Human Tissue Banking Service

Regulatory requirements

When is a Human Tissue Banking licence needed?

You will require a Human Tissue Banking licence if you:

• Handle, process, test, store and distribute any human tissue intended for subsequent therapeutic use or transplant in the same or another individual.

You will not require a Human Tissue Banking Service licence if you:

• Bank any products that are already covered under other service regulations or applicable law;

  • Cord blood (see Cord Blood Banking Service);

  • Blood or blood components, excluding cord blood (see Blood Banking Service);

  • Embryos or other reproductive cell (see Assisted Reproduction Service)

  • Any human tissue intended for the manufacture of a CTGT product (see Health Products (Cell, Tissue and Gene Therapy Products) Regulations)

• Bank any products not considered as a tissue (e.g. hair, nail, nucleic acid and excreted waste products)

• Store human tissue which are intended to be transplanted within 48 hours upon retrieval from the human body.

• Bank any products that are already covered under other service regulations or applicable law;

• Store or supply human tissue for the purpose of use in research, including human tissue to be transplanted into patients as part of research.

For the legal definition of a Human Tissue 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 Human Tissue Banking Service is permanent premises.

The following Specified Services are offered under the Human Tissue Banking Service:

• Adipose tissue

• Amniotic membrane

• Birth tissue (excluding amniotic membrane)

• Bone (excluding bone marrow)

• Cardiac tissue

• Connective tissue membrane

• Dura mater

• Epithelial membrane (except skin)

• Haematopoietic stem cell (including bone marrow)

• Lymph tissue

• Nervous tissue

• Ocular tissue

• Parathyroid tissue

• Skeletal muscle tissue

• Skin tissue

• Smooth muscle tissue

• Tendon, ligament or cartilage tissue

• Vascular tissue

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 SMC and hold a valid practising certificate

   • Be registered as a specialist* in any branch of medicine

   • Have at least 5 years of work experience in providing a Human Tissue Banking Service, blood banking or Cord Blood Banking Service.

*A specialist in the branch of medicine relevant to the specified service should be appointed to assist and advise the CGO if the CGO’s specialty is not directly relevant.

For further details on the qualifications, skills and competencies of a CGO, please refer to Section 7 of the Human Tissue Banking Service Regulations.

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

Licence fee

For Human Tissue Banking Service, the applicable licence fee is $1,050. If you provide any of the tissue types that is listed above as a Specified Service (SS), an SS approval fee will apply.