Assisted Reproduction Service

Regulatory requirements

When is an Assisted Reproduction Service licence needed?

You will require an Assisted Reproduction Service licence if you provide any of the following services for the treatment or prevention of infertility:

1. Collect oocytes from a woman, other than via surgical excision of the woman’s ovarian tissue.

2. Screen persons who donate reproductive cells or embryos.

3. Handle, procure, process, test or store reproductive cells or embryos, including transferring reproductive cells and embryos to another Assisted Reproduction Service locally or overseas.

4. Transfer any oocyte or embryo into a woman’s body.

5. Provide any medical treatment, clinical care or laboratory procedures incidental to the services mentioned in the paragraphs above*.

*Licensees are not allowed to conduct procedures or provide services to women who do not meet the regulatory requirements for the intended procedure once a diagnosis or decision on the treatment plan has been made and consent taken to commence the intended procedure.

You will not require an Assisted Reproduction Service licence if you:

• Provide any artificial insemination procedure or any other procedure incidental to the provision of an artificial insemination procedure. If you wish to provide an artificial insemination procedure, you are required to hold an Outpatient Medical Service licence.

For the legal definition of an Assisted Reproduction Service, please refer to the First Schedule of the Act.

Applicable Specified Services and Mode of Service Delivery

**Remote provision of the Assisted Reproduction Service can only be offered when the relevant requirements as set out in Regulation 55 of the Assisted Reproduction Service Regulations are met, and where the licensee is already providing the service via the permanent premises Mode of Service Delivery.

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 obstetrics and gynaecology

   • Have work experience in the provision of a relevant Assisted Reproduction Service, which includes: Independent* in performing oocyte collections, oocyte or embryo transfers for a total of 3 years within a period of 5 years, where one year must be immediately before the individual’s appointment

*Independent performance of a procedure means there is no other medical practitioner supervising the performance of the procedure

2. In relation to the independent performance of oocyte collection, oocyte or embryo transfers (i.e., fourth bullet under S/N 1), the individual must:

   • Within a period of 3 years, independently perform at least 250 oocyte collections, oocyte or embryo transfers; or

   • Within a period of 5 years, independently perform at least 350 oocyte collections, oocyte or embryo transfers.

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

3. 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;

     • An 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 Assisted Reproduction Service, the applicable licence fee is $1,900. You do not need to pay any additional approval fee for the provision of remote services MOSD that is in conjunction with a permanent premises.

If you provide Pre-implantation Genetic Testing for Monogenic/Single Gene defects and/or Chromosomal Structural Rearrangements as a Specified Services (SS), you will have to pay an additional SS approval fee of $900 in addition to the licence fee.