MEDICAL DEVICES PRODUCT CLASSIFICATION GUIDE

1 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.

2 ProductsfallingoutsidethescopeoftheMDreg ulatorycontrolsmaystillberegulated:-asHe althProductsunderotherProductCategories( suchasTherapeuticProduct,orCosmeticProdu cts)undertheHealthProductsAct,or-underot herlegislation( ,ConsumerProtection(FairTrading)Act,etc) .All Rights Reserved, Health Sciences Authority4 INTRODUCTIONMD Definition (First Schedule of HPA) 1) INTRODUCTIONO bjectiveDefinitionsIntended PurposeMEDICAL DEVICE means: a)Anyinstrument,apparatus,implement,mach ine,appliance,implant,reagentforinvitrou se,software,materialorothersimilarorrela tedarticlethatisintendedbyitsmanufacture rtobeused,whetheraloneorincombination,fo rhumansforoneormoreofthespecificpurposes of Diagnosis,prevention,monitoring,treatmen toralleviateofdisease; Diagnosis,monitoring,treatmentoralleviat ionof,orcompensationfor,aninjury.

3 Investigation,replacement,modificationor supportoftheanatomyorofaphysiologicalpro cess,mainlyformedicalpurposes; Supportingorsustaininglife; Controlofcontraception; Disinfectionofmedicaldevices;or Providinginformationbymeansofinvitroexam inationofspecimensderivedfromthehumanbod y,formedicalordiagnosticpurposes,andwhic hdoesnotachieveitsprimaryintendedactioni noronthehumanbodybypharmacological,immun ologicalormetabolicmeans,butwhichmaybeas sistedinitsintendedfunctionbysuchmeans;a ndb)Thefollowingarticles: Anyimplantforthemodificationorfixationof anybodypart; Anyinjectabledermalfillerormucousmembran efiller Anyinstrument,apparatus,implement,machin eorapplianceintendedtobeusedfortheremova lordegradationoffatbyinvasivemeansAll Rights Reserved, Health Sciences Authority5 INTRODUCTIONI ntended Purpose In order to determine whether a PRODUCT is considered a MEDICAL device, the following should be intended purpose of the PRODUCT taking into account the way the PRODUCT is designed and/or presented.

4 -If the intended purpose fits theMD definition in the First Schedule of Health Products Act (HPA), then it would be subject to control as a MEDICAL device in Singapore. primary mode of action by which the intended purpose is achieved. For a MEDICAL device, the primary mode of action by which the intended purpose is typically achieved is by physical means (including mechanical action, replacement of, or support of the anatomy or of a physiological process).1) INTRODUCTIONO bjectiveDefinitionsIntended PurposeAll Rights Reserved, Health Sciences Authority6 PRODUCTS WITH MEDICAL RELATED PURPOSEPERSONAL PROTECTIVE EQUIPMENT (PPE)PRODUCTS WITH MEDICAL RELATED PURPOSEGENERAL PURPOSE PRODUCTSASSISTIVE technology PRODUCTSPRODUCTS FOR SPORTS/PHYSICAL FITNESS/GENERAL HEALTH 1) STERILIZATION OR DISINFECTION2) CONTACT LENS CARE PRODUCTS3) PRODUCTS USED IN HOSPITAL/ LABORATORY5) SOLUTIONS OR MEDIA FOR TISSUES/CELLS 6) OTHERSPRODUCT(S)

5 CLASSIFICATIONREMARKSH andor skin antiseptic wipes, hand sanitizersNotMedical DeviceDisinfectantor Sterilantfor MEDICAL deviceMedical DeviceSterilization pouch specifically intended by its PRODUCT owner to be used together with the sterilizer for re-sterilizationof MEDICAL deviceMedical DeviceNote: 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 or disinfection 4) OPTHALMIC PRODUCTSAll Rights Reserved, Health Sciences Authority7 PRODUCT (S)

6 CLASSIFICATIONREMARKSR insing solutions for contact lensNotMedical DeviceCleaning solutions, EnzymeTablet, orLiquid for protein removal of contact lensNotMedical DeviceLenscare products for disinfectionof contact lens MedicalDevice Contact lens multipurpose solution(such as for cleaning, disinfecting, rinsing, and/or storing of contact lens)May be MEDICAL DeviceMultipurposesolutions with intended purposes that includes disinfectionor storageof contact lens will be classified as , Lubricating,orRewettingsolutions (to beinstil in the eyes while wearing contact lens) MEDICAL DeviceIntended for use to hydrate or lubricate, and to reduce friction between the lens and Lens Care ProductsPRODUCTS WITH MEDICAL RELATED PURPOSEPERSONAL PROTECTIVE EQUIPMENT (PPE)PRODUCTS WITH MEDICAL RELATED PURPOSEGENERAL PURPOSE PRODUCTSASSISTIVE technology PRODUCTSPRODUCTS FOR SPORTS/PHYSICAL FITNESS/GENERAL HEALTH 1) STERILIZATION OR DISINFECTION2) CONTACT LENS CARE PRODUCTS3) PRODUCTS USED IN HOSPITAL/ LABORATORY5) SOLUTIONS OR MEDIA FOR TISSUES/CELLS 6) OTHERS4) OPTHALMIC PRODUCTSAll Rights Reserved, Health Sciences Authority8 PRODUCT (S) CLASSIFICATIONREMARKSL aboratory equipmentfor.

7 -In-vitro diagnostic (IVD) use or-In-vitro fertilisation (IVF) MEDICAL DeviceExamples:-Incubators, centrifuges,or analysers for IVD use-IVFpipettes,transfer catheters or bags (empty)and blood bags (containing anticoagulant/preservatives) MEDICAL DeviceBlood refrigerator,or freezerMedical DeviceIntendedto preserve blood and blood products by storing them at cold or freezing temperature for eventual infusion/ MEDICAL Refrigerator(notintended for freezing or storing blood bags)Not MEDICAL Device Intended to store vaccines and other MEDICAL products at a stable temperature (prevent temperature fluctuations)

8 To ensure an ideal cold temperature storage for sensitive items due to quality issues and not Used in Hospital/LaboratoryPRODUCTS WITH MEDICAL RELATED PURPOSEPERSONAL PROTECTIVE EQUIPMENT (PPE)PRODUCTS WITH MEDICAL RELATED PURPOSEGENERAL PURPOSE PRODUCTSASSISTIVE technology PRODUCTSPRODUCTS FOR SPORTS/PHYSICAL FITNESS/GENERAL HEALTH 1) STERILIZATION OR DISINFECTION2) CONTACT LENS CARE PRODUCTS3) PRODUCTS USED IN HOSPITAL/ LABORATORY5) SOLUTIONS OR MEDIA FOR TISSUES/CELLS 6) OTHERS4) OPTHALMIC PRODUCTSAll Rights Reserved, Health Sciences Authority9 PRODUCT (S) CLASSIFICATIONREMARKSEye drops(primary mode of actionis physical: lubricating or physical washing) MEDICAL DeviceExamples: -Lubricatingor moisturizing eye drops for relief of dry,irritated eyes -Eye drops for relief of irritated eyes via physical washing of eye surface Eye bathor Eye wash(primarymode of action is physical.

9 Mechanical irrigation) MEDICAL DeviceAn example is the saline eye wash intended for irrigation of the eyes, during Products PRODUCTS WITH MEDICAL RELATED PURPOSEPERSONAL PROTECTIVE EQUIPMENT (PPE)PRODUCTS WITH MEDICAL RELATED PURPOSEGENERAL PURPOSE PRODUCTSASSISTIVE technology PRODUCTSPRODUCTS FOR SPORTS/PHYSICAL FITNESS/GENERAL HEALTH 1) STERILIZATION OR DISINFECTION2) CONTACT LENS CARE PRODUCTS3) PRODUCTS USED IN HOSPITAL/ LABORATORY5) SOLUTIONS OR MEDIA FOR TISSUES/CELLS 6) OTHERS4) OPTHALMIC PRODUCTSAll Rights Reserved, Health Sciences Authority10 PRODUCT (S) CLASSIFICATIONREMARKSF luorescein Ocular strips MEDICAL DeviceForevaluating the fit of contact lenses (works via staining of tear film).

10 Not MEDICAL DeviceIntended foruse to enhancevisualisation of anatomy for diagnostic purposesFluorescein eye dropNot MEDICAL DeviceIntended for use as diagnostic agent for eye conditionsand/or fitting of contact lens Ophthalmic Products PRODUCTS WITH MEDICAL RELATED PURPOSEPERSONAL PROTECTIVE EQUIPMENT (PPE)PRODUCTS WITH MEDICAL RELATED PURPOSEGENERAL PURPOSE PRODUCTSASSISTIVE technology PRODUCTSPRODUCTS FOR SPORTS/PHYSICAL FITNESS/GENERAL HEALTH 1) STERILIZATION OR DISINFECTION2) CONTACT LENS CARE PRODUCTS3) PRODUCTS USED IN HOSPITAL/ LABORATORY5) SOLUTIONS OR MEDIA FOR TISSUES/CELLS 6) OTHERS4) OPTHALMIC PRODUCTSAll Rights Reserved, Health Sciences Authority11 PRODUCT (S) CLASSIFICATIONREMARKSC ontactlens with corrective function (powered contact lens) MEDICAL DeviceNon-corrective contact lens (zero powered contact lens)Not MEDICAL DeviceDecorative lens with no corrective function, used to change the colour or appearance of the to Regulatory Guidelines For Devicesfor Modification of Appearance or Anatomy [1]Non-corrective contact lens labelled withmedical claimsMedical DeviceSome non-corrective contact lens may have a MEDICAL purpose, to treat a number of congenital or traumatic conditions.