Licence or Approval Type | Information Required/Supporting Documents | Application/Annual Fee (per application or licence, unless otherwise stated) |
IR1, N1 | - Details of apparatus and radioactive materials such as
- [For both apparatus and radioactive materials] Name of manufacturer, country of manufacture and model
- [For apparatus only] Maximum voltage, maximum current
- [For radioactive materials only] Radionuclide, maximum radioactivity, form and nature of substance
- For radioactive materials only,
- Official document from your overseas supplier stating that they will accept the return of disused sources for proper disposal
- Official document to your customers stating that your organisation will accept the return of disused sources for proper disposal
- [For manufacturing of radioactive materials only] Radiation Protection Plan; information on radioactive waste generation and disposal/decommissioning plan
- Address of storage location (for IR1)/operation location (for N1)
- Brochures, catalogues or data sheets showing the technical specifications of the apparatus or radioactive materials
- [For laser apparatus] Manual showing laser safety instructions
- [For apparatus or radioactive materials to be used on human beings] Registration approval or authorisation from the Health Sciences Authority (HSA) for medical devices and/or therapeutic products intended for local sale
- [N1 licence][Consultation\Clarification on the regulatory requirements] Please contact RPNSG via NEA's online feedback form or myENV app before submitting any licence application. Please provide the following documents/ information for review:
- Medical devices (e.g. MRI, Diagnostic Imaging Ultrasound, non-cosmetic medical lasers etc.) [Documents: Equipment brochure/manual; HSA’s device registration number; HSA’s approval for GN-26/GN-27/GN-29 application, OR overseas medical regulator’s approval (US-FDA; Canada health; Australia TGA; Japan MHLW; or CE[93/42/EEC])] [IEC 60825-1 report: For laser devices classified as Class 1 laser products]
- Cosmetic medical lasers and therapeutic ultrasound [Documents: Equipment brochure/manual; HSA’s clearance/ exemption from Health Products (Medical Devices) Regulations, OR overseas medical regulator’s approval, OR other appropriate certificates (IEC-60601-1 test report, K-FDA free sale certificate, IEC 60335-1 and IEC 60335-2-23)] [IEC 60825-1 report: For laser devices classified as Class 1 laser products]
- Non-medical lasers, industrial ultrasound and ultraviolet sunlamps [Documents: Equipment brochure/manual] [IEC 60825-1 report: For laser devices classified as Class 1 laser products]
- Microwave oven [Documents: Equipment brochure/manual; Radiation leakage lab report; IEC 60335-2-25 (for household microwave ovens) or IEC 60335-2-90 (for commercial microwave ovens)]
| For IR1:
- $210 for first year
- $210 annual fee for subsequent years
For N1:
- $52.50 (3 months)
- $105 (6 months)
- $157.50 (9 months)
- $210 (1 year)
- $420 (2 years)
|
IR2 | - Particulars of supplier (name, address, IR1 licence number if local supplier)
- Details of apparatus and radioactive materials such as
- [For both apparatus and radioactive materials] Name of manufacturer, country of manufacture, model and serial number (note: If the serial number cannot be confirmed at time of application, applicant may indicate “TBC”)
- [For apparatus only] Maximum voltage, maximum current
- [For radioactive materials only] Radionuclide, maximum radioactivity, date as at stated radioactivity, form & nature of substance
- Storage location address
- Brochures, catalogues or data sheets showing the technical specifications of the apparatus or radioactive materials
- Floor plan showing position of apparatus or radioactive materials within controlled area and areas surrounding the controlled area
- Radiation Protection Plan
- [For accelerators and proton beam only] Decommissioning plan
- [For radioactive materials only] Official document from your supplier stating that they will accept the return of disused sources for proper disposal (if applicable)
- The approximate date of commissioning of the apparatus or radioactive materials. This will facilitate the arrangement of the pre-licensing inspection
- [For apparatus or radioactive materials to be used on human beings] Registration approval or authorisation from the Health Sciences Authority (HSA) for medical devices and/or therapeutic products intended for use
Note:
- [For apparatus only] You may apply for the IR2 licence once the sales/purchase is confirmed. The pre-licensing inspection can only be conducted after installation and the apparatus should not be energised before the inspection unless authorisation is given.
