PART I | Citation and commencement |
| 1. These Regulations may be cited as the Health Products (Medical Devices) Regulations 2010 and shall come into operation on 10th August 2010. |
2. In these Regulations, unless the context otherwise requires —“active implantable medical device” means any active medical device that is intended by its product owner —| (a) | to be introduced, either —| (i) | by surgical or medical intervention, wholly or partially into the body of a human being; or | | (ii) | by medical intervention, into a body orifice; and |
| | (b) | to remain in place after the procedure; |
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“active medical device” means any medical device —| (a) | the operation of which depends on a source of electrical energy or any source of power other than that directly generated by a human body or gravity; and | | (b) | which acts by converting that energy, |
| but does not include any medical device intended to transmit any energy, substance or other element between that medical device and a patient without any significant change to that energy, substance or element; |
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| “Authority’s website” means the Authority’s Internet website at http://www.hsa.gov.sg; [S 334/2016 wef 01/11/2016] |
| “body orifice” means any natural opening in a human body, the external surface of any eyeball, or any permanent artificial opening, such as a stoma or permanent tracheotomy; |
| “clinical purpose” means any of the specific purposes described in paragraph (a) of the definition of “Medical device” in the second column of item 1 of the First Schedule to the Act; [S 334/2016 wef 01/11/2016] [S 318/2018 wef 01/06/2018] |
| “clinical research” has the same meaning as in regulation 2(1) of the Health Products (Therapeutic Products as Clinical Research Materials) Regulations 2016 (G.N. No. S 332/2016); [S 334/2016 wef 01/11/2016] |
“custom-made medical device” means a medical device that —| (a) | is made at the request of a qualified practitioner and in accordance with the specifications of the qualified practitioner regarding the design characteristics or construction of the medical device; | | (b) | is intended to be used only in relation to a particular individual; and | | (c) | is not adapted from a mass-produced medical device; |
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“field safety corrective action” means any action taken to reduce the risk of death or serious deterioration in the state of health of a person associated with the use of a medical device, including —| (a) | the return of the medical device to its product owner; | | (b) | the replacement or destruction of the medical device; | | (c) | any action regarding the use of the medical device that is taken in accordance with the advice of its product owner; | | (d) | the clinical management of any patient who has used the medical device; | | (e) | the modification of the medical device; | | (f) | the retrofitting of the medical device in accordance with any modification to it or any change to its design by its product owner; | | (g) | the making of any permanent or temporary change to the labelling or instructions for use of the medical device; or | | (h) | any upgrade to any software used with the medical device, including any such upgrade carried out by remote access; |
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“Good Distribution Practice Standard for Medical Devices” means any of the following:| (a) | before 9 November 2020, the Authority’s Good Distribution Practice for Medical Devices — Requirements (TS‑01) as published on the Authority’s website; | | (b) | the Singapore Standard for Good Distribution Practice for Medical Devices — Requirements (SS 620); | | (c) | any other good distribution practice standard for medical devices that is approved by the Authority and is specified on the Authority’s website; [S 318/2018 wef 01/06/2018] |
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| “harm” means any physical injury or damage to the health of a person, or any damage to property or the environment; |
| “hazard” means any potential source of harm; |
“implantable medical device” means any medical device which is intended by its product owner —| (a) | to be wholly introduced into a human body, or to replace a human epithelial surface or the surface of a human eye, by surgical intervention, and to remain in place after the surgical intervention; or | | (b) | to be partially introduced into a human body by surgical intervention, and to remain in place for at least 30 days after the surgical intervention, |
| and includes any such medical device that is wholly or partially absorbed by the human body, epithelial surface or eye; |
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“in vitro diagnostic product” —| (a) | means any reagent, reagent product, calibrator, control material, kit, instrument, apparatus, equipment or system, whether used alone or in combination with any other reagent, reagent product, calibrator, control material, kit, instrument, apparatus, equipment or system, that is intended by its product owner to be used in vitro for the examination of any specimen, including any blood or tissue donation, derived from the human body, solely or principally for the purpose of providing information —| (i) | concerning a physiological or pathological state or a congenital abnormality; | | (ii) | to determine the safety and compatibility of any blood or tissue donation with a potential recipient thereof; or | | (iii) | to monitor therapeutic measures; and |
| | (b) | includes a specimen receptacle; |
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“institutional review board” means an independent body which —| (a) | is constituted of medical, scientific, and non‑scientific members, whose responsibility is to ensure the protection of the rights, safety and wellbeing of subjects by, among other things, reviewing, approving and providing continuing review of the protocol, amendments, and the methods and materials to be used in obtaining and documenting informed consent of the subjects; and | | (b) | when Part 4 of the Human Biomedical Research Act 2015 comes into operation, is appointed under that Act; [S 334/2016 wef 01/11/2016] [S 434/2023 wef 31/12/2021] |
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| “intended use” or “intended purpose”, in relation to a medical device or its process or service, means the objective intended use or purpose, as the case may be, of the medical device, process or service, as reflected in the specifications, instructions and information provided by the product owner of the medical device; |
