Health Products Act 2007 - Singapore Statutes Online

FIRST SCHEDULE

Sections 2(1), 4, 29(1), 73(1) and 75

Categories and descriptions of
health products to which Act applies

First column

Second column

Third column

Category

Description

Exceptions and limitations

1.	Medical device

“Medical device” means —

(a)	any instrument, apparatus, implement, machine, appliance, implant, reagent for in‑vitro use, software, material or other similar or related article that is intended by its manufacturer to be used, whether alone or in combination, for humans for one or more of the specific purposes of —

(i)	diagnosis, prevention, monitoring, treatment or alleviation of disease;

(ii)	diagnosis, monitoring, treatment or alleviation of, or compensation for, an injury;

(iii)

investigation, replacement, modification or support of the anatomy or of a physiological process, mainly for medical purposes;

(iv)	supporting or sustaining life;

(v)	control of conception;

(vi)	disinfection of medical devices; or

(vii)

providing information by means of in‑vitro examination of specimens derived from the human body, for medical or diagnostic purposes,

and which does not achieve its primary intended action in or on the human body by pharmacological, immunological or metabolic means, but which may be assisted in its intended function by such means, and which is not a cell, tissue or gene therapy product; and

(b)	the following articles:

(i)	any implant for the modification or fixation of any body part;

(ii)	any injectable dermal filler or mucous membrane filler;

(iii)

any instrument, apparatus, implement, machine or appliance intended to be used for the removal or degradation of fat by invasive means.

2.	Cosmetic products

“Cosmetic product” means any substance or preparation that is intended by its manufacturer to be placed in contact with the various external parts of the human body or with the teeth or the mucous membranes of the oral cavity, with a view exclusively or mainly to —

(a)	cleaning them;

(b)	perfuming them;

(c)	changing their appearance;

(d)	correcting body odours;

(e)	protecting them; or

(f)	keeping them in good condition.

Sections 12(1), (2) and (3), 13(1), (2) and (3), 14(1) and (2), 15 and 19(1)(b), and Parts 6 and 7 do not apply.

3.	Therapeutic product

(1)	“Therapeutic product” means any substance that —

(a)	is intended for use by and in humans for a therapeutic, preventive, palliative or diagnostic purpose, including any of the following purposes:

(i)	for preventing, diagnosing, monitoring, treating, curing or alleviating any disease, disorder, ailment, injury, handicap or abnormal physical or mental state, or any symptom thereof;

(ii)	for investigating, modifying or replacing any physiological process;

(iii)

for influencing, controlling or preventing conception;

(iv)	for inducing anaesthesia;

(b)	has as a constituent any of the following active ingredients:

(i)	any chemical or botanical element, naturally‑occurring chemical or botanical material, or chemical product obtained by chemical change or synthesis;

(ii)	any metabolite from a micro‑organism;

(iii)

any macromolecule extracted from an organism;

(iv)	any substance derived from a biological system, including any of the following:

(A)	a whole cell or micro‑organism, such as a whole virus or bacterium used as a vaccine;

(B)	a part of a micro‑organism, such as a sub‑unit vaccine;

(C)	a plasma‑derived product;

(D)	a biotechnology‑derived substance, such as a protein or polypeptide, or a recombinant vaccine for a preventive purpose;

(c)	exerts an inherent effect either pharmacologically, chemically or by other physiological means, leading to its use for a therapeutic, preventive, palliative or diagnostic purpose; and

(d)	is not any of the following:

(i)	a medical device;

(ii)	a cell, tissue or gene therapy product;

(iii)

whole blood or any blood component;

(iv)	any Chinese proprietary medicine;

(v)	any homoeopathic medicine;

(vi)	any medicated oil or balm;

(vii)

any quasi‑medicinal product;

(viii)

any traditional medicine.

(2)	For the purposes of paragraph (1) —

“Chinese proprietary medicine” means any medicinal product used in the system of therapeutics according to the traditional Chinese method, that is to say, any medicinal product —

(a)	which has been manufactured into a finished product;

(b)	which contains one or more active substances derived wholly from any plant, animal or mineral, or any combination thereof;

(c)	which is, or all of the active substances of which are, described in the current edition of “A Dictionary of Chinese Pharmacy” «中药大辞典» or “The Chinese Herbal Medicine Materia Medica” «本草纲目»;

(d)	which does not contain as an active substance any chemically‑defined isolated constituent of any plant, animal or mineral, or any combination thereof; and

(e)	which is not intended to be administered by injection into a human body;

“current edition”, in relation to any publication which describes a Chinese proprietary medicine, means the latest edition that has taken effect when the Chinese proprietary medicine in question is supplied, and includes that edition as affected by every amendment, addition or deletion to that edition that has taken effect;

