Introduction
Medical diagnostic imaging ultrasound and therapeutic ultrasound apparatus, sunlamps and high power lasers are controlled irradiating apparatus under the Radiation Protection Act 2007. A licence from the National Environment Agency (NEA) is required to import, export, keep, possess, use, manufacture or otherwise produce, sell, or deal with these apparatus. Only licensed workers are allowed to operate high power lasers1 and only registered medical practitioners are allowed to operate class 4 high power lasers and high intensity focused ultrasound (HIFU) apparatus on humans at premises approved by MOH for the provision of licensable healthcare services. Suppliers and dealers of beauty and medical apparatus are required to be mindful of these requirements, and should not supply class 4 high power lasers and HIFU apparatus to people who are not registered medical practitioners, e.g. beauticians.
In addition, under the Radiation Protection Act 2007, no person may dispose of any controlled irradiating apparatus without the approval in writing of the Director-General of Environmental Protection.
Frequently Asked Questions
1. I suspect that I have an irradiating apparatus at my premises without a valid licence. What should I do?
You should stop using the apparatus immediately and keep it in a safe manner at your premises. Do not throw away the apparatus.
If you are not a licensee under Healthcare Services Act (HCSA) and Private Hospitals and Medical Clinics Act (PHMCA), contact the Radiation Protection and Nuclear Science Group (RPNSG) of NEA via the online feedback form or myENV app with the following information:
a. Make/model/serial number of the apparatus;
b. Where/whom was the apparatus purchased from; and
c. Relevant import/purchase/usage records of the apparatus.
NEA officers in RPNSG will advise you in writing on the appropriate steps to take.
If you are a licensee under HCSA and PHMCA, you should immediately apply for the N1 and/or N2 licence via the GoBusiness portal (GoBusiness Singapore) using Singpass for business user. More information on the licence application can be found on the webpage NEA | Guidelines for Licence Application and Annual Payment.
For any enquiries on the licence requirement or application process, please send to NEA_RPNSD_Licence@nea.gov.sg.
2. What are the penalties for offences committed?
Any person who imports, exports, keeps, possesses, uses, manufactures or otherwise produces, or sells, deals with or otherwise deals in any irradiating apparatus without a licence can be charged in court and be liable on conviction to a fine up to $100,000 or to imprisonment for a term up to 5 years or to both.
Any person who fails to give notice of the sale/purchase of any irradiating apparatus to the Director-General or disposes of any irradiating apparatus without approval from the Director-General of Environmental Protection can be charged in court and be liable on conviction to a fine up to $50,000 or to imprisonment for a term up to 12 months or to both.
Please note that HCSA and PHMCA licensees found in possession of controlled irradiating apparatus without a valid NEA licence during MOH inspections may be subjected to non-compliance action.
3. What are the licences required for controlled irradiating apparatus under the Radiation Protection Act 2007?
The licences listed below are required:
- N1 licence: Licence to manufacture or deal with
- N2 licence: Licence to keep, or possess, for use
- N3 licence: Licence to use high power lasers2
- N4A licence: Licence to import
- N4B licence: Licence to export
Common apparatus type (The following is a non-exhaustive list of controlled non-ionising irradiating apparatus) | Licence required |
N1, N4A | N2, N4B | N3 |
Fetal heart monitoring doppler non-imaging ultrasound apparatus | X | | |
Ultraviolet sunlamps | X | | |
HIFU | X | X | |
Magnetic resonance imaging apparatus | X | X | |
Medical diagnostic imaging ultrasound apparatus | X | X | |
Medical therapeutic ultrasound apparatus | X | X | |
High power1 lasers | X | X | X |
Advisory and multilingual pamphlet
Advisory for High Intensity Focused Ultrasound Apparatus can be downloadable here.
A pamphlet in English, Mandarin, Malay and Tamil can be downloadable here.
Information on other beauty related equipment
• IPL devices
• Ultraviolet (UV) Sun Tanning Beds
• High Intensity Focused Ultrasound apparatus
1 As stipulated in the Radiation Protection (Non-ionising Radiation) Regulations, high power lasers are class 3b and 4 lasers
2 An N3 licence is not required for registered medical practitioners or dentists if they have obtained the consent of both of the following persons to use a medical laser at an approved premises for the provision of the licensable healthcare service:
- the individual in charge of that approved premises;
- the licensee of the N2 licence granted in respect of that medical laser.