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1. Introduction

Objective Intended Purpose •Medical device (MD) is defined in the First Schedule of the Health Products Act (HPA) and products that meet this definition are regulated as MDs by HSA. However, for certain products, it may be challenging to interpret whether or not it would be classified as an MD, within the scope of the MD definition. This document has been developed to aid with classification of some of these more challenging products. •Many a time it is incorrectly assumed that because a product is considered an MD in some countries, it will also be an MD in Singapore. This is not the case and the definition of MD should always be consulted, when determining the classification. •ProductsfallingoutsidethescopeoftheMDregulatorycontrolsmaystillbea regulatedproduct: -asHealthProductsunderotherProductCategories(suchasTherapeutic Product,orCosmeticProducts)undertheHealthProductsAct,or -underotherlegislation(e.g.RadiationProtectionAct,ConsumerProtection(Fair Trading)Act,etc). Objective Intended Purpose •Medical device (MD) is defined in the First Schedule of the Health Products Act (HPA) and products that meet this definition are regulated as MDs by HSA. However, for certain products, it may be challenging to interpret whether or not it would be classified as an MD, within the scope of the MD definition. This document has been developed to aid with classification of some of these more challenging products. •Many a time it is incorrectly assumed that because a product is considered an MD in some countries, it will also be an MD in Singapore. This is not the case and the definition of MD should always be consulted, when determining the classification. •ProductsfallingoutsidethescopeoftheMDregulatorycontrolsmaystillbea regulatedproduct: -asHealthProductsunderotherProductCategories(suchasTherapeutic Product,orCosmeticProducts)undertheHealthProductsAct,or -underotherlegislation(e.g.RadiationProtectionAct,ConsumerProtection(Fair Trading)Act,etc). MD Definition (First Schedule of HPA) Intended Purpose •In order to determine whether a product is considered an MD, the following should be considered: A.The intended purpose of the product taking into account the way the product is designed and/or presented. -If the intended purpose fits the MD definition in the First Schedule of Health Products Act (HPA), then it would be subject to control as a medical device in Singapore. B.The primary mode of action by which the intended purpose is achieved. –For a medical device, the primary mode of action by which the intended purpose is typically achieved is by physical means (including mechanical action, replacement of, or support of the anatomy or of a physiological process). Intended Purpose

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2. Products with Medical Related Purpose