“homoeopathic medicine” means any substance used in the system of therapeutics in which a disease is treated by the use of minute amounts of one or more substances which, in their undiluted forms, are capable of producing in healthy humans symptoms similar to those of the disease being treated;

“medicated oil or balm” means any external medicated embrocation, medicated cream, ointment or inhalant, and which contains one or more of the following active ingredients:

(a)	any essential oil;

(b)	any fixed oil derived from plants;

(c)	methyl salicylate;

(d)

menthol;

(e)

camphor;

(f)	peppermint;

“medicinal product” has the meaning given by the Medicines Act 1975;

“quasi‑medicinal product” means —

(a)	any anti‑dandruff preparation;

(b)	any medicated cosmetic product for the treatment of pimples or acne, except any preparation containing etretinate or 13‑cis‑retinoic acid;

(c)	any medicated soap;

(d)	any sweet for relieving coughs or throat irritations;

(e)	any medicated plaster;

(f)	any sunscreen or suntan preparation;

(g)	any medicated beverage;

(h)	any vitamin or nutritional preparation from any natural source; or

(i)	any medicated toothpaste;

“traditional medicine” means any medicinal product consisting of one or more substances derived from any plant, animal or mineral, or any combination thereof, but does not include the following:

(a)	any medicinal product to be administered by injection into a human body;

(b)	any vaccine to be administered to a human;

(c)	any product derived from human blood;

(d)	any item specified in the Poisons List in the Schedule to the Poisons Act 1938;

(e)	any Chinese proprietary medicine.

4.	Oral dental gum

“Oral dental gum” means any chewing gum, or any similar substance prepared from a gum base of vegetable or synthetic origin, and intended to be chewed for use in promoting dental health or oral hygiene, but does not include any such gum which is manufactured or imported into Singapore solely for research and development purposes by a person who is registered under the Control of Manufacture Act 1959 in respect of the manufacture of chewing gum.

5.	Cell, tissue or gene therapy product

(1)	“Cell, tissue or gene therapy product” means any substance that —

(a)	is intended for use by and in humans for a therapeutic, preventive, palliative or diagnostic purpose, including any of the following purposes:

(i)	for preventing, diagnosing, treating, curing or alleviating any disease, disorder, injury, ailment, handicap or abnormal physical or mental state, or any symptom thereof;

(ii)	for replacing, repairing, regenerating or reconstructing any anatomy, or for modifying or replacing any physiological process;

(iii)

for regulating, repairing, replacing, adding or deleting a genetic sequence or modifying genetic material;

(iv)	for supporting or sustaining life;

(b)	has as a constituent any of the following substances or combination of substances:

(i)	viable or non‑viable human cells or tissues;

(ii)	viable animal cells or tissues;

(iii)

recombinant nucleic acids, where the effect of the recombinant nucleic acid relates directly to the recombinant nucleic acid sequence that it contains or to the product of the genetic expression of its sequence;

(c)	achieves its primary intended action by pharmacological, immunological, physiological, metabolic or physical means, leading to its use for a therapeutic, preventive, palliative or diagnostic purpose; and

(d)	is not any of the following:

(i)	a recombinant vaccine for a preventive purpose;

(ii)	an in‑vitro diagnostic product;

(iii)

bone marrow, peripheral blood or umbilical or placental cord blood from a human that is minimally manipulated and intended for homologous use;

(iv)	cells and tissues obtained from a patient that are minimally manipulated and re‑implanted for homologous use into the same patient during the same surgical procedure;

(v)	organs and tissues that are minimally manipulated and intended for transplant;

(vi)	reproductive cells (sperm, eggs) and embryos intended for assisted reproduction;

(vii)

whole blood and any blood component that is minimally manipulated and intended for treating blood loss or blood disorders.

(2)	For the purposes of paragraph (1) —

“homologous use” means the use of a cell, tissue or gene therapy product to repair, reconstruct, replace or supplement the cells or tissue of an individual (called the recipient) if the cell, tissue or gene therapy product performs the same basic function or functions in the recipient as the original cells or tissue in the donor in the same anatomical or histological environment;

“minimally manipulated”, in relation to a cell or tissue (but not a gene), means processing the cell or tissue by way of any process so that the biological characteristics or functions of the cell or the structural properties of the tissue (as the case may be) are not altered, such as by —

(a)	cutting or sizing;

(b)

grinding;

(c)

shaping;

(d)	centrifugation;

(e)	soaking in an antibiotic or antimicrobial solution;

(f)	sterilization or irradiation;

(g)	cell separation, concentration or purification;

(h)	filtration;

(i)	lyophilisation;

(j)

freezing;

(k)	cryopreservation; or

(l)	vitrification.

[S 564/2007; S 684/2007; S 438/2010; S 328/2016; S 320/2018; S 103/2021]

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