Cord Blood Banking Service

Regulatory requirements

When is a Cord Blood Banking Service licence needed?

You will require a Cord Blood Banking Service licence if you perform any of the following purposes:

• 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 perform any of the following purposes:

• 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.

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:

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

   • Be a fully registered medical practitioner with the Singapore Medical Council (SMC) and hold a valid practising certificate

   • Be registered as a specialist in haematology;

   • 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

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

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

     • An offence involving fraud or dishonesty;

     • Offence under the HCSA, the PHMCA or any applicable Acts listed in the Annex A of the Code of Practice [PDF, 439KB];

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

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

   • Have a pending charge for an offence involving abuse, ill treatment, assault, or physical violence

   • Be an undischarged bankrupt

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

   • Have been a director or manager of a healthcare service provider that had its registration or licence suspended, cancelled, or revoked

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

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

For further details on the qualifications, skills and competencies of a CGO, please refer to Section 4 of the Cord Blood Banking Service Regulations.

For further details on the suitability requirements for a Key Office Holder, please refer to the Code of Practice [PDF, 439KB].

Licence fee

For Cord Blood Banking Service, the applicable licence fee is $1,950.