| “ISO 13485” means the 2003 or 2016 edition of the publication ISO 13485, Medical Devices — Quality Management Systems — Requirements for Regulatory Purposes, published by the International Organization for Standardization; [S 318/2018 wef 01/06/2018] |
“laboratory‑developed test” means a medical device in the form of an in vitro assay or test for clinical diagnostic use that is —| (a) | manufactured based on basic scientific principles; or | | (b) | developed or manufactured based on reputable scientific sources, |
| but excludes a medical device that is modified or adapted from an in vitro assay or test manufactured or supplied by another person; |
[S 318/2018 wef 01/06/2018] |
| “licensee” means a holder of any licence issued by the Authority under the Act; |
| “medical device” means a medical device referred to in the First Schedule to the Act; |
| “medicinal product” has the same meaning as in section 3 of the Medicines Act 1975; [S 434/2023 wef 31/12/2021] |
| “non-viable”, in relation to a biological entity, means that the entity is incapable of growth, development and reproduction; |
| “objective evidence” means information that can be proved to be true, based on facts obtained through observation, measurement, testing or any other means; |
“product owner”, in relation to a health product, means a person who —| (a) | supplies the health product under his own name, or under any trade mark, design, trade name or other name or mark owned or controlled by him; and | | (b) | is responsible for designing, manufacturing, assembling, processing, labelling, packaging, refurbishing or modifying the health product, or for assigning to it a purpose, whether those tasks are performed by him or on his behalf; |
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| ““professional use only” medical device” means a medical device that is to be used on an individual solely by, or under the supervision of, a qualified practitioner; |
“qualified practitioner” means —| (a) | a registered medical practitioner under the Medical Registration Act 1997, when acting in the course of providing medical treatment to a patient under his care; or [S 434/2023 wef 31/12/2021] | | (b) | a registered dentist under the Dental Registration Act (Cap. 76) whose name appears in the first division of the Register of Dentists maintained and kept under section 13(1)(a) of that Act, when acting in the course of providing dental treatment to a patient under his care; |
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| [Deleted by S 318/2018 wef 01/06/2018] |
| “registered midwife” has the same meaning as in section 2 of the Nurses and Midwives Act 1999; [S 434/2023 wef 31/12/2021] |
| “registered nurse” has the same meaning as in section 2 of the Nurses and Midwives Act 1999; [S 434/2023 wef 31/12/2021] |
| “registered pharmacist” has the same meaning as in section 2 of the Pharmacists Registration Act 2007; [S 434/2023 wef 31/12/2021] |
“regulated clinical trial” means any clinical research that is —| (a) | authorised by the Authority, or notified to the Authority and the notification accepted by the Authority, under regulation 8 or 9 of the Health Products (Clinical Trials) Regulations 2016 (G.N. No. S 331/2016); or | | (b) | issued with a certificate under regulation 8 of the Medicines (Clinical Trials) Regulations 2016 (G.N. No. S 335/2016); [S 334/2016 wef 01/11/2016] |
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| “risk” means a combination of the probability of occurrence of harm and the severity of that harm; |
“serious deterioration in the state of health”, in relation to a person, means —| (a) | a life-threatening illness or injury suffered by that person; | | (b) | a permanent impairment of a bodily function of that person; | | (c) | any permanent damage to any part of that person’s body; or | | (d) | a condition requiring medical or surgical intervention to prevent any such permanent impairment or damage; |
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“specimen” means a discrete portion of a body fluid or tissue, or of any other sample associated with a human body, which is taken for —| (a) | examination; | | (b) | study; or | | (c) | analysis of one or more quantities or characteristics, in order to determine the character of the whole; |
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| “specimen receptacle” means any receptacle, whether vacuum-type or not, intended by its product owner to be used for the primary containment of any specimen derived from a human body; |
| “sponsor” means a person who takes responsibility for the initiation, management or financing of any clinical research; [S 334/2016 wef 01/11/2016] |
| “sterile state”, in relation to a medical device, means a state free of viable micro-organisms; [S 169/2012 wef 01/05/2012] |
| “therapeutic product” means a health product categorised as a therapeutic product in the First Schedule to the Act; [S 538/2016 wef 01/11/2016] |
“trade description” means any description, statement or indication which, directly or indirectly and by whatever means given, relates to any of the following matters in respect of a medical device:| (a) | the quantity, length, width, height, area, volume, capacity or weight of the medical device; | | (b) | the method of manufacture, production, processing, modification, refurbishment or reconditioning of the medical device; | | (c) | the components or composition of the medical device; | | (d) | the fitness for purpose (including expiry date), strength, performance, behaviour or accuracy of the medical device; | | (e) | any physical or other characteristics of the medical device not referred to in paragraphs (a) to (d); | | (f) | the testing of the medical device by any person and the results thereof; | | (g) | the approval of the medical device by any person or its conformity with a description or class of medical devices approved by any person; | | (h) | the place or date of the manufacture, production, processing, modification, refurbishment or reconditioning of the medical device; | | (i) | the name of the person who manufactured, produced, processed, modified, refurbished or reconditioned the medical device; | | (j) | any other history, including any history of previous ownership or use, of the medical device; [S 318/2018 wef 01/06/2018] |
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| ““trained user only” medical device” means a medical device that is to be used only by an individual who has undergone such training on the safe and efficacious use of the medical device as is necessary. [S 318/2018 wef 01/06/2018] |
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