HSA published the document “Medical Devices Product Classification Guide” draft comments. This document aims to help the stakeholders in determining whether a product is a medical device or not.


Medical devices (MDs) are defined in the Health Products Act (HPA). Those products falling within the scope of such definition are regulated by the HSA. Some products, though, are harder to classify whether they are MDs or not. This draft has been published for the express purpose of clarifying such confusion.

If a product is classified as an MD in another country, it does not automatically mean that it would be the same in Singapore. Applicants should always consult the HPA for the definition for guidance. However, there are products that are not within the definition that may still be subjected to other regulations. This includes Other Product Categories under the HPA, or under other legislations (such as Radiation Protection Act, Consumer Protection/Fair Trading Act, etc.).

As a recap, the definition of an MD is: 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

  • - Diagnosis, prevention, monitoring, treatment or alleviate of disease;
  • - Diagnosis, monitoring, treatment or alleviation of, or compensation for, an injury;
  • - Investigation, replacement, modification or support of the anatomy or of a physiological process, mainly for medical purposes;
  • - Supporting or sustaining life;
  • - Control of contraception;
  • - Disinfection of medical devices; or
  • - 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.
  • MDs may also refer to the following articles:

  • - Any implant for the modification or fixation of any body part;
  • - Any injectable dermal filler or mucous membrane filler
  • - Any instrument, apparatus, implement, machine or appliance intended to be used for the removal or degradation of fat by invasive means
  • In order to correctly identify if a product is an MD, its intended use must be considered, as well as its design and presentation. In addition, the primary mode of action of the product must also be taken into account.

    Products with Medical – Related Purpose

    Products, whose purpose can be considered as medical but not explicitly stated as medical device, fall into this category. This includes:

  • - Products for sterilization or disinfection
    • Hand or skin antiseptic wipes, hand sanitizers – NOT MDs
    • Disinfectant or sterilant for MDs – MD
    • Sterilization pouch (for use together with sterilizer) – MD
  • - Products for contact lens care
    • Rinsing solution – NOT MD
    • Cleaning solution, enzyme tablet, liquid for protein removal – NOT MDs
    • Disinfectant lens care – MD
    • Multipurpose solution – MAYBE MD
    • Hydrating, lubricating, or rewetting solutions – MDs
  • - Products used in hospitals/laboratories
    • Lab equipment for in vitro diagnostic (IVD) or in vitro fertilization (IVF) – MDs
    • Blood bags (empty or containing anticoagulants/preservatives) – MDs
    • Blood refrigerator or freezer – MD
    • Vaccine/pharmaceutical/medical refrigerator – NOT MDs
  • - Ophthalmic products
    • Eye drops – MDs
    • Eye bath or wash – MDs
    • Fluorescein ocular strips – MD (for contact lens fit evaluation),
    • Fluorescein ocular strips – NOT MD (enhancement of visualization of anatomy for diagnosis)
    • Fluorescein eye drop – NOT MD
    • Contact lens – MD (for correction), NOT MD (non – corrective), MD (non – corrective with medical claims).
  • - Solutions/media for tissues/cells
    • Cell culture media – NOT MD
    • Organ preservation solution – NOT MD
    • IVF media – MD
    • IVD culture media – MD


    • Cold laser therapy – MD
    • Liposuction machine – MD
    • Sitz bath – MD
    • Medical gases – NOT MDs
    • Acupuncture needles, electroacupuncture machines – MDs
    • Dental aligners and retainers – MDs
    • In vivo diagnostic agents – NOT MD
    • Hot or cold packs/water bottles, heat pads – MDs (for pain relief), NOT MDs (intended purpose excludes them from being MDs)
    • Peritoneal dialysis solution – NOT MD
    • Hemofiltration solution – NOT MD
    • Haemodialysis solution – MD
    • Pressure regulator for medical gases – MDs
    • Female intimate hygiene products – NOT MDs
    • Lubricants – MDs (with medical purpose), NOT MDs (with no medical purpose)
    1. General Purpose Products

    2. Products, with multiple purposes with occasional applications in the medical setting, are NOT MDs unless otherwise stated in their specific intended purpose. This includes:

      • Air decontamination/purification units
      • Multipurpose general disinfectant
      • Multipurpose computer and printer
      • Toothbrush, toothpaste, mouthwash, dental floss
      • Denture cleansing tablets
      • Dental disclosing solution/tablets
      • Tooth whitening or bleaching products
      • Female hygiene products
      • Diapers
      • Commodes and bedpans
      • Gallipots, kidney dishes
      • Breast pumps
      • Sunscreens
      • Insect/mosquito repellent/patches
      • Lice comb
      • Medicine spoons/droppers. Dispensers/storage for pills, capsules, and tablets
      • Laser equipment (for non – invasive lipolysis)
      • Needles for tattooing
      • Microneedles or dermal rollers
      • Brushes or sponges for washing and/or cleaning of nails and/or hands
      • Pipelines/manifolds in hospitals
      • Ceiling pendants, fixed installations, treatment rooms in hospitals
      • General laboratory equipment
      1. Assistive Technology Products
      2. Products used to alleviate or compensate for disability. They help disabled individuals overcome difficulties in their daily activities. The determining factors in classifying such products are: link between the corrective function of the product with the disability of the individual, and the indicated medical purpose. This includes:

      • Wheelchair – MD
      • Walking stick – MD
      • Hearing aid – MD
      • Prosthetic devices – MDs
      • Alarm system at home – NOT MD
      • Toilet equipment for the disabled – NOT MD
      • Grab rails at doorways or stairs – NOT MDs
      • Portable ramps – NOT MDs
      1. Products for Sports/Physical Fitness/General Health

        Products used in sports, leisure, and physical fitness. This includes.

      • Gym equipment or watch with heart rate monitoring function – MAYBE MD
      • Foot patch for well – being – NOT MD
      • Bandages or support for injuries – MDs
      1. Personal Protective Equipment (PPE)

        These are products that are worn for protection from hazards. The determining factor is whether the product is used for healthcare or for medical purpose. This includes:

      • Gloves or gowns not for medical purposes – NOT MD
      • Medical examination/surgical gloves, surgical/isolation gowns – MDs
      • Face mask/N95 respirator for non – medical purpose – NOT MD
      • Medical/surgical face masks and N95 respirators – MDs
      • Mouth guards for non – medical device purposes – NOT MDs



Consultation on Medical Devices Product Classification Guide

Medical Devices Product Classification Guide