Is Your Product A Medical Device?

Is Your Product A Medical Device?

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Q1

Is your product, intended by the manufacturer, to be used for human beings?

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Qa

Is your product intended to provide information for medical purposes by means of in vitro examination of specimens derived from the human body? (Examples: Pregnancy test kits, urine test strips)

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Does your product achieve its primary intended action in or on the human body by pharmacological, immunological or metabolic means?

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Is your product intended for the diagnosis, prevention, monitoring, treatment or alleviation of any disease? (Examples: Thermometers, blood pressure monitors and cuffs, radiological imaging software, hearing aids, pacemakers)

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Is your product intended for the diagnosis, monitoring, treatment, alleviation of or compensation for an injury? (Examples: Ultrasound for physiotherapy, wound dressings/plasters, wheelchairs/walking sticks, sutures)

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Is your product intended for the investigation, replacement, modification, or support of the anatomy, or of a physiological (healthy or normal functioning of the body) process? (Examples: Breast implants, gluteal implants, collagen/hyaluronic dermal fillers, invasive lipolysis equipment, heart valve, prosthetic limbs, dermal fillers)

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Is your product intended for supporting or sustaining life? (Examples: Dialysis machine, ventilators and related accessories such as masks and tubings, ventricular assist devices (VAD))

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Is your product intended for the control of conception, including contraception? (Examples: Condoms, contraceptive intrauterine device (IUD))

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Q2b

Is your product intended for the disinfection or sterilisation of medical devices? (Examples: Contact lens solutions, denture disinfecting products, disinfectants)

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Disclaimer

The above classification program are rough indications for references only. The actual classification of the medical devices is subject to the provision of the Medical Device Administrative Control Systerm (MDACS) which may be updated from time to time. The programme designer and the manager of this page take no responsibility for the accuracy of the above classification program.