2. In this Schedule and the Second Schedule —“acute hospital service” means —| (a) | a healthcare service that is provided to a patient for the purposes of triaging to determine whether the patient needs to be admitted as an inpatient to receive care or treatment and (if it is determined that the patient need not be so admitted) stabilising his or her medical condition; | | (b) | any of the following healthcare services that is provided to an inpatient to treat a brief but severe episode of illness or any disease or trauma, or during recovery from surgery:| (i) | the examination of the inpatient’s body or mind; | | (ii) | the assessment of the inpatient’s health; | | (iii) | the observation and diagnosis of, and intervention in, the inpatient’s health condition; | | (iv) | the treatment of the inpatient for any condition, disability, disease, disorder or injury; | | (v) | the provision of medical care or dental care to the inpatient while the inpatient is being accommodated to receive that care; | | (vi) | the performance of either of the following which changes, or is intended to change, the inpatient’s appearance or anatomy: | (A) | a clinical procedure; | | (B) | an invasive procedure that penetrates beyond the epidermis layer of the inpatient’s skin; |
| | (vii) | the treatment of an inpatient who requires antenatal care, intrapartum care or postnatal care; and |
| | (c) | any other healthcare service that is incidental to the provision of a healthcare service mentioned in paragraph (a) or (b), including —| (i) | the conduct of any simple in vitro diagnostic test on the patient; and | | (ii) | the conduct of any ultrasound imaging on the patient, |
|
| but excludes a clinical laboratory service and a radiological service; |
[S 387/2023 wef 26/06/2023] |
“ambulatory surgical centre service” means —| (a) | the provision of any surgical procedure, or other procedure that is performed with the administration of anaesthetics, to an individual who, at the start of the procedure, is not assessed by a medical practitioner or dentist to require accommodation for the purposes of receiving medical observation or care for a period exceeding 12 hours after the individual is admitted for the procedure; and | | (b) | any ancillary healthcare service, |
| but excludes any of the following: |
| (c) | provision of any relevant procedure that does not require general anaesthesia, by a person who is licensed to provide any of the following licensable healthcare services:| (i) | a community hospital service; | | (ii) | a contingency care service; | | (iii) | an outpatient dental service; | | (iv) | an outpatient medical service; | | (v) | an outpatient renal dialysis service; |
| | (d) | provision of any relevant procedure by a person who is licensed to provide an acute hospital service to any inpatient; | | (e) | provision of any relevant procedure that is an assisted reproduction procedure by a person who is licensed to provide an assisted reproduction service; | | (f) | provision of any relevant procedure that is performed with the administration of anaesthetics by a person who is licensed to provide a nuclear medicine service or radiological service; [S 387/2023 wef 26/06/2023] |
|
“ancillary healthcare service”, in relation to an individual on whom a relevant procedure is or is to be performed at any premises, means any of the following that is carried out from the time the individual is admitted for the procedure until the individual leaves the premises, and that is incidental to the procedure and does not involve the provision of a clinical laboratory service or radiological service:| (a) | the examination of the individual’s body or mind; | | (b) | the conduct of any simple in vitro diagnostic test on the individual; | | (c) | the conduct of ultrasound imaging on the individual; | | (d) | the assessment of the individual’s health; | | (e) | the observation and diagnosis of, and intervention in, the individual’s health condition; | | (f) | the treatment of the individual for any condition, disability, disease, disorder or injury; | | (g) | the provision of medical care or dental care to the individual; [S 387/2023 wef 26/06/2023] |
|
“assisted reproduction service” means the provision of any of the following services for the treatment or prevention of infertility:| (aa) | the stimulation of the ovaries of a woman; [S 800/2023 wef 18/12/2023] | | (a) | the collection of oocytes from a woman, other than by way of surgical excision of the woman’s ovarian tissue; | | (b) | the screening of persons who donate reproductive cells or embryos; | | (c) | the handling, procurement, processing, testing or storage of reproductive cells or embryos for the subsequent distribution (including for the transfer into the body of a woman) of the reproductive cells or embryos; | | (d) | the transfer of any oocyte or embryo into the body of a woman; | | (e) | any medical treatment, clinical care or laboratory procedures incidental to the services mentioned in paragraph (aa), (a), (b), (c) or (d), |
