IR1 - Licence to manufacture, possess for sale or deal in irradiating apparatus or radioactive materials

Who needs the IR1 - Licence to manufacture, possess for sale or deal in irradiating apparatus or radioactive materials

This licence applies to Singapore businesses registered under the following SSIC industry codes:

• Required to operate26602 — Manufacture/repair of irradiation and electromedical equipment and instruments

  Includes: 26602 Manufacture/repair of irradiation and electromedical equipment and instruments

• Required to operate20293 — Manufacture of water treatment, waste treatment and oilfield chemicals

  Includes: 20293 Manufacture of water treatment, waste treatment and oilfield chemicals

Items the applicant typically needs ready before submitting:

• Irradiating apparatus / radioactive material information
• Brochures, catalogues, data sheets, etc. showing the technical specifications of the apparatus or radioactive material
• Floor plan / Site layout
• For storage or manufacture of radioactive materials, please provide the floor plan and layout of the storage / installation site.
• Radiation Protection Plan
• For storage or manufacture of radioactive materials, please provide Radiation Protection Plan (RPP) and relevant Standard Operating Procedures (SOP). These should include waste management, disposal/decommissioning plan and emergency response plans, where applicable.
• Disposal plan
• For radioactive materials, please provide the disposal plan and where applicable, official document(s) stating that the overseas manufacturer / supplier can and will accept the return of disused sources for proper disposal.
• Acknowledgement for acceptance of disused sources
• For radioactive materials, please provide the official document to your customers stating that your organisation will accept the return of disused sources for repatriation to country of origin.
• HSA authorisation for medical devices/therapeutic products
• For applications including medical devices or therapeutic products, please provide the HSA Medical Device Registration or proof of exemption from registration.