and licensing information?
You may refer to the radiation safety webpage on the NEA's website.
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.

Additional Information

Fees
Licence Fees: $155 per equipment, valid for 12 months.
Recurring Fees: $65 per equipment, valid for 12 months.

Documents Needed

Apparatus information
Equipment Brochure / Catalogue / Technical specifications of the equipment to be licensed
ACRA certificate or Printout
For new applicants, please provide a copy of ACRA certificate or printout
Certificate: US-FDA / Australia-TGA / Japan-MHLW / Health Canada / CE-(93/42/EEC)
Equipment certificate of equipment to be licensed issued by one of the listed organization listed below: US-FDA / Australia-TGA / Japan-MHLW / Health Canada / CE-(93/42/EEC)
HSA registration / authorisation
Documentation showing that the apparatus has been registered with or authorized by HSA
Floor Plan (For MRI)
5-G line diagram and information on the quenching outlet for MRI facility
Other Supporting Documents
Other relevant supporting documents

Requirements

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