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MEDICAL DEVICES PRODUCT CLASSIFICATION GUIDE

All Rights Reserved, Health Sciences Authority1 MEDICAL DEVICESPRODUCT CLASSIFICATIONGUIDE MEDICAL DEVICES ClusterMarch 2021 All Rights Reserved, Health Sciences (PPE)CONTENTS1) INTRODUCTIONO bjectiveDefinitionsIntended PurposeAll Rights Reserved, Health Sciences Authority3 INTRODUCTIONO bjective1) INTRODUCTIONO bjectiveDefinitionsIntended Purpose Medicaldevice(MD)isdefinedintheFirstSche duleoftheHealthProductsAct(HPA) ,forcertainproducts,itmaybechallengingto interpretwhetherornotitwouldbeclassified asaMD, Manyatimesitisincorrectlyassumedthatbeca useaproductisconsideredaMDinsomecountrie s, ,whendeterminingtheclassification. ProductsfallingoutsidethescopeoftheMDreg ulatorycontrolsmaystillberegulated:-asHe althProductsunderotherProductCategories( suchasTherapeuticProduct,orCosmeticProdu cts)undertheHealthProductsAct,or-underot herlegislation( ,ConsumerProtection(FairTrading)Act,etc) .

pharmacological, immunological or metabolic means, but which may be assisted in its intended function by such means; and b) The following articles: – Any implant for the modification or fixation of any body part; – Any injectable dermal filler or mucous membrane filler

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