Healthcare Services (Assisted Reproduction Service) Regulations 2023

No. S 429

Healthcare Services Act 2020

Healthcare Services
(Assisted Reproduction Service)
Regulations 2023

In exercise of the powers conferred by section 57 of the Healthcare Services Act 2020, the Minister for Health makes the following Regulations:

PART 1

PRELIMINARY

Citation and commencement

1. These Regulations are the Healthcare Services (Assisted Reproduction Service) Regulations 2023 and come into operation on 26 June 2023.

Definitions

2. In these Regulations —

“assisted reproduction cycle”, in relation to a patient, means the patient’s menstrual cycle —

(a)	that is a stimulated cycle; or
(b)	any menstrual cycle other than a stimulated cycle, in which any oocyte was collected or attempted to be collected from, or any oocyte or embryo was transferred into, the body of the patient;

“assisted reproduction procedure” means any of the following:

(a)	the collection of oocytes from a woman, other than by way of surgical excision of the woman’s ovarian tissue;
(b)	the fertilisation of an oocyte for the subsequent distribution (including transfer into the body of a woman) of the embryo;
(c)	the transfer of any oocyte or embryo into the body of a woman;
(d)	any removal of cells from an embryo for the purpose of testing the embryo;

“assisted reproduction service”, “embryo”, “oocyte” and “reproductive cell” have the meanings given by paragraph 2 of the First Schedule to the Act;

“calendar day” includes Saturday, Sunday and every public holiday;

“donor”, in relation to any reproductive cell or embryo, means the individual from whose body the reproductive cell is collected, or from whose reproductive cells the embryo is created, but excludes a patient or a patient’s husband;

“elective oocyte storage”, in relation to a patient, means —

(a)	the administration of gonadotropins to the patient for the collection of oocytes from the patient;
(b)	the collection of oocytes from the patient; and
(c)	the storage of the oocytes collected from the patient,

where none of the collected oocytes are fertilised before the storage of the oocytes;

“embryology laboratory” means any place equipped to carry out any of the following:

(a)	culture medium preparation and quality control testing in relation to preparation of reproductive cells or embryos for cryopreservation, maturation, fertilisation, treatment or distribution;
(b)	examination of follicular aspirates with oocyte identification;
(c)	oocyte quality and maturing grading;
(d)	sperm analysis in relation to sperm selection for IVF or ICSI and sperm washing and capacitation;
(e)	insemination of oocytes via IVF or ICSI;
(f)	determination of fertilisation;
(g)	embryo culture and embryo quality and maturation grading;
(h)	preparation of embryos for embryo transfer (either uterine or tubal);
(i)	reproductive cell or embryo cryopreservation or storage;
(j)	micromanipulation of reproductive cells or embryos;

“embryology procedure” means any of the following procedures:

(a)	the examination of follicular aspirates;
(b)	oocyte classification;
(c)	sperm preparation for subsequent use in an assisted reproduction procedure or distribution;
(d)	oocyte insemination (whether by IVF or ICSI);
(e)	documentation of fertilisation;
(f)	preparation of embryos for transfer;

“essential life‑saving measure” means any basic emergency procedure that may be carried out on a person for the purpose of resuscitating the person;

“General Regulations” means the Healthcare Services (General) Regulations 2021 (G.N. No. S 1035/2021);

“ICSI” means intracytoplasmic sperm injection;

“IVF” means in vitro fertilisation;

“licensee” means a person who holds a licence to provide an assisted reproduction service;

“patient”, in relation to a licensee, means any woman who receives an assisted reproduction service from the licensee;

“pre‑implantation genetic testing” means the biopsy of any cell from a blastocyst created by IVF or ICSI;

“qualified assisted reproduction practitioner” means a medical practitioner who fulfils the criteria mentioned in regulation 11(1);

“qualified embryologist” means a person who fulfils the criteria mentioned in regulation 11(2);

“recipient”, in relation to a reproductive cell or an embryo that is transferred, means the woman into whose body the reproductive cell or embryo is transferred;

“relevant assisted reproduction service” means an assisted reproduction service —

(a)	licensed under the Act; or
(b)	in a medical clinic or an acute hospital that is licensed under the Private Hospitals and Medical Clinics Act 1980 and approved to provide assisted reproduction services;

“restricted procedure”, in relation to a patient, means any of the following assisted reproduction procedures:

(a)	the fertilisation of the oocytes collected from the patient with the sperm of any man by IVF or ICSI;
(b)	the transfer of any oocyte or embryo into the body of the patient;

“sperm” means live human sperm and includes the cells of the male germ line at any stage of maturity;

“stimulated cycle”, in relation to a patient, means the patient’s menstrual cycle in which —

(a)	gonadotropins have been administered to the patient during the menstrual cycle; and
(b)	one or more oocytes are collected or attempted to be collected from the patient,

whether or not any oocyte or embryo is transferred into the body of the patient.

Application of Regulations

3. Unless otherwise expressly provided in these Regulations, the provisions of these Regulations —

(a)	apply in addition to the provisions of the General Regulations; and
(b)	prevail if, and to the extent that, there is any inconsistency between these Regulations and the General Regulations insofar as the matter relates to a licensee.

Specified services

4. For the purposes of section 9A(1) of the Act, the services set out in the Schedule are specified services for an assisted reproduction service.

Prohibited service delivery modes

5. A licensee must not provide an assisted reproduction service using any of the following service delivery modes:

(a)	at any premises other than permanent premises;
(b)	using a conveyance.

Mandatory services

6. A licensee must —

(a)	in the provision of the assisted reproduction service to any patient, provide clinical care incidental to the collection of oocytes from the patient or the screening of donors of reproductive cells or embryos; and
(b)	be equipped and capable of providing the service of transferring an oocyte or embryo into the body of a patient.

Made on 21 June 2023.

CHAN YENG KIT

Permanent Secretary,
Ministry of Health,
Singapore.

[MH 78:44/1; AG/LEGIS/SL/122E/2020/28 Vol. 1]

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