Regulatory Requirements
In this page, you will find information for a new or existing cord blood banking service licensee on the cord blood banking 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 cord blood banking 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 the legislative requirements may be found in the Summary of Requirements.
When is a Cord Blood Banking Service licence needed?
You will require a Cord Blood Banking Service licence if you:
a. Handle, process, store and distribute cord blood intended for clinical use in the same or another individual.
You will not require a Cord Blood Banking Service licence if you:
a. Are a HCSA licensee and only assists the Cord Blood Banking
For the legal definition of a Cord Blood Banking Service, please refer to the First Schedule of the Act
Note: Although a Cord Blood Banking 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 for Cord Blood Banking Service is permanent premises. There are no Specified Services offered under the Cord Blood Banking Service.
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 practicing certificate
c. Be registered as a specialist in haematology;
d. Have at least 5 years
of work experience in -
- Haematopoietic stem cell transplant;
- Transfusion medicine, provided that the working experience relates to the assessment, screening and evaluation of donors of cord blood;
- Blood banking;
- Cord blood banking; or
- Any other activity relating to the provision of a cord blood banking service approved by the Director General
For further details on the qualifications, skills and competencies of a CGO, please refer to Section 4 of the Cord Blood Banking 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. 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.