PRODUCT(S) CLASSIFICATION REMARKS Handor skin antiseptic wipes, hand sanitisers NotMedical Device Disinfectantor Sterilantfor medical device Medical Device Sterilisation pouch specifically intended by its product owner to be used together with the steriliser for re-sterilisationof medical device Medical Device Note: sterilisation pouch used for the packaging and sterilisation of a medical device prior to the supply of the device is part of the materials used in manufacturing process, and hence would not be classified as a Medical Device. Sterilisation or disinfection PRODUCT(S) CLASSIFICATION REMARKS Rinsing solutions for contact lensNot Medical Device Cleaning solutions, Enzyme Tablet, or Liquid for protein removal of contact lens Not Medical Device Contact lens multipurpose solution (such as for cleaning, disinfecting, rinsing, and/or storing of contact lens) May be Medical Device Multipurpose solutions with intended purposes that includes disinfection or storage of contact lens will be classified as MD. Hydrating, Lubricating, or Rewetting solutions (to be instil in the eyes while wearing contact lens) Medical Device Intended for use to hydrate or lubricate, and to reduce friction between the lens and eyes. Contact Lens Care Products PRODUCT(S) CLASSIFICATION REMARKS Laboratory equipmentfor: -In vitro diagnostic (IVD) use or -In vitro fertilisation (IVF) Medical Device Examples: -Incubators, centrifuges,or analysers for IVD use -IVFpipettes,transfer catheters or needles. Blood bags (empty) and blood bags (containing anticoagulant/preservatives) Medical Device Products Used in Hospital/Laboratory PRODUCT(S) CLASSIFICATION REMARKS Blood refrigerator,or freezer Medical Device Intendedto preserve blood and blood products by storing them at cold or freezing temperature for eventual infusion/ transfusion. Vaccine/Pharmaceutical/ Medical Refrigerator (not intended for freezing or storing blood bags) Not Medical Device Intended to store vaccines and other medical products at a stable temperature (prevent temperature fluctuations) to ensure an ideal cold temperature storage for sensitive items due to quality issues and not degrade. Products Used in Hospital/Laboratory PRODUCT(S) CLASSIFICATION REMARKS R2 ► Eye dropsor eye irrigation solution (primary mode of actionis physical: lubricating or physical washing) Medical Device Examples: -Lubricatingor moisturising eye drops for relief of dry,irritated eyes -Eye drops or irrigation solutionfor relief of irritated eyes (due to particles such as dust or smoke) via physical washing of eye surface Eye drops (primary mode of action via osmosis) Not Medical Device An example is eye drops intended for temporary relief of corneal edema. Emergency eye washes Not Medical Device Emergency eye washes intended solely for washing of chemical spills/ splash. ◄ Ophthalmic Products PRODUCT(S) CLASSIFICATION REMARKS Fluorescein Ocular strips Medical Device Forevaluating the fit of contact lenses (works via staining of tear film). Not Medical Device Intended for use to enhance visualisation of anatomy for diagnostic purposes. Fluorescein eye drop Not Medical Device Intended for use as diagnostic agent for eye conditions and/or fitting of contact lens. Ophthalmic Products PRODUCT(S) CLASSIFICATION REMARKS Contact lens with corrective function (powered contact lens) Medical Device Non-corrective contact lens (zero powered contact lens) Not Medical Device Decorative lens with no corrective function, used to change the colour or appearance of the eyes. Refer to Regulatory Guidelines For Devicesfor Modification of Appearance or Anatomy [1] Non-corrective contact lens labelled with medical claims Medical Device Some non-corrective contact lens may have a medical purpose, to treat a number of congenital or traumatic conditions. Anexampleis UV blocking contact lenses which claims to protect against transmission of harmful UV radiation to the cornea and into the eye, to alleviate photophobia in albinism. Ophthalmic Products PRODUCT(S) CLASSIFICATION REMARKS Cellculture media for cell or tissue therapy Not Medical Device Considered as processing reagents. Organ preservation solution Not Medical Device Comparableto processing reagents.An example is solution for preserving of corneal material prior transplant. Solutions/Media for Tissues/Cells PRODUCT(S) CLASSIFICATION REMARKS In vitro fertilisation (IVF) media for: •Sperm preparation •Follicle Aspiration •Rinsing •Fertilisation •Embryo Culture •Embryo Transfer Medical Device Replacement or modification of a physiological process. In vitrodiagnostic (IVD) culture mediaMedical Device Labelled for IVD use. For definition of IVD product, please refer to Guidance on Risk Classification of IVD Medical Devices (GN-14) [2]. Solutions/Media for Tissues/Cells PRODUCT(S) CLASSIFICATION REMARKS Cold laser therapy (for pain management and/or to accelerate healing) Medical device Liposuction Machine Medical Device Intended to remove fats from the body using suction (by invasive means). Refer to Regulatory Guidelines For Devices for Modification of Appearance or Anatomy [1] SitzbathMedical DeviceGenerallyintendedfor pain relief. Medical gases such as oxygen for breathing and anaesthetic gases (supplied in cylinders) Not Medical Device Others PRODUCT(S) CLASSIFICATION REMARKS R2 ► Emergency skin washes Not Medical Device Emergency skin washes intended solely for washing of chemical spills/ splash ◄ Acupuncture Needles, Electro- acupuncture machines Medical Device Dental aligners, Dentalretainers for use after orthodontic treatment Medical Device In vivo diagnostic agents such as x-ray contrast media and gases for lung function test Not Medical Device Others PRODUCT(S) CLASSIFICATION REMARKS Hotor cold packs, Heat pads, Hotor cold water bottles Medical DeviceGenerallyintendedfor pain relief. Not Medical Device Labelledwith specific intended purpose to excludethese products from being amedical device. An example is heat pads labelledfor keeping warmth incold weather. Others PRODUCT(S) CLASSIFICATION REMARKS Peritoneal dialysis solutionNot Medical Device Hemofiltration solution Not Medical Device Note: It is a replacement/substitution solution used in renal replacement therapy, where the exchangeof solutes is by convection (hemofiltration). Haemodialysis solution Medical Device Note: Exchangeof solutes is by diffusion, across a semi-permeable membrane. Others PRODUCT(S) CLASSIFICATION REMARKS Pressure or gas regulators for medical gases (to control flow rate) Medical Device Female intimate hygiene products (primary mode of action is via restoration of vaginal pH) Not Medical Device An example is douche or gel intended to restore natural pH in vagina, for symptomatic relief of vaginal irritation, or infections. Others PRODUCT(S) CLASSIFICATION REMARKS Lubricants Medical Device Lubricants with a medical purpose. Examples: -Lubricant for use in medical procedures with medical devices such as endoscopes. -Lubricant intended for use with condoms (medical device) to facilitate the function of condom -Vaginal lubricant intended for a medical purpose such as for treatment of vaginal dryness. Not Medical Device Personallubricants thatis intended for a non-medical purpose (e.g. sexual comfort/ for pleasure). Note: Personal lubricants which claims compatibility to condom (e.g. can be used with condom) are not medical device as it is only to indicate the fact that it can be safely used in combination with (latex) condom. Such personal lubricants compatible for use with condoms (ie. latex) are not medical devices. Others

