Singapore legislation
Schedule 3
Schedule 3
Assignment of Medical Devices Into Classes
THIRD SCHEDULERegulation 24(1)Assignment of Medical Devices Into ClassesPart IClasses of Medical Devices
1. The classes of medical devices, listed in ascending order of the health risk posed to an end-user of a medical device assigned to the class, are as follows:
Class A (low risk);
Class B (moderately low risk);
Class C (moderately high risk); and
Class D (high risk).Part IIGENERAL CRITERIA FOR RISK CLASSIFICATION OF MEDICAL DEVICESDivision 1 — Medical devices other than in vitro diagnostic products
1. In this Division —“active diagnostic medical device” means an active medical device used, whether alone or in combination with any other medical device, to supply information for detecting, diagnosing or monitoring, or to provide support in the treatment of, any physiological condition, state of health, illness or congenital deformity;“active therapeutic medical device” means an active medical device used, whether alone or in combination with any other medical device, to support, modify, replace or restore biological functions or structures, with a view to the treatment or alleviation of any illness, injury or handicap;“CTGT product” means a health product categorised as a cell, tissue or gene therapy product in the First Schedule to the Act;[S 111/2021 wef 01/03/2021]“invasive medical device” means a medical device which, in whole or in part, penetrates inside a human body, either through a body orifice or through the surface of the body;“long‑term use”, in relation to a medical device, means continuous use of the medical device for a period exceeding 30 days;“non‑invasive medical device” means a medical device other than an invasive medical device;“short‑term use”, in relation to a medical device, means continuous use of the medical device for a period of between 60 minutes and 30 days;“surgically invasive medical device” means an invasive medical device which penetrates into the body —
through the surface of the body, with the aid or in the context of a surgical operation; or
other than through a body orifice;“transient use”, in relation to a medical device, means continuous use of the medical device for a period not exceeding 60 minutes.
2. The general criteria for risk classification of medical devices, other than in vitro diagnostic products, are —
the intended use, as identified by the product owner, of the medical device;
the level of risk posed to users and other persons by or in relation to the use of the medical device;
whether the medical device is an invasive medical device, a non‑invasive medical device or a surgically invasive medical device;
whether the medical device is for long-term use, short-term use or transient use;
whether or not the medical device is an active medical device;
where the medical device is an active medical device, whether the medical device is an active diagnostic medical device, active therapeutic medical device or active medical device used for administering or removing therapeutic products, CTGT products or medicinal products;[S 111/2021 wef 01/03/2021](g)whether the medical device incorporates, as an integral part, a substance that is liable to act on a human body with an action ancillary to that of the medical device, and the substance is —
a therapeutic product; or
a medicinal product subject to the licensing requirements of section 5 or 6 of the Medicines Act 1975;[S 434/2023 wef 31/12/2021](h)whether the medical device is manufactured from or incorporates any, or any combination of —
cells or tissues of animal origin; or
derivatives of cells or tissues of animal, human or recombinant origin,which are or have been rendered non-viable;[S 111/2021 wef 01/03/2021](i)whether the medical device is used for the sterilisation or disinfection of another medical device; and
whether the medical device is used for contraception or the prevention of the transmission of a sexually transmitted disease.Division 2 — In vitro diagnostic products
3. The general criteria for risk classification of medical devices that are in vitro diagnostic products are —
the intended use, as identified by the product owner, of the medical device;
the intended user, as identified by the product owner, of the medical device; and
the significance, in relation to the diagnosis or treatment of a patient or foetus or to public health, of the information provided by or derived from the use of the medical device.[S 318/2018 wef 01/06/2018]