N1 - Licence to manufacture, possess for sale or deal in non-ionising radiation irradiating apparatus
The N1 Licence to manufacture, possess for sale or deal in non-ionising radiation irradiating apparatus is issued by the National Environment Agency (NEA) in Singapore. It is required for businesses involved with such apparatus, with a validity of 3 to 24 months and a processing time of 20 working days upon complete submission.
- Validity
- 3,6,9, 12 or 24 months
- Processing time
- 20 working days (excluding inspections), upon receipt of complete and accurate submission of all required documents
- Issuing authority
- NATIONAL ENVIRONMENT AGENCY (NEA)
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Who needs the N1 - Licence to manufacture, possess for sale or deal in non-ionising radiation irradiating apparatus
This licence applies to Singapore businesses registered under the following SSIC industry codes:
What's involved in getting the N1 - Licence to manufacture, possess for sale or deal in non-ionising radiation irradiating apparatus
The scope of the application — what must be in place, how the agency reviews, and where applications typically stall.
To apply for the N1 Licence, follow these steps:
Application Channel
The application is submitted via the GoBusiness Dashboard.
Prerequisites
Before applying, ensure you have the following documents ready:
- Irradiating apparatus information
- Brochures, catalogues, data sheets, etc. showing the technical specifications of the apparatus
- HSA authorisation (if applicable for medical devices)
- For applications including medical devices, provide HSA Medical Device Registration or proof of exemption from registration
- Equipment certificates for devices used on humans without HSA authorisation
- Certificate of equipment to be licensed issued by one of the following organisations:
- US-FDA
- Australia-TGA
- Japan-MHLW
- Health Canada
- CE-(93/42/EEC)
Document Preparation
Gather all required documents and ensure they are complete and accurate to avoid delays.
Submission
Once your documents are ready, submit your application through the GoBusiness Dashboard. The NEA will process your application within 20 working days, excluding any inspections, upon receipt of all required documents.
Required documents and prerequisites
Items the applicant typically needs ready before submitting:
- Irradiating apparatus information
- Brochures, catalogues, data sheets, etc. showing the technical specifications of the apparatus
- HSA authorisation (For medical devices)
- For applications including medical devices, please provide HSA Medical Device Registration or proof of exemption from registration.
- Equipment certificates (For devices used on human without HSA authorisation)
- Certificate of equipment to be licensed issued by one of the following organisations: US-FDA / Australia-TGA / Japan-MHLW / Health Canada / CE-(93/42/EEC)
N1 - Licence to manufacture, possess for sale or deal in non-ionising radiation irradiating apparatus FAQ
Can a foreign-owned company apply for the N1 Licence?
Yes, foreign-owned companies can apply for the N1 Licence in Singapore, provided they meet all the necessary prerequisites and documentation requirements.
What happens if I operate without the N1 Licence?
Operating without the N1 Licence may result in penalties, including fines or legal action by the National Environment Agency (NEA). It is essential to obtain the licence to comply with Singapore's regulations.
Is this licence required if I only sell non-ionising radiation apparatus online?
Yes, the N1 Licence is required regardless of whether the sales occur online or in a physical location. Compliance with licensing regulations is mandatory for all sales of non-ionising radiation apparatus.
Does this apply to home-based businesses?
Yes, home-based businesses that manufacture, possess for sale, or deal in non-ionising radiation irradiating apparatus must obtain the N1 Licence to operate legally in Singapore.
How long is the validity of the N1 Licence?
The N1 Licence can be valid for 3, 6, 9, 12, or 24 months, depending on the specific terms set during the application process.
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