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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) .

medical device Medical Device Note: sterilization pouch used for the packaging and sterilization of a medical device prior to the supply of the device is part of the materials used in manufacturing process, and hence would not be classified as a Medical Device. Sterilization or disinfection 4) OPTHALMIC PRODUCTS

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