Many of the irradiating apparatus and radioactive materials will only be allowed to be imported or exported after the relevant supporting licences have been obtained as detailed below.
Controlled Irradiating Apparatus
1. Dealer Licence (L1 or N1)
A valid dealer licence (L1 or N1) is required before the import or export of an irradiating apparatus for the purpose to manufacture or to deal through sale, distribution or rent/loan.
A licence application for a dealer licence should be submitted at least 3 weeks prior to shipment date, together with relevant documents* via the GoBusiness Licensing Portal: https://www.gobusiness.gov.sg/licences. Please note the additional requirements+ for microwave ovens and medical radiation equipment.
For importers or exporters with an existing dealer licence who wish to import or export a controlled irradiating apparatus not listed in their licence, a licence amendment application should be submitted together with the relevant documents* via the GoBusiness Licensing Portal: https://www.gobusiness.gov.sg/licences.
You may refer to the page on Guidelines for Licence Application for more information.
- Microwave ovens
Microwave ovens for local sale will need to comply with Regulation 25(5) of the Radiation Protection (Non-Ionising Radiation) Regulations. In addition, the Certification Body test report with the radiofrequency and X-ray radiation leakage values must be submitted before it will be approved for local sale. (For more details, please contact NEA officers before submission of the licence amendment request.)
- Medical radiation equipment
Please provide the following additional documents:
- Regulatory approval from at least one of the 5 reference agencies (US Food and Drug Administration, Health Canada, Australian Therapeutic Goods Administration, Japan Ministry of Health, CE marking)
- Product registration approval and/or acknowledgment email from the Medical Device Branch of the Health Sciences Authority (MDB-HSA)
- Other types of MDB-HSA special authorization or acknowledgement
The application for the HSA Special Access Route (SAR) approval and the application for dealer licence amendment should be submitted simultaneously to HSA and NEA respectively. More details on the HSA SAR and product registration can be found on the HSA website: http://www.hsa.gov.sg/medical-devices/registration.
2. Possession Licence (L3 or N2)
A possession licence (L3 or N2) is required to import or export an irradiating apparatus if it is imported or exported by the end user for the purpose of possession for use. A possession licence is needed for each unit of irradiating apparatus.
The licence application for a possession licence should be submitted with the relevant documents* via GoBusiness Licensing Portal: https://www.gobusiness.gov.sg/licences. For export of irradiating apparatus, the irradiating apparatus should be licensed under an appropriate possession licence before export. You may refer to the page on Guidelines for Licence Application for more information.
- Equipment Brochure
- Equipment Manual
- Compliance Certificates (CE-Certificate or other safety certificate, or/and laboratory report)
- Data Sheet (if available)
The import and export of radioactive materials must be supported by a valid dealer (L2) or possession (L4) licence, and where applicable, the transport licence (L6A) and user licence (L6). You may refer to the page on Guidelines for Licence Application for more information.
Importers, exporters and declaring agents should contact NEA (NEA_RPNSD_TradeNet@nea.gov.sg) to seek clarifications on licensing requirements, safety measures required and repatriation conditions before proceeding to initiate any import or export involving radioactive materials or ores.