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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) .

change the colour or appearance of the eyes. Refer to Regulatory Guidelines For Devices for Modification of Appearance or Anatomy [1] Non-corrective contact lens labelled with medical claims Medical Device Some non-corrective contact lens may have a medical purpose, to treat a number of congenital or traumatic conditions.

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