Ref. N1 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 MANUFACTURE, POSSESS FOR SALE OR DEAL IN 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. The completed application form should be submitted together with supporting documents, such as catalogues, brochures and technical data and other relevant documents. 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 (Locally-registered organisation only) Company stamp Name of organisation: Address: Nature of business: Contact person: NRIC / FIN No.: Designation: Contact email: Tel No.: Fax No.: Company Unique Entity Number (UEN): 2. Particulars of the Irradiating Apparatus for which licence is sought (Select the equipment type and fill it into the table) For medical apparatus, 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. Type of Irradiating Apparatus: (A) Microwave Ovens; (B) UV Sunlamps; (D) Industrial Ultrasound Apparatus; (E) Laboratory Ultrasound Apparatus; (G) Therapeutic Ultrasound; (H) Entertainment Lasers; (J) Medical (Surgical, Aesthetic or Cosmetic) Lasers; (K) Other: ________________________________ Type Maker / Manufacturer Model (C) Magnetic Resonance Imaging; (F) Diagnostic Ultrasound; (I) Industrial Lasers; Country of origin With brochure Yes / No Yes / No Yes / No * Please list in separate row if there are more than one model of irradiating apparatus. Version 1.8 / Apr 2015 1 Ref. N1 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 Qualification / Licence Remarks * Please list separately if there are more than one person. 4. If the apparatus needs to be operated and/or energized, please provide the location where the activity is performance * Please list separately if there are more than one location. 5. Details of test equipment, workshop, storage facilities and service personnel (if such testing and maintenance is necessary) Test equipment 6. Name & address of storage / workshop Number of qualified person Supporting documents submitted together with this application S/N Documents Please Tick (a) † (b) Equipment Brochures / Catalogues / Technical Data Sheets (c) ‡Certificates: (d) ‡Documentation (e) ‡HSA (f) Others (Please specify): For new application only, a copy of ACRA certificate or printout US-FDA / Australia-TGA / Japan-MHLW / Health Canada / CE-(93/42/EEC) showing that the product(s) has been registered with or authorized by HSA. Device Registration Number:_______________ † ACRA ‡ 7. certificate/printout is compulsory. Compulsory for medical apparatus. 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 NETS / Credit Cards at NEA Customer Service Counter (Level 2, ENV Building, 40 Scotts Road) Payment by cheque – Cheque Number: * Notes: (Please refer to Notes below.) 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. Version 1.8 / Apr 2015 2 Ref. N1 8. Other remarks pertaining to this application (if any) [E.g., (i) previous licence number, (ii) import & export details, (iii) payment details, etc.] 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 organization applying for the 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 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, Radiation Protection and Nuclear Science Department 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 Radiation Protection and Nuclear Science Department National Environment Agency Environment Building 3rd Storey, Annex Block 40 Scotts Road, Singapore 228231 Version 1.8 / Apr 2015 3