Regulatory Requirements

In this page, you will find information for a new or existing outpatient renal dialysis service licensee on the outpatient renal dialysis 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, an outpatient renal dialysis 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 HoldersA licensee who offers the collaborative prescribing specified service, will also be required to comply with the Collaborative Prescribing RegulationsMore information on the legislative requirements may be found in the Summary of Requirements.

When is an Outpatient Renal Dialysis Service licence needed?

You will require an Outpatient Renal Dialysis Service licence if you:

  1. Provide haemodialysis or peritoneal dialysis support * only to outpatients.
  2. Provide any healthcare service that is incidental to the provision of haemodialysis or peritoneal dialysis support.

 

You will not require an Outpatient Renal Dialysis Service licence if you:

  1. Provide peritoneal dialysis support* under your Outpatient Medical Service licence.

 

*“Peritoneal dialysis support” means both of the following services:

  1. teaching a patient to perform peritoneal dialysis in a home setting, for himself or herself; and
  2. providing medical or nursing care and treatment for a peritoneal dialysis patient who develops or may develop complications or requires assistance with the performance of peritoneal dialysis.

 

For the legal definition of an Outpatient Renal Dialysis Service, please refer to the First Schedule of the Act.

Applicable Specified Services and Mode of Service Delivery

Mode of Service Delivery
Permanent PremisesTemporary Premises ConveyanceRemote
Licensable Healthcare ServiceOutpatient Renal Dialysis Service     *
Specified ServicesCollaborative Prescribing Service     *
High-dependency Haemodialysis (for licensees offering haemodialysis only)     

*Remote provision of Outpatient Renal Dialysis Service can only be offered in conjunction with another mode of service delivery (e.g. permanent premises).

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 the Singapore Medical Council (SMC) and hold a valid practising certificate

c. Be registered as a specialist with SMC in the branch of renal medicine

d. Has full-time work experience as a medical practitioner for at least 2 continuous years treating patients in the provision of either

i. A renal dialysis service provided in a private hospital or medical clinic licensed under the Private Hospitals and Medical Clinics Act;

ii. An Outpatient Renal Dialysis Service licensed under HCSA; or

iii. A renal dialysis service as part of an Acute Hospital Service or Community Hospital Service licensed under HCSA.

 

For further details on the qualifications, skills and competencies of a CGO, please refer to Regulation 8 of the Outpatient Renal Dialysis 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.

Licence Fee

The applicable licence fee for Outpatient Renal Dialysis Service is $850 for each standalone mode of service delivery (MOSD). A MOSD fee bundle might apply if you provide Outpatient Renal Dialysis Service via multiple MOSDs, e.g. permanent premises alongside temporary premises and remote.

Please see the Table below for more details of the exact fee applicable.

S/N List of Possible Combinations Eligibility for MOSD bundle Licence Fee
1 1 MOSD only:
  • Brick-and-mortar clinic only (Permanent Premises only )
  • Peritoneal dialysis with home visit only (Temporary Premises only)
Not Applicable $850
2 Brick-and-mortar clinic (one clinic) + Peritoneal dialysis with home visit
(Permanent Premises + Temporary Premises)
Yes $850
3 Brick-and-mortar clinic (one clinic) + Peritoneal dialysis with home visit + Teleconsultation incidental to renal dialysis service
(Permanent Premises + Temporary Premises + Remote*)
Yes $850
4 Peritoneal dialysis with home visit + Teleconsultation incidental to renal dialysis service
(Temporary Premises + Remote*)
Yes $850

*Remote provision of Outpatient Dental Service can only be offered in conjunction with another mode of service delivery (e.g., permanent premises).

 

If you provide any Specified Services (SS), you will have to pay an SS approval fee in addition to the licence fee. Please refer to the Table below for details of the exact fee payable


Licence Fee for Outpatient Renal Dialysis Service*SS Approval Fee Total Fee
(A) (B) (A) + (B)
Outpatient Renal Dialysis Service + 1 SS $850$900 $1,750
Outpatient Renal Dialysis Service + 2 SSes $850$1,700 $2,550

*The $850 licence fee assumes that you only provide outpatient medical service via one permanent premises or one of the MOSD bundle combinations.