PRODUCT INSTRUCTION MANUAL TEMPLATE-东南亚（东盟）市场专用版（2026版）

PRODUCTINSTRUCTIONMANUALTEMPLATE——东南亚（东盟）市场专用版（2026版）产品说明书模板(ApplicabletoPharmaceuticalProducts/MedicalDevices/ConsumerGoods/HouseholdAppliances/ElectronicProducts)（适用于药品/医疗器械/消费品/家用电器/电子产品）ForSoutheastAsia(ASEAN)Markets(2026Edition)|东南亚（东盟）市场专用版（2026版）编制说明/PreparationNote:本模板严格遵循东南亚国家联盟医疗器械指令（AMDD）AnnexI安全与性能基本原则（EPSP）关于标签和说明书的要求，依据东盟通用提交档案模板（CSDT）框架编制（CSDT涵盖产品标签、包装材料和完整说明书内容）。标签及说明书语言须为目标市场国家官方语言，各国语言要求如下：印尼须用印尼语（BahasaIndonesia）并可附加英文；泰国自2026年6月20日起家用器械须用泰语、专业用器械可为泰语或英语；越南依第37/2026/ND-CP号法令规定须用越南语并可附加其他语言；菲律宾须用英语或菲律宾语；马来西亚须用英语、家用器械须附加马来语（BahasaMalaysia）；新加坡须用英语。东盟消费者保护委员会（ACCP）于2026年4月16日发布《东盟产品安全标签指南》（ASEANGuidelinesonProductSafetyLabelling），要求在标签上提供安全使用、搬运和处置等基本警示信息。Header/页眉:XXCompanyProductIFUTemplate—ForReferenceOnly,2026Edition|ASEANMarketsVersionFooter/页脚:版本号:V3.0|编制日期:2026年XX月XX日|页码:第X页/共Y页|DocumentRef.:ASEAN-IFU-2026FormatRequirements/格式要求:A4papersize,Englishasprimarylanguagewithlocallanguage(BahasaIndonesia/Thai/Vietnamese/Filipino/BahasaMalaysia)asrequiredbytargetcountry.Bodytext12pt,1.5linespacing.Margins:Top/Bottom2.54cm,Left/Right3.17cm.Criticalcontentandseals/uniqueidentifiersshallnotbemodified.AllinstructionsshallbeprovidedintheofficiallanguageofthetargetcountryandEnglish.Fordevicesintendedforhomeuse,thelocallanguageisstrictlymandatoryinallASEANmemberstates.ManufacturerDeclaration/制造商声明:ThisInstructionsforUse(IFU)istruthful,accurate,complete,andconsistentwiththeproducttechnicaldocumentation.Allrisk/adverseeventassessmentdatacontainedhereinarereliable.Theinstructionsarewritteninclearandunderstandablelanguage.TheUDIcodeisuniqueandtraceable.Forimportedproducts,abilingualversion(LocalLanguage/English)shallbeprovided.Themanufacturerundertakesthatallinformationistruthfulandvalid,anddoesnotfallbelowitsownstandards.ThisIFUhasbeenpreparedincompliancewithapplicableregulatoryrequirementsoftheASEANmemberstates,includingbutnotlimitedtoAMDDrequirements,individualcountryFDAregulations,andrelevantASEANsectoralharmonizationframeworks.Forpharmaceuticalproducts,thedossiershallcomplywiththeASEANCommonTechnicalRequirements(ACTR)andtheASEANCommonTechnicalDossier(ACTD).SpecialNotesforASEANMarkets/东南亚市场特别说明:Language/语言:AlllabelingandIFUmustbeprovidedintheofficiallocallanguageofthetargetmarket.Englishmaybeusedasasupplementarylanguageinmostmarkets(exceptforhome-usemedicaldeviceswhichstrictlyrequirelocallanguageinThailand,Indonesia,andMalaysia).UDI/唯一标识码:IndonesiarequiresUDIforClassC/Ddevicesfrom2026.SingaporeHSAhaspublishedUDIimplementationguidelines.ThailandandMalaysiaareprogressivelyimplementingUDIrequirements.LocalAuthorizedRepresentative/本地授权代表:AllASEANcountriesrequirealocalauthorizedrepresentative/agentformedicaldeviceandpharmaceuticalregistration,whoisresponsibleforregistrationsubmission,licensemanagement,andpost-marketsurveillance.HalalCompliance/清真合规:ForapplicableproductsinIndonesiaandMalaysia,Halalcertificationandlabelingmayberequired.IndonesiaisimplementingmandatoryHalalcertificationforcertainproductcategories.ASEANGuidelinesonProductSafetyLabelling(2026)/东盟产品安全标签指南:TheASEANCommitteeonConsumerProtection(ACCP)launchedtheASEANGuidelinesonProductSafetyLabellingon16April2026,requiringbasicwarninginformationaboutsafeproductuse,handling,anddisposalonlabels.封面页/CoverPageItem(English)Content(English)LocalLanguageItemLocalLanguageContentDocumentTitleInstructionsforUseJudulDokumen(ID)/ชื่อเอกสาร(TH)/TiêuđềTàiliệu(VN)PetunjukPenggunaan(ID)/คำแนะนำการใช้งาน(TH)/HướngdẫnSửdụng(VN)TradeName[InsertTradeName]NamaDagang(ID)[Insert/Masukkan]Generic/ProductName[InsertGenericProductName]NamaGenerik/Produk(ID)[Insert/Masukkan]Model/Type[InsertModelNumber]Model/Tipe(ID)[Insert/Masukkan]Specification[InsertSpecification]Spesifikasi(ID)[Insert/Masukkan]ManufacturerName[InsertFullLegalName]NamaProdusen(ID)[Insert/Masukkan]ManufacturerAddress[InsertFullAddress]AlamatProdusen(ID)[Insert/Masukkan]LocalAuthorizedRepresentative[InsertName,Addresspercountryrequirement]PerwakilanResmiLokal(ID)[Insert/Masukkan]Importer[InsertifdifferentfromLocalRep]Importir(ID)[Insert/Masukkan]Registration/AuthorizationNumber[Insertpercountry:IzinEdar(ID)/อย.(TH)/Sốđăngký(VN)/MDAReg.No.(MY)]NomorIzinEdar(ID)[Insert/Masukkan]UDI-DI[InsertUDI-DI]UDI-DI[Insert/Masukkan]RevisionNumberV3.0NomorRevisi(ID)V3.0DateofIssueYYYY-MM-DDTanggalTerbit(ID)YYYY-MM-DDLanguageEnglish&[LocalLanguageasrequiredbytargetcountry]Bahasa(ID)Inggris&[BahasaLokalsesuaiketentuannegaratujuan]Page1ofYHalaman(ID)1dariYNote:LocallanguagecolumnshowninBahasaIndonesiaasexample.ReplacewithThai,Vietnamese,Filipino,BahasaMalaysia,orotherofficiallanguageperthetargetASEANmarket.(ManufacturerSeal&Signature/Stempel&TandaTanganProdusen)目录/TableofContentsSectionTitle(English)LocalLanguageTitle(BahasaIndonesiaexample)Page1ProductIdentificationIdentifikasiProduk32IntendedUse/IndicationsforUseTujuanPenggunaan/IndikasiPenggunaan43ContraindicationsKontraindikasi54WarningsandPrecautionsPeringatandanKewaspadaan55AdverseEvents/SideEffectsKejadianTidakDiinginkan/EfekSamping66ProductDescriptionandCompositionDeskripsidanKomposisiProduk77InstructionsforUse/DosagePetunjukPenggunaan/Dosis88PerformanceCharacteristicsKarakteristikKinerja109Storage,Handling,andTransportPenyimpanan,Penanganan,danTransportasi1110ShelfLife/ExpirationDateMasaSimpan/TanggalKedaluwarsa1111UniqueDeviceIdentification(UDI)IdentifikasiPerangkatUnik(UDI)1212RiskManagementSummaryRingkasanManajemenRisiko1313LabelingandPackagingPelabelandanPengemasan1514RegulatoryComplianceandCertificationsKepatuhanRegulasidanSertifikasi1615SupplementaryInformationInformasiTambahan17AppendixABillofMaterials/TenderPricingTableLampiranA:DaftarHarga&TabelTender19AppendixBTechnicalSpecificationsComplianceTableLampiranB:TabelKesesuaianSpesifikasiTeknis21AppendixCElectronicIFUVersionControlLampiranC:KontrolVersie-IFU22Note:LocallanguagecolumnshowninBahasaIndonesiaasexample.ReplacewiththeofficiallanguageofthetargetASEANmarket.1.ProductIdentification/IdentifikasiProduk1.1ProductName(s)/NamaProduk[InsertTradeName/GenericNameasregisteredwiththerespectiveNationalRegulatoryAuthority(e.g.,Kemenkes/BPOMforIndonesia,ThaiFDAforThailand,MOH/DMAforVietnam,PhilippinesFDA,MDAforMalaysia,HSAforSingapore).Thenameshallclearlydescribeitsintendedpurpose.]1.2Model/TypeDesignation/PenunjukanModel/Tipe[Insert/Masukkannomormodel]1.3ProductCatalogueNumber/NomorKatalogProduk[InsertREF/MasukkanREF]1.4ProductClassification/KlasifikasiProdukClassificationAuthorityCategoryRiskClassIndonesia(Kemenkes/BPOM)□MedicalDevice(AlatKesehatan)□IVD□Pharmaceutical□ConsumerProduct□KelasA□KelasB□KelasC□KelasDThailand(ThaiFDA)□MedicalDevice□IVD□Pharmaceutical□ConsumerProduct□Class1□Class2□Class3□Class4(Licensed)□NotifiedVietnam(MOH/DMA)□MedicalDevice□IVD□Pharmaceutical□ConsumerProduct□LoạiA□LoạiB□LoạiC□LoạiDPhilippines(FDA)□MedicalDevice□IVD□Pharmaceutical□ConsumerProduct□ClassA□ClassB□ClassC□ClassDMalaysia(MDA)□MedicalDevice□IVD□Pharmaceutical□ConsumerProduct□ClassA□ClassB□ClassC□ClassDSingapore(HSA)□MedicalDevice□IVD□Pharmaceutical□ConsumerProduct□ClassA□ClassB□ClassC□ClassDGMDNCode[Insert/Masukkan]—1.5LocalContent/TKDN(forIndonesia)[ForgovernmentprocurementinIndonesia,certainproductsrequireaminimumTKDN(TingkatKomponenDalamNegeri)percentage.Specifyifapplicable./UntukpengadaanpemerintahdiIndonesia,produktertentumemerlukanpersentaseTKDNminimum.]2.IntendedUse/IndicationsforUse/TujuanPenggunaan/IndikasiPenggunaan2.1IntendedUse(MedicalDevice)/TujuanPenggunaan(AlatKesehatan)[Describetheintendedpurposeofthedevice,includingthetargetpopulation,anatomicalsite,andclinicalapplication.ThisstatementmustbeconsistentwiththeindicationsforuseclearedbytherespectiveNationalRegulatoryAuthority.ForIndonesia,thismustmatchtheIzinEdarapproval./Jelaskantujuanpenggunaanperangkat,termasukpopulasitarget,lokasianatomis,danaplikasiklinis.]IntendedUser/PenggunayangDituju:□HealthcareProfessional(inclinicalsettings)/TenagaKesehatanProfesional(difasilitasklinis)□LayPerson/Patient(forhome/over-the-counteruse)/OrangAwam/Pasien(untukpenggunaandirumah/tanparesep)2.2IndicationsforUse(Pharmaceutical)/IndikasiPenggunaan(Farmasi)[Listapprovedindicationsusingstandardinternationaldiseaseterminology(ICD-11)aswellaslocalmedicalterminologycommonlyusedinthetargetASEANcountry./Daftarindikasiyangdisetujuimenggunakanterminologipenyakitinternasionalstandar(ICD-11)sertaterminologimedislokal.]2.3IntendedEnvironmentofUse/LingkunganPenggunaanyangDituju[Hospital,clinic,homecare,etc.Noteanