Is your product, intended by the manufacturer, to be used for human beings?
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, blood glucose meter)
Does your product achieve its primary intended action in or on the human body by pharmacological, immunological or metabolic means?
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)
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)
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)
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))
Is your product intended for the control of conception, including contraception? (Examples: Condoms, contraceptive intrauterine device (IUD))
Is your product intended for the disinfection or sterilisation of medical devices? (Examples: Contact lens solutions, denture disinfecting products, disinfectants)
Your product is unlikely to be a medical device under the Medical Device Administrative Control System.
Your product is a medical device under the Medical Device Administrative Control System.
You may proceed to the In Vitro Diagnostic Medical Device Classification Program to find out the risk class of your medical device.
You may also check the medical device and trader listing requirements for your medical devices if you already know its risk class.
You may proceed to the General Medical Device Classification Program to find out the risk class of your medical device.
The result of above Medical Device Administrative Control Systerm (MDACS) online tools are rough indications for references only. The developer and the web master of this page take no responsibility for the accuracy of the above online tool.