Ref - National Environment Agency

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Ref. N2
Radiation Protection and Nuclear Science Department
National Environment Agency
Environmental Building, 3rd Storey, Annex Block
40 Scotts Road, Singapore 228231
Email: Contact_NEA@nea.gov.sg
Website: http://www.nea.gov.sg
RADIATION PROTECTION ACT 2007
APPLICATION FOR A LICENCE TO HAVE IN POSSESSION
A NON-IONISING RADIATION IRRADIATING APPARATUS
This form will take approximately 15 minutes to be completed.
Every section of the application form MUST be duly completed. “N.A.” should be used when appropriate.
Application form without the details of the irradiating apparatus, incomplete application form, or incorrect payment will
result in the rejection of this application.
For payment by cheques, the accompanying cheque must be submitted together with the completed application form,
failing which the form will not be processed.
1.
Particulars of the organisation applying for the Licence (Local company/institute only)
Company stamp
Name of organisation:
Division/Department:
Address:
NIR Code (if available):
Nature of business:
Contact person:
Tel No.:
Designation:
Fax No.:
Email:
Company Unique Entity Number (UEN):
2.
Particulars of the company from which this irradiating apparatus was bought
Name:
Address and country:
Contact person:
3.
Tel No.:
Email:
Particulars of the irradiating apparatus for which licence is sought
For medical apparatus imported directly from overseas, please submit certificates/documents showing that the equipment is
already registered with the following governmental agencies: US-FDA, Australia-TGA, Japan-MHLW or Canada Health, or
CE certified to the EU medical directive 93/42/EEC. Also note that the requirements stipulated in the Health Products Act
need to be complied with.
Maker / Manufacturer
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Country of origin
Model name & number
Serial number
1
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4.
Purpose of the irradiating apparatus for which licence is sought
*Type:
( ) Ultrasound
(
) Magnetic Resonance Imaging
(
) Lasers
This irradiating apparatus is to be used in/for:
 Medical/Dental Surgery
 Dental Cleaning
 Industrial
 Medical Diagnostic
 Veterinary
 Class-Room for Demonstration
 Medical Therapeutic
 Entertainment / Show
 as a Display Set only at Exhibitions
 Research on Humans
 Non-Medical† Research Laboratory
 Others Purpose (Please specify):
† Medical
* Please tick one.
means that the equipment is to be used on human beings.
LASER
Classification of laser: (Class 1, 2, 3a, 3b or 4)
(Please put the classification of embedded laser if exists)
Type of laser (e.g., CO2, HeNe, Nd-YAG, KrF, GaAsAl, etc.):
Wavelength (in nm):
nm
Radiation mode: (pulse / continuous wave)
Maximum power for continuous wave laser:
(For pulse laser)
Pulse repetition rate:
Maximum power:
Pulse width or duration:
Average power or energy:
ULTRASOUND
Ultrasound frequency (in kHz or MHz):
kHz / MHz
Maximum ultrasound power (W):
Maximum ultrasound intensity (in W/m2):
Radiation mode (for medical application):
a) CW / amplitude modulated wave
b) A-mode / B-mode / M-mode / real-time / doppler-mode
MAGNETIC RESONANCE IMAGING
Type: Superconductivity / resistive / permanent / hybrid
Nuclei: (Hydrogen / Phosphorus-31 / Sodium-23)
Static field strength [in Tesla (T)]:
Rate of change of magnetic field (rms): (i.e., dB/dt in T/sec)
RF frequency / Pulse width (in μs)
RF power deposition - whole body specific absorption rate (SAR):
Acoustic noise level in decibels (dB):
Other features (e.g. PET/MRI, iMRI, MR-HIFU, etc.)
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5.
Location where the apparatus is to be installed and used:
Address (with postcode):
Specific Location:
(Please attach installation plan where applicable)
6.
Particulars of Person who will be using the apparatus:
Name
Age
Qualification / Relevant Experience
For Laser Apparatus
(N3 Licence)
Please list in separate row if there are more than one person using the apparatus.
Licence amendment fees of $25 per licence are applicable for the inclusion of this laser apparatus into the N3 user licence.
7.
Quality Assurance Instruments to be used:
8.
Protective equipment to be used:
9.
Supporting documents submitted together with this application
S/N
Documents
Please Tick
(a)
Equipment Brochure / Catalogue / Technical Data sheet
(b)
‡Certificate:
(c)
Site Map on the Location of Installation of Equipment
(d)
‡Documentation
(e)
HSA Device Registration Number:_______________
(f)
Others (Please specify):
US-FDA / Australia-TGA / Japan-MHLW / Health Canada / CE-(93/42/EEC)
showing that the apparatus has been registered with or authorized by HSA
‡
Compulsory for medical apparatus imported (brought in) directly from overseas.
10.
Mode of payment* (Check with your Finance Department before completing this section – Please Tick One Only):
 Payment by GIRO (Your company must have a RPNSD Giro Account)
 Payment by cheque – Cheque Number:
(Please refer to Notes below.)
 Payment by NETS or Credit Cards at NEA Customer Service Counter (Level 2, ENV Building, 40 Scotts Road)
* Notes: Unless specially requested, the invoice and the receipt will be sent to the company address provided at Section
1 above. Cheques should be made payable to “National Environment Agency”. Payment by methods not
specified above is liable to be rejected and will cause processing delay to your application.
You are encouraged to use GIRO for all payments. The GIRO application form and instruction can be found on
the NEA website.
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11.
Other remarks pertaining to this application (if any)
[E.g., (i) previous licence number, (ii) date of commission, (iii) payment details, etc.]
12.
I hereby apply for a licence to have in possession the irradiating apparatus specified above for a period of 3 / 6 / 9 / 12 / 24
months and declare that all the particulars contained in this application are correct and true.
Months
3
6
9
12
24
Fees (no GST)
$ 38.75
$ 77.50
$ 116.25
$ 155
$ 310
(
(
(
(
Please Tick One
)
)
(
)
)
)
(Note: This applicant must be a person who is authorized to represent the organization applying for this licence.)
Name of Applicant
Designation of Applicant
Signature of Applicant
Date
The National Environment Agency (NEA) collects personal information to carry out its various functions and duties under
the National Environment Agency Act (Cap 195) including the implementation of environmental and public health policies
in Singapore and any other related purposes. I hereby consent to NEA’s use of the information provided by me in the
course of any application I have made to the NEA, to facilitate the processing of such application for such purposes. I
hereby further consent to NEA sharing the information in such application with other Government agencies, or nongovernment entities authorised to carry out specific government services, unless prohibited by legislation.
Notes:
1.
A separate application is required for each irradiating apparatus.
2.
It is the responsibility of the applicant, and the licensee, to ensure that medical irradiating apparatus comply with any other
applicable regulatory requirements of other regulatory bodies in Singapore (e.g. the Health Sciences Authority).
3.
The completed application form should be submitted together with catalogues, brochures, technical data and the prescribed
fee to:
Director
Radiation Protection and Nuclear Science Department
National Environment Agency
Environment Building
3rd Storey, Annex Block
40 Scotts Road, Singapore 228231
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