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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.

ASSISTIVE TECHNOLOGY PRODUCTS FOR SPORTS/PHYSICAL FITNESS/GENERAL HEALTH 1) STERILIZATION OR DISINFECTION 2) CONTACT LENS CARE PRODUCTS 3) PRODUCTS USED IN HOSPITAL/ LABORATORY 5) SOLUTIONS OR MEDIA FOR TISSUES/CELLS 6) OTHERS PRODUCT(S) CLASSIFICATION REMARKS Hand or skin …

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  Guide, Technology, Assistive, Assistive technology

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