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3. General Purpose Products

PRODUCT(S) CLASSIFICATION REMARKS Air Decontaminationor Purification Units NotMedical Device Products intended to remove allergens (dust, pollen, etc) and/or to remove bacteria from the air in a specific area/room. They may be used in hospitals for air decontamination, aiming to reduce infection risks in intensive care units and operating theatres. Not for disinfection of medical devices. Multipurpose general disinfectant Not Medical Device These products are intended for disinfecting various surfaces such as floors, walls and sanitary facilities. Not for disinfection of medical devices. Multipurpose computer and printer Not Medical Device These products are not medical devices unless they are specifically intended*to be used in combination with a medical device as an accessory. Products that serves multiple purposes may occasionally be used within a medical setting. These are notconsidered medical devices, unlessthe product is intended for a specific medical purpose. *Specifically intended refers to a clear indication of such use in the information accompanying the medical device. PRODUCT(S) CLASSIFICATION REMARKS Toothbrush, Toothpaste, Mouthwash, Dental floss Not Medical Device Primarily intended for basic oral hygiene and/or cleaning. Denture cleansing tabletsNot Medical Device Dental disclosing solution/tablets Not Medical DeviceGenerally used to disclose dental plaques on teeth. Tooth whitening or bleaching products (Instruments and gel) Not Medical Device Tooth whitening instruments: refer to Regulatory Guideline for Devices for Modification of Appearance or Anatomy [1] PRODUCT(S) CLASSIFICATION REMARKS Female hygiene products such as: Tampons, Menstrual Cup, Pads/sanitary towel Not Medical Device Diapers (for baby and/ or adults)and Incontinence pads Not Medical Device Generally used to containorabsorb urine and waste. Commodesand Bedpans(Body waste receptacles) Not Medical Device Generally usedto contain body waste. Gallipots, Kidney dishes Not Medical Device Generally intended for a variety of purposes such as containing fluids, mixing solutions, carrying or holding instruments prior to or during a procedure, and collecting body waste or other matters. PRODUCT(S) CLASSIFICATION REMARKS Breast pumps Not Medical Device Generally, breast pumps are intended for milk extraction. Sunscreens Not Medical Device Insect repellent, Mosquito repellent or patches Not Medical Device Lice comb Not Medical Device For removal of lice and lice eggs from human hair Medicine spoons, Medicine droppers, Dispensersor Storage containers for pills, capsules and tablets Not Medical Device PRODUCT(S) CLASSIFICATION REMARKS Laser equipment (for non-invasivelipolysis) Not Medical Device Intended to remove fats from the body (by non-invasive means). Refer to Regulatory Guidelines For Devicesfor Modification of Appearance or Anatomy [1] Needles for tattooing Not Medical Device Refer to Regulatory Guidelines For Devicesfor Modification of Appearance or Anatomy [1] Microneedles or dermal rollers (to create micro punctures on the skin) for skin rejuvenation or for scars Not Medical Device Refer to Regulatory Guidelines For Devicesfor Modification of Appearance or Anatomy [1] Brushes,or Sponges for washingand/or cleaning of nails and/or hands Not Medical Device An example is brush or sponge foruse by healthcare professionals prior surgery (on intact skin not relating to wound care), for cleaning of nails and/or hands. Generally, infrastructures are not medical devices. However, if the fixtures include examination lights or gas flow control function (of medical gases) etc., please contact the Medical Devices Cluster with product information. General Laboratory Equipment Not Medical Device General lab equipment not for in vitrodiagnostic use are not regulated as Medical Devices. For definition of in vitro diagnostic (IVD) devices, please refer to Guidance on Risk Classification of IVD Medical Devices (GN-14) [2].

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4. Assistive Technology Products

Assistive technology products are generally intended for alleviation of, orcompensation for disability. They are designed to help individual with disability to overcome barriers they face in carrying out their daily living activities. Depending on the primary intended purpose, these products may be considered either medical devices or general consumer products. The main determining factor will be whether there is a: (a) direct link between the corrective function of the product and the individual with disabilityand, (b) that there is a stated medical purpose MEDICAL DEVICESNOTMEDICAL DEVICES WheelchairAlarm system in toilets/homes Walking stickToilet equipment for disabled Hearing AidGrab rails at doorways or stairs Prosthetic DevicesPortable ramps

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5. Products for Sports/Physical Fitness/General Health

/GENERAL HEALTH In general, products intended for sport or leisure purposes are not considered as medical devices. Similarly, products intended for physical fitness, maintenance of general state of health (ie. weight management, recreational use, sleep management, detoxification, improving and enhancing flow of (qi) are not considered medical devices. PRODUCT(S) CLASSIFICATION REMARKS Gym equipment or Watch with a function to measure heart rate May or May not be a Medical Device Refer to Regulatory Guidelines for Telehealth Products [3] for determination of product classification. Foot patch intended to maintain good health,promote good sleep, to soothe or relax muscle NotMedical Device Bandagesorsupport for sprains or injuries Medical Device

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6. Personal Protective Equipment (PPE)

•PPE are products that are generally worn to protect users from workplace hazards. •The primary determining factor will be whether the product is for use in a healthcare setting, or for a medical purpose. PRODUCT(S) CLASSIFICATION REMARKS Gloves or gowns for non- medical purposesNot Medical Device Gloves or gowns intended for other purposes (outside of healthcare settings) such as food industry would not be considered as medical device. Medical/ Examination/ Surgical gloves, Surgical/Isolation gowns Medical Device Glovesorgownsintendedtobewornbyhealthcare personnelduringmedical/surgicalproceduresfor theprotectionof: •healthcareprofessional •patientwhomaycontractillnessesormedical conditionsfrombeingexposedtopotentially infectiousbacteria PRODUCT(S) CLASSIFICATION REMARKS Facemask/N95 respirator for non-medical purposes Not Medical Device Facemask/ N95 respirator labelled solelyfor occupational uses would not be a medical device. Medical/ SurgicalFacemasks and N95 RespiratorsMedical Device Medical/ surgical facemasks and N95 respirators intended for use in healthcare settings. Mouth guards for non-medical purposes Not Medical Device Mouth guards intended for sports purposes.