- [For radioactive materials only] An authorisation letter will be issued to the applicant to temporarily possess the radioactive materials to facilitate the conduct of the pre-licensing inspection for IR2 licence.
| For first year: - $155 per irradiating apparatus
- $155 for at least one (a) irradiating apparatus containing radioactive material, or (b) radioactive material
For subsequent years: - $155 annual fee per irradiating apparatus
- $155 annual fee for at least one (a) irradiating apparatus containing radioactive material, or (b) radioactive material
|
N2 | - Particulars of supplier (name, address, N1 licence number if local supplier)
- Details of apparatus such as name of manufacturer, make/model and serial number
- Address of storage location
- Brochures, catalogues or data sheets showing the technical specifications of the apparatus
- [For laser apparatus] Manual showing laser safety instructions
- [For MRI apparatus] Detailed SOP, QA checklist, site map of location of use with 5-G lines indicated, quench exhaust line and photo of nameplate
- [For apparatus to be used on human beings] Registration approval or authorisation from the Health Sciences Authority (HSA) for medical devices
- N2 licence][ [Consultation\Clarification on the regulatory requirements] Please contact RPNSG via NEA's online feedback form or myENV app before submitting any licence application. Please provide the following documents/ information for review:
- Medical devices (e.g. MRI, Diagnostic Imaging Ultrasound, non-cosmetic medical lasers etc.) [Documents: Equipment brochure/manual; HSA’s device registration number; HSA’s approval for GN-26/GN-27/GN-29 application, OR overseas medical regulator’s approval (US-FDA; Canada health; Australia TGA; Japan MHLW; or CE[93/42/EEC])] [HCSA licence/ documentation proof of application][IEC 60825-1 report: For laser devices classified as Class 1 laser products] [Apparatus location of use]
- Cosmetic medical lasers and therapeutic ultrasound [Documents: Equipment brochure/manual; HSA’s clearance/ exemption from Health Products (Medical Devices) Regulations, OR overseas medical regulator’s approval, OR other appropriate certificates (IEC-60601-1 test report, K-FDA free sale certificate, IEC 60335-1 and IEC 60335-2-23)] [IEC 60825-1 report: For laser devices classified as Class 1 laser products] [Apparatus location of use]
- Non-medical lasers and industrial ultrasound [Documents: Equipment brochure/manual] [IEC 60825-1 report: For laser devices classified as Class 1 laser products] [Apparatus location of use]
| - $155 per apparatus for first year
- $65 annual fee per apparatus for subsequent years
|
R1 | - Medical Certificate Form for R1 Applications (MC-1)
- Documentary proof of relevant training/qualifications
- [For medical doctors and dentists] Singapore Medical Council/Singapore Dental Council registration number
- [For veterinarians] Animal and Veterinary Service licence number
- [For medical diagnostic radiographers and radiation therapists] In-principle approval for registration or registration certificate with the Allied Health Professional Council (AHPC)
| - $105 for first year
- $50 annual fee for subsequent years
|
N3 | - Medical Certificate Form for N3 Applications (MC-2)
- Documentary proof of relevant training/qualifications (e.g. Basic Laser Safety Course certificate)
| - $26.25 (3 months)
- $52.50 (6 months)
- $78.75 (9 months)
- $105 (1 year)
- $210 (2 years)
|
IR3 | - Transport Emergency Response Plan (TERP template)
- To facilitate the application process, a draft copy of the TERP may be sent to NEA (via NEA’s online feedback form) for preliminary review first before submitting the application via GoBusiness Singapore Portal.
| - $155 for first year
- $155 annual fee for subsequent years
|
Approval to accumulate radioactive waste | - Type of radionuclide
- Quantity and its respective activities
- Radiation Protection Plan
- Storage location
- Floor plan
- Emergency preparedness and response plan
| $600 per annum |
Approval to transport radioactive waste | - Type of radionuclide
- Quantity and its respective activities
- Radiation Protection Plan
- Destination of transport
- Transport plan
- Emergency preparedness and response plan
| $600 |