| but excludes the provision of any artificial insemination procedure or any other procedure incidental to the provision of an artificial insemination procedure; |
[S 387/2023 wef 26/06/2023] [S 800/2023 wef 18/12/2023] |
| “blood” means whole human blood; |
“blood banking service” means a service relating to blood or blood components for therapeutic transfusion that comprises all or any of the following activities:| (a) | the collection of blood or blood components; | | (b) | the testing, processing and distribution of blood or blood components; | | (c) | the storage of blood or blood components incidental to any activity mentioned in paragraph (a) or (b), |
| and includes the conduct of any simple in vitro diagnostic test on an individual, but excludes any of the following: |
| (d) | the temporary storage of any blood or blood component by a specified person, where the storage is incidental to the provision of the blood or blood component to the patients of the specified person; | | (e) | the temporary storage by a specified person (A) of any blood or blood component received from another specified person (B), where —| (i) | the blood or blood component is intended to be provided by A to B’s patients; and | | (ii) | the storage is incidental to A’s provision of the blood or blood component to B’s patients; |
| | (f) | the distribution of any blood or blood component to a specified person (C) on a named patient basis, where C does not further distribute the blood or blood component to another specified person (D) for use by any patient of D other than on a named patient basis; | | (g) | the distribution of any blood or blood component that is approaching its expiry date in the possession of a specified person to another specified person, for the sole purpose of preventing the wastage of the blood or blood component, as the case may be; | | (h) | the distribution of any blood or blood component in the possession of a specified person to another specified person in response to a national emergency or any other emergency (such as a fire or an explosion) that causes loss of life or injury to individuals; | | (i) | a cord blood banking service; [S 387/2023 wef 26/06/2023] |
|
| “blood component” includes plasma, red blood cells, white blood cells, platelets and cryoprecipitate; |
“clinical laboratory service” means the examination or testing of any matter derived, obtained or excreted from the body of any individual for any of the following purposes:| (a) | assessing the health or genetic predisposition of that individual or any other individual; | | (b) | predicting or providing a prognosis of the health condition of that individual or any other individual; | | (c) | diagnosing any condition, disability, disease, disorder or injury of that individual or any other individual; | | (d) | determining the intervention to be taken, or the effect of any intervention taken, of any condition, disability, disease, disorder or injury of an individual; | | (e) | ascertaining the result of a medical or surgical treatment given to that individual or any other individual; | | (f) | assessing the health, condition or suitability of any human biological material that is used, or is intended to be used, in relation to any healthcare service, |
| and includes the storage or distribution of any blood or blood component incidental to the examination or testing of the blood or blood component for a purpose specified in paragraphs (a) to (f), but excludes any of the following: |
| (g) | the testing of any matter derived, obtained or excreted from the body of any individual that only involves the use of a simple in vitro diagnostic test by a person who is licensed to provide any of the following licensable healthcare services, where the testing is incidental to the provision of the licensable healthcare service:| (i) | an acute hospital service; | | (ii) | an ambulatory surgical centre service; | | (iii) | an assisted reproduction service; | | (iv) | a blood banking service; | | (v) | a community hospital service; | | (vi) | a contingency care service; | | (vii) | an emergency ambulance service; | | (viii) | a medical transport service; | | (ix) | a nuclear medicine service; | | (x) | an outpatient dental service; | | (xi) | an outpatient medical service; | | (xii) | an outpatient renal dialysis service; | | (xiii) | a radiological service; | | (xiv) | a nursing home service; [S 800/2023 wef 18/12/2023] |
| | (h) | the examination of a breath sample to determine its aggregate physical characteristics (including its weight, volume or rate of flow) and not to determine the presence or quantity of any component matter; | | (i) | [Deleted by S 800/2023 wef 18/12/2023] [S 387/2023 wef 26/06/2023] |
|
“community hospital service” means —| (a) | any of the following healthcare services that is provided to an inpatient who, having been treated for any disease or trauma or having undergone surgery, needs to receive constant medical oversight by a medical practitioner, for the purpose of assisting the inpatient to regain his or her health or physical functions or providing palliative care to the inpatient: | | (b) | any other healthcare service that is incidental to the provision of a healthcare service mentioned in paragraph (a)(i) to (vii), including — |
| but excludes the following: |
| (c) | any specialised treatment given to an inpatient who is acutely unwell and requires critical medical care; | | (d) | the conduct of any surgical procedure, other than a minor dental surgical procedure or minor surgical procedure; | | (e) | the provision of any treatment or conduct of any procedure on an inpatient that requires the inpatient to be in a state of general anaesthesia; | | (f) | the administration of any anaesthetic to cause general anaesthesia in an inpatient; [S 387/2023 wef 26/06/2023] |
|
“contingency care service” means —| (a) | a healthcare service that is provided to an inpatient for the purpose of treatment for an infectious disease specified in the First Schedule to the Infectious Diseases Act 1976; | | (b) | a healthcare service that is provided to an inpatient who, having been treated for any disease or trauma or having undergone surgery, needs to receive constant medical oversight by a medical practitioner, for the purpose of assisting the inpatient in regaining his or her health or physical functions; and | | (c) | any of the following healthcare services:| (i) | the examination of the inpatient’s body or mind; | | (ii) | the assessment of the inpatient’s health; | | (iii) | the observation and diagnosis of, and intervention in, the inpatient’s health condition; | | (iv) | the treatment of the inpatient for any condition, disability, disease, disorder or injury; | | (v) | the provision of medical care or dental care to the inpatient while the inpatient is being accommodated to receive that care; | | (vi) | the performance of either of the following which changes, or is intended to change, the inpatient’s appearance or anatomy: | (A) | a clinical procedure; | | (B) | an invasive procedure that penetrates beyond the epidermis layer of the inpatient’s skin; |
| | (vii) | the rehabilitation of an inpatient; | | (viii) | any other healthcare service that is incidental to the provision of a healthcare service mentioned in paragraph (a) or (b), including —| (A) | the conduct of any simple in vitro diagnostic test on the inpatient; and | | (B) | the conduct of any ultrasound imaging on the inpatient, |
|
|
| but excludes the following: |
| (d) | any specialised treatment given to an inpatient who is acutely unwell and requires critical medical care; | | (e) | the conduct of any surgical procedure, other than a minor dental surgical procedure or minor surgical procedure; | | (f) | the provision of palliative care; | | (g) | the provision of any treatment or conduct of any procedure on an inpatient that requires the inpatient to be in a state of general anaesthesia; | | (h) | the administration of any anaesthetic to cause general anaesthesia in an inpatient; [S 387/2023 wef 26/06/2023] |
|
| “cord blood” means the whole blood (including haematopoietic progenitor cells) remaining in the placental and umbilical cord blood vessels after an umbilical cord has been clamped; |
“cord blood banking service” —| (a) | means —| (i) | the handling, processing and storage of cord blood; and | | (ii) | the distribution of cord blood for use with any individual (including the individual from whom the cord blood was obtained); and |
| | (b) | includes the screening of donors of cord blood; |
|
| “CTGT product” means a health product categorised as a cell, tissue or gene therapy product in the First Schedule to the Health Products Act 2007; [S 387/2023 wef 26/06/2023] |
“embryo” means any live embryo that has a human genome or an altered human genome and that has been developing for less than 14 days since —| (a) | its fertilisation; | | (b) | the appearance of 2 pro-nuclei; or | | (c) | the initiation of its development by other means; [S 387/2023 wef 26/06/2023] |
|
“emergency ambulance” means a vehicle which —| (a) | is used or intended to be used to convey by land any patient (including an emergency patient); and | | (b) | is equipped for the provision of clinical care to, and the clinical monitoring of, the patient while the patient is being conveyed; |
|
“emergency ambulance service” means —| (a) | the conveyance by land using an emergency ambulance of any patient (including an emergency patient); and | | (b) | the provision of clinical care to, and the clinical monitoring of, the patient while the patient is being conveyed in the emergency ambulance; |
|
| “emergency patient” means an individual who is suffering or believed to be suffering from an injury, or a condition of acute or sudden onset, that poses an immediate threat to the individual’s life or jeopardises the long-term health of the individual; |
“general anaesthesia” means a drug-induced loss of a patient’s consciousness —| (a) | during which the patient is not arousable even with painful stimulation; | | (b) | where the patient’s ability to independently maintain ventilatory function is often impaired; | | (c) | where the patient often requires assistance in maintaining a patent airway and positive pressure ventilation may be required because of depressed respiratory function or drug-induced depression of neuromuscular function; and | | (d) | where the patient’s cardiovascular function may be impaired; [S 387/2023 wef 26/06/2023] |
|
| “haemodialysis” means the removal of uremic toxins from an individual with end stage kidney failure with the use of a haemodialysis machine, to ensure the balance of acids, electrolytes and fluids in the body of the individual; [S 387/2023 wef 26/06/2023] |
“human tissue banking service” means the handling, processing, testing, storage and distribution of any human tissue (other than a specified human tissue) that is —| (a) | collected or derived from the body of an individual; and | | (b) | intended to be distributed for subsequent therapeutic use, |
| but excludes the handling, processing and temporary storage of any human tissue that is intended for transplant for therapeutic purposes within 48 hours after the human tissue is collected or derived from the body of an individual; |
[S 387/2023 wef 26/06/2023] |
| “inpatient” means a patient other than an outpatient; [S 387/2023 wef 26/06/2023] |
| “irradiating apparatus” and “radioactive material”, in relation to a nuclear medicine service, have the meanings given by section 2(1) of the Radiation Protection Act 2007; [S 387/2023 wef 26/06/2023] |
| “medical condition”, in relation to a patient, includes the patient’s dental condition; [S 387/2023 wef 26/06/2023] |
| “medical observation”, in relation to an individual, means the observation of the individual’s health condition by a medical practitioner, a dentist, a registered nurse or an enrolled nurse (as the case may be) for the purpose of determining whether the individual is fit for discharge; [S 387/2023 wef 26/06/2023] |
“medical transport” means a vehicle (other than an emergency ambulance) which —| (a) | is used or intended to be used to convey by land any patient (except a patient who is an emergency patient before being conveyed); and | | (b) | is equipped for the clinical care and monitoring of the patient, if necessary, while the patient is being conveyed; |
|
“medical transport service” means —| (a) | the conveyance by land using a medical transport of any patient (except a patient who is an emergency patient before being conveyed); and | | (b) | the clinical care and monitoring of the patient, if necessary, while the patient is being conveyed in the medical transport; |
|
| [Deleted by S 387/2023 wef 26/06/2023] |
| [Deleted by S 387/2023 wef 26/06/2023] |
| [Deleted by S 387/2023 wef 26/06/2023] |
“minor dental surgical procedure” means a dental surgical procedure that —| (a) | is associated with minimal tissue damage and blood loss; and | | (b) | may be safely performed in an environment other than an operating theatre; [S 387/2023 wef 26/06/2023] |
|
“minor surgical procedure” means a surgical procedure that —| (a) | is associated with minimal tissue damage and blood loss; and | | (b) | may be safely performed in an environment other than an operating theatre; [S 387/2023 wef 26/06/2023] |
|
“nuclear medicine service” means the administration of radiopharmaceuticals to a patient for or in relation to the assessment, diagnosis, treatment, prevention or alleviation of any ailment, condition, disability, disease, disorder or injury affecting any part of the body or mind of the patient, and includes —| (a) | the provision of any healthcare service that is incidental to the provision of the administration of radiopharmaceuticals, including —| (i) | the conduct of any simple in vitro diagnostic test on the patient; and | | (ii) | the conduct of any ultrasound imaging on the patient; |
| | (b) | the derivation, after the administration of radiopharmaceuticals, of any specimen from the patient; | | (c) | the testing of any specimen mentioned in paragraph (b) using beta scintillation or gamma counting; and | | (d) | the imaging, after the administration of radiopharmaceuticals, of the individual through the use of any irradiating apparatus; [S 387/2023 wef 26/06/2023] |
|
“nursing home service” means —| (a) | any of the following healthcare services that is provided to an inpatient who is an elderly or a disabled person, or is labouring under a life‑limiting condition or illness, and requires continuous nursing care but does not require continuous onsite supervision by a medical practitioner:| (i) | the examination of the inpatient’s body or mind; | | (ii) | the assessment of the inpatient’s health; | | (iii) | the observation and diagnosis of, and intervention in, the inpatient’s health condition; | | (iv) | the treatment of the inpatient for any condition, disability, disease, disorder or injury; | | (v) | the provision of medical care to the inpatient while the inpatient is being accommodated to receive that care; | | (vi) | the rehabilitation of an inpatient for the purpose of slowing down the disabling effects of the inpatient’s health condition and functional abilities; | | (vii) | the provision of palliative care to an inpatient; and |
| | (b) | any other healthcare service that is incidental to the provision of a healthcare service mentioned in paragraph (a)(i) to (v), including —| (i) | the conduct of any simple in vitro diagnostic test on the inpatient; and | | (ii) | the conduct of any ultrasound imaging on the inpatient, |
|
| but excludes the following: |
| (c) | the provision of any dental care, treatment or procedure to an inpatient, other than assisting the inpatient in cleaning his or her teeth or mouth to ensure the oral hygiene of the inpatient; | | (d) | any specialised treatment given to an inpatient who is acutely unwell and requires critical medical care; | | (e) | the conduct of any surgical procedure, other than a minor surgical procedure; | | (f) | the provision of any treatment or conduct of any procedure on an inpatient that requires the inpatient to be in a state of general anaesthesia; | | (g) | the administration of any anaesthetic to cause general anaesthesia in an inpatient; [S 800/2023 wef 18/12/2023] |
|
| “oocyte” means a live human oocyte and includes the cells of the female germ line at any stage of maturity but excludes an oocyte that is in the process of fertilisation or undergoing any other process capable of creating an embryo; [S 387/2023 wef 26/06/2023] |
| “outpatient” means an individual who is provided a healthcare service that excludes the provision of accommodation for more than 12 hours; [S 387/2023 wef 26/06/2023] |
“outpatient dental service” means any of the following healthcare services that is provided to an outpatient:| (a) | the performance of any procedure and the treatment of any disease, deficiency, deformity, malposition or lesion on or of the outpatient’s teeth or jaws or associated structures, whether intraorally or extraorally; | | (b) | the performance of radiographic work in connection with the outpatient’s teeth or jaws or associated structures; | | (c) | the administration of an anaesthetic in connection with any procedure on the outpatient’s teeth or jaws or associated structures; | | (d) | the performance of any procedure on, or the giving of any treatment, advice or attendance to, an outpatient as preparatory to, or for the purpose of or for or in connection with, the fitting, inserting, fixing, constructing, repairing or renewing of dentures or dental appliances; | | (e) | the performance of any procedure and the giving of any treatment, advice or attendance as is usually performed or given by dentists; | | (f) | any other healthcare service that is incidental to the provision of a healthcare service mentioned in paragraphs (a) to (e), including —| (i) | the conduct of any simple in vitro diagnostic test on the outpatient; and | | (ii) | the conduct of any ultrasound imaging on the outpatient, |
|
| but excludes the following: |
| (g) | the provision of any treatment or conduct of any procedure on an outpatient that requires the outpatient to be in a state of general anaesthesia; | | (h) | the administration of any anaesthetic to cause general anaesthesia in an outpatient; | | (i) | the conduct of any surgical procedure, other than a minor dental surgical procedure; | | (j) | triaging to determine whether a patient needs to be admitted as an inpatient to receive care or treatment, and (if it is determined that the patient need not be so admitted) stabilising the patient’s medical condition; | | (k) | any provision of an ambulatory surgical centre service; [S 387/2023 wef 26/06/2023] |
|
“outpatient medical service” means any of the following healthcare services that is provided to an outpatient:| (a) | the examination of the outpatient’s body or mind; | | (b) | the assessment of the outpatient’s health; | | (c) | the observation and diagnosis of, and intervention in, the outpatient’s health condition; | | (d) | the treatment of the outpatient for any condition, disability, disease, disorder or injury; | | (e) | the provision of medical care to the outpatient; | | (f) | the performance of either of the following which changes, or is intended to change, the outpatient’s appearance or anatomy: | (i) | a clinical procedure; | | (ii) | an invasive procedure that penetrates beyond the epidermis layer of the outpatient’s skin; |
| | (g) | any other healthcare service that is incidental to the provision of a healthcare service mentioned in paragraphs (a) to (f), including —| (i) | the conduct of any simple in vitro diagnostic test on the outpatient; and | | (ii) | the conduct of any ultrasound imaging on the outpatient, |
|
| but excludes the following: |
| (h) | the provision of any treatment or conduct of any procedure on an outpatient that requires the outpatient to be in a state of general anaesthesia; | | (i) | the administration of any anaesthetic to cause general anaesthesia in an outpatient; | | (j) | the conduct of any surgical procedure, other than a minor surgical procedure; | | (k) | triaging to determine whether a patient needs to be admitted as an inpatient to receive care or treatment, and (if it is determined that the patient need not be so admitted) stabilising the patient’s medical condition; | | (l) | any provision of haemodialysis, or clinical care that is incidental to the provision of haemodialysis; | | (m) | any provision of an ambulatory surgical centre service, an assisted reproduction service, a clinical laboratory service, a nuclear medicine service or a radiological service; | | (n) | the certification of the death of any individual; [S 387/2023 wef 26/06/2023] |
|
| “outpatient renal dialysis service” means the provision of haemodialysis or peritoneal dialysis support only to outpatients, and includes the provision of any healthcare service that is incidental to the provision of haemodialysis or peritoneal dialysis support, other than a clinical laboratory service or radiological service, but excludes the provision of peritoneal dialysis support by a person who is licensed to provide an outpatient medical service; [S 387/2023 wef 26/06/2023] |
| “peritoneal dialysis” means the removal of uremic toxins from an individual with end stage kidney failure through the blood vessels in the individual’s peritoneum by a dialysis solution, to ensure the balance of acids, electrolytes and fluids in the body of the individual; [S 387/2023 wef 26/06/2023] |
“peritoneal dialysis support” means both of the following services:| (a) | teaching a patient to perform peritoneal dialysis in a home setting, for himself or herself; | | (b) | providing medical or nursing care and treatment for a peritoneal dialysis patient who develops or may develop complications or requires assistance with the performance of peritoneal dialysis; [S 387/2023 wef 26/06/2023] |
|
“radiological service” means the use of ionising or non-ionising radiation for any of the following purposes:| (a) | examination of the body, or any matter derived from the body, of an individual; | | (b) | assessment of the health or medical condition of an individual; | | (c) | observation and diagnosis of any condition, disability, disease, disorder or injury of an individual; | | (d) | determining, predicting or providing a prognosis of the health or condition of an individual; | | (e) | minimally invasive image-guided biopsy of breast, thyroid, any superficial lump or bump or any superficial lymph node, |
| but excludes any of the following: |
| (f) | the provision of any dental cone beam computed tomography for dental purposes by a person who is licensed to provide an outpatient dental service and approved under section 11D to provide dental cone beam computed tomography; | | (g) | the provision of any periapical x-ray or orthopantomogram for dental purposes by a person who is licensed to provide an outpatient dental service; | | (h) | the provision of ultrasound imaging by a person who is licensed to provide any of the following licensable healthcare services, where the provision of ultrasound imaging is incidental to the provision of the licensable healthcare service:| (i) | an acute hospital service; | | (ii) | an ambulatory surgical centre service; | | (iii) | an assisted reproduction service; | | (iv) | a community hospital service; | | (v) | a contingency care service; | | (vi) | a nuclear medicine service; | | (vii) | an outpatient dental service; | | (viii) | an outpatient medical service; | | (ix) | an outpatient renal dialysis service; | | (x) | a nursing home service; [S 800/2023 wef 18/12/2023] |
| | (i) | the provision of any radiological examination involving the use of ionising or non-ionising radiation for a purpose mentioned in paragraphs (a) to (e) by a person who is licensed to provide a nuclear medicine service; | | (j) | [Deleted by S 800/2023 wef 18/12/2023] |
|
| “radiopharmaceutical”, in relation to a nuclear medicine service, means any radioactive material that is administered to a patient as a diagnostic or therapeutic agent, but excludes any sealed source within the meaning given by regulation 2 of the Radiation Protection (Ionising Radiation) Regulations 2023 (G.N. No. S 85/2023); [S 387/2023 wef 26/06/2023] |
“relevant procedure” means —| (a) | any surgical procedure; or | | (b) | any other procedure performed with the administration of anaesthetics, |
| that is performed on an individual who, at the start of the procedure, is not assessed by a medical practitioner or dentist to require accommodation for the purposes of receiving medical observation or care for a period exceeding 12 hours after the individual is admitted for the procedure; |
[S 387/2023 wef 26/06/2023] |
| “reproductive cell” means any human gamete or germ cell at any stage of maturity and includes any human tissue containing any human gamete or germ cells at any stage of maturity; [S 387/2023 wef 26/06/2023] |
“simple in vitro diagnostic test” means an in vitro diagnostic test that is designed to return a test result without the need to interpret raw test data and requires —| (a) | no specimen processing; | | (b) | no more than 3 steps of analytical test procedures; | | (c) | the use of self-contained reagent cartridges or strips or no precise measurement required for reagent preparation; | | (d) | no specifications for a controlled testing environment for returning an accurate test result; and | | (e) | only portable analysers with automated calibration, quality control and self-diagnosing malfunction features when used; |
|
“specified human tissue” means any of the following:| (a) | any blood or blood component; | | (b) | any therapeutic product that is derived from blood or any blood component; | | (c) | any cord blood; | | (d) | any embryo; | | (e) | any reproductive cell; | | (f) | any hair; | | (g) | any nail; | | (h) | any naturally excreted or secreted bodily fluids or waste products; | | (i) | any human tissue intended for the manufacture of a CTGT product; | | (j) | any nucleic acid; [S 387/2023 wef 26/06/2023] |
|
“specified person”, in relation to a licensee authorised to provide a blood banking service, means any of the following persons to whom a licensee distributes blood or blood components:| (a) | another licensee who is authorised to provide a blood banking service; | | (b) | a licensee who is authorised to provide any of the following licensable healthcare services:| (i) | an acute hospital service; | | (ii) | an ambulatory surgical centre service; | | (iii) | a clinical laboratory service; |
| | (c) | a licensee who —| (i) | is authorised to provide a licensable healthcare service other than a licensable healthcare service mentioned in paragraph (b); and | | (ii) | is approved under section 11D to provide a blood transfusion service for the licensable healthcare service mentioned in sub-paragraph (i); |
| | (d) | [Deleted by S 800/2023 wef 18/12/2023] [S 387/2023 wef 26/06/2023] |
|
“surgical procedure” means —| (a) | an invasive operative procedure during which skin or mucous membranes and connective tissue are incised; or | | (b) | a procedure that is carried out using an instrument that is introduced through a natural body orifice. [S 387/2023 wef 26/06/2023] |
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