Irradiating Apparatus Information - Technical specifications, brochures etc.
HSA Medical Device Registration - For applications including medical devices, please attach HSA Medical Device Registration or proof of exemption from registration
Other supporting documents - Other relevant supporting documents
1. Do I need to apply for this licence?
This licence is required if you intend to manufacture, possess for sale, sell or deal in irradiating apparatus. Irradiating apparatus include, but are not limited to:
X-ray equipment (medical or non-medical)
X-ray equipment (fixed or portable)
Charged particle accelerator
Linear accelerator (LINAC)
OPG or PA
Scanning electron microscope
2. What conditions do I need to fulfil?
1) The company must have a valid UEN.
2) The company must comply with the Radiation Protection Act and its subsidiary Regulations, in particular the Radiation Protection (Ionising Radiation) Regulations.
3. What supporting documents do I need to submit?
1) Technical specifications / brochures
2) If a medical device is to be imported for local sale, HSA registration / authorisation must be obtained.
4. How soon can my application be processed?
Complete applications with the necessary supporting documents will typically be processed within 10 working days upon reception of the submission. Licence applications that require pre-licence inspections and/or licence applicants who are instructed to sit for a qualifying test may require a longer period of time (4 – 8 weeks or more).
5. How long is it valid for?
The licence is valid for 3, 6, 9, 12 or 24 months.
6. How do I obtain a license?
In order to obtain a license, the following steps will be carried out:
The client provides required documents for preliminary review assessment
If structure and officers of a proposed company are confirmed, kimbocorp proceeds with incorporation of a Singapore company
Upon receipt of corporate documents, kimbocorp proceeds with bank account opening
If applied for kimbocorp services it is possible to receive a professional assistance with preparation of business plan, relevant policies and manuals (based on factual information provided by the client)
kimbocorp proceeds with lodging a license application to NEA
Upon receipt of any comments from NEA, kimbocorp either replies, or amends the application accordingly until the final decision from NEA.
7. I need more details about import and export licence. Where may I find it?
In most cases, import and export licences, i.e. L7A/B, L8A/B and N4A/B, are to be applied through the TradeNet system by freight companies which handle the transportation of cargoes from one Country/Region to another. Before the applications for import and export licences are submitted through TradeNet, L1 and L2 licensee should ensure that their dealer licences, i.e. L1 or L2 are valid and have been updated to include the irradiating apparatus or radioactive material, and that they have obtained the relevant possession licence if the apparatus is for use at their premises.
For more information on the items under import and export control, please refer to the following links:
8. What other approval is needed in order to supply or possess a medical irradiating apparatus?
Medical devices are controlled under the Health Products Act administered by the Health Sciences Authority (HSA). Radiation emitting medical equipment are required to be registered and/or authorised by HSA before the equipment can be supplied in Singapore.
Your company should check with MDB/HSA (www.hsa.gov.sg) concurrently to find out the relevant requirements when you are preparing for the radiation licence application.
Certain types of radiation emitting equipment may only be possessed by medical and/or healthcare establishments, and may only be used by registered medical and healthcare professionals at places registered with the Ministry of Health.
9. Where can I find more radiation regulatory and licensing information?
You may refer to the radiation safety webpage on the NEA website: www.nea.gov.sg > Our Services > Radiation Safety
Build and register a business in Singapore with ease
kimbocorp provides everything you need to maintain a thriving business in Singapore, right in your browser.
Facilitation of a physical bank account to be registered in Singapore under "Your company name" Pte Ltd
Unlimited number of signed agreements with investors, customers, suppliers etc., required in order to qualify for the physical bank account
And everything from kimbocorp exempt
Building companies made easy
Built in Singapore by cost-conscious professionals-turn-business owners. There is no need to pay hefty upfront fees like our competitors. Just tell us your project or business and build it with us remotely using your browser.
"More than a service provider"
"Huan, director of kimbocorp, has helped us to obtain government funding that effectively transforms our business and brand outlook. Today we have a spanking new site, ability to engage with customers and fulfill them remotely. I will continue to go back to Huan and kimbocorp for more capabilities moving forward."
"Kimbocorp provided business license and banking relationship within days. The process was swift and predictable and I got what I wanted. We are trying to work with them on more intangible assets and business capabilities."