Regulatory Requirements

In this page, you will find information on the nuclear medicine service regulations and licence conditions, its applicable specified services and the allowable modes of service delivery, requirements to be a clinical governance officer, and licence fees. Please note that in addition to the requirements set out here, a nuclear medicine service licensee is also required to comply with the Healthcare Services Act 2020, the General Regulations, Advertisement Regulations, Fees Regulations and the Code of Practice for Key Office Holders. More information on these general requirements may be found in the Summary of Requirements .

Please note that in addition to the requirements set out here, a nuclear medicine service licensee is also required to comply with the Healthcare Services Act 2020, the General RegulationsAdvertisement RegulationsFees Regulations and the Code of Practice for Key Office Holders. More information on these general requirements may be found in the Summary of Requirements.

When is a Nuclear Medicine Service licence need?

You will require a Nuclear Medicine Service licence if you:

a. Administer radiopharmaceuticals to patients for therapeutic or diagnostic purposes*

*Diagnostic purposes include the use of an imaging modality (e.g. PET-CT, SPECT) and/or assay (e.g. C-14 urea breath test, Tc-99m GFR test) after the administration of radiopharmaceuticals.

 

You will not require a Nuclear Medicine Service licence if you:

a. Hold a Clinical Laboratory Service licence and test specimens using radioactive reagents (see Clinical Laboratory Service).

 

For the legal definition of a Nuclear Medicine Service, please refer to the First Schedule of the Act.

Note: Although a Nuclear Medicine Service licence may not be applicable for your service, your service may still be subject to regulation as another Licensable Healthcare Service under the Healthcare Services Act (HCSA). Please refer to the list of Licensable Healthcare Services for more information.

Applicable Specified Services and Mode of Service Delivery

The only allowable Mode of Service Delivery (MOSD) for Nuclear Medicine Service is permanent premises.

Nuclear Medicine Imaging, which includes all imaging modalities such as PET-CT, SPECT and PET-MRI, is a Specified Service under the Nuclear Medicine Service. Other nuclear medicine services include Nuclear Medicine Therapy and/or Nuclear Medicine in vivo Assay. The allowable MOSD for Nuclear Medicine Imaging, Nuclear Medicine Therapy and/or Nuclear Medicine in vivo Assay is permanent premises.

Note: There is no need to seek approval for each Nuclear Medicine Imaging modalities, Nuclear Medicine Therapy and/or Nuclear Medicine in vivo Assay. However, licensees are to notify MOH before the provision of such services.

Requirements to be a Clinical Governance Officer

An individual must be in good standing and fulfil all of the criteria below to be appointed as a Clinical Governance Officer (CGO).

 

1. For an individual to fulfil the requirements to be a CGO, he or she must:

a. Reside in Singapore during his or her appointment as a CGO

b. Be a fully registered medical practitioner with SMC and hold a valid practising certificate

c. Be registered as a specialist in nuclear medicine, with at least 5 years of work experience in providing the nuclear medicine service

 

For the purposes of cardiac nuclear medicine imaging, the individual may, instead of fulfilling criteria 1c to be registered as a specialist in nuclear medicine with at least 5 years of work experience, fulfil the following criteria:

d. Be registered as a specialist in cardiology

e. Hold a certification in nuclear cardiology from the Certification Board of Nuclear Cardiology (or equivalent)

f. Have at least 5 years of work experience in providing the nuclear medicine imaging service, after obtaining the certification in nuclear cardiology.

 

For further details on the qualifications, skills and competencies of a CGO, please refer to Section 7 of the Nuclear Medicine Service Regulations

 

2. For an individual to fulfil the suitability qualifications to be a CGO, he or she must not:

a. Have any of the following convictions, unless it is a spent conviction:

i. An offence involving fraud or dishonesty;

ii. An offence under the HCSA, the PHMCA or any applicable Acts listed in the Annex A of the Code of Practice;

iii. An offence specified in the Third Schedule to the Registration of Criminals Act; or

iv. Any other offence involving abuse, ill treatment, assault, or physical violence

b. Have a pending charge for an offence under 2a(iv)

c. Be an undischarged bankrupt

d. Have had his or her healthcare professional registration(s) under MOH cancelled, removed, or suspended

e. Have been a director or manager of a healthcare services provider that had its registration or licence suspended, cancelled, or revoked

f. Have had his or her accreditation or approval to participate in MOH-administered public schemes revoked or suspended

g. Lack capacity within the meaning of the Mental Capacity Act 2008.

 

For further details on the suitability requirements for a Key Office Holder, please refer to the Code of Practice.