Registration in Israel – Amar – is for Medical Devices only ! How do we choose our products ? How do we know that our our products are indeed Medical Devices ? What is registered worldwide as Medical Devices , will be registered in Israel as Medical Devices!! A Medical Device (MD) A Medical Device is according to Directive (93/42/EEC) : Any instrument, apparatus, appliance, material or other article, whether used alone or in combination, including the software necessary for the proper application, intended by the manufacturer to be used for human beings for the purpose of diagnosis, prevention, monitoring, treatment or alleviation of disease,
diagnosis, monitoring, treatment, alleviation of or compensation for an injury or handicap,
investigation, replacement or modification of the anatomy or of a physiological process,
control of conception,
and which does not achieve its principal intended action in or on the human body by pharmacological, immunological or metabolic means, but which may be assisted by such means. Sometimes it is not clear whether a product is a medical device , or cosmetics : for example: Tooth paste, baby nappies etc.. in those specific cases it depends on manufacturer , they can be also be medical devices and not cosmetics In Vitro Diagnostic Medical Device (IVD)-Directive (98/79/EC) Any medical device which is a reagent, reagent product, calibrator etc. which are used in Labs,and are specifically intended by their manufacturer to be used for in vitro diagnostic examination. Active Implantable Medical Device (AIMD) - Directive (90/383/EEC L.S. Marketing & Registration www.ls-amarandmore.com
