Also note that the requirements stipulated in the Health by 6Y0V811

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Centre for Radiation Protection and Nuclear Science
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 MANUFACTURE, POSSESS FOR SALE
              OR DEAL IN NON-IONISING RADIATION IRRADIATING APPARATUS

                  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.


1.     Particulars of the Organisation (Local-registered organisation only)

        Name of organisation:                                                                           Company stamp

        Address:




        Nature of business:

        Contact person:                                                Designation:

        NRIC / FIN No.:                                                Contact email:

        Tel No.:                                                       Fax No.:

       Company Unique Entity Number (UEN):




2.     Particulars of the Irradiating Apparatus for which licence is sought

       For medical apparatus, please submit certificates/document 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.

         *Type: (Please select one)

          Microwave Ovens                          UV Sunlamps                               Magnetic Resonance Imaging

          Industrial Ultrasound                    Therapeutic Ultrasound                    Diagnostic Ultrasound

          Industrial Lasers                        Entertainment Lasers                      Medical Lasers

          Others Lasers                            Other:

         Maker / Manufacturer:

         Country of origin:

         Model:

       * Please list separately if there are more than one irradiating apparatus.


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3.     If your company need to energize the apparatus for demonstration, maintenance or testing, please provide the particulars of
       the people* who will be involved in this operation

           Name:

           Age:

           Qualifications:

      * Please list separately if there are more than one person.


4.     State the location* where the apparatus is to be operated for demonstration / maintenance / testing




      * Please list separately if there are more than one location.


5.     Details of test equipment, workshop, storage facilities and service personnel

           Test equipment:



           Name & address of storage / workshop:



           Number of qualified service personnel:




6.     Supporting documents submitted together with this application

           S/N     Documents                                                                                          Please Tick

           (a)     For new application only, a copy of ACRA† certificate or printout

           (b)     Equipment Brochures / Catalogues / Technical Data Sheets

           (c)     Certificates‡: US-FDA / Australia-TGA / Japan-MHLW / Health Canada / CE-(93/42/EEC)

           (d)     Others (Please specify):
       †
           ACRA certificate/printout is compulsory.
       ‡
           Compulsory for Medical Devices.


7.     Mode of payment* (Check with your Finance Department before completing this section – Please Tick One Only)


            Payment by GIRO (Your company must have a CRPNS Giro Account)

            Payment by cheque (Please refer to Notes below.)

            Payment by NETS / 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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8.       Other remarks pertaining to this application (if any)




9.       I hereby apply for a licence to *manufacture / possess for sale / deal in 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)                    $ 55             $ 105             $ 160                 $ 210            $ 420
               Please Tick One              (          )         (       )         (       )             (        )       (        )
         * If irradiating apparatus component parts are to be imported separately in different consignments and later assembled
         together as complete units, then this will constitute manufacturing. If no manufacturing is to be undertaken, please delete the
         word manufacture in Section 9.

          (Note: The applicant must be a person who is authorized to represent the company.)




                             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 non-government entities
         authorised to carry out specific government services, unless prohibited by legislation.


Notes:

1.       The attention of the applicant is drawn to Section 6(2) of the Radiation Protection Act 2007 which requires that notice of
         every sale of irradiating apparatus be given to the Director-General of Environmental Protection, National Environment
         Agency. The details of the apparatus as specified in Section 2 and the serial number are to be submitted to the Director,
         Centre for Radiation Protection and Nuclear Science together with the name and address of the person to whom it was sold.

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 catalogue, brochures, technical data, safety related
         certificates and the prescribed fee to:

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

4.       Please call us at Tel. 6731 9544 if you need any assistance in filling up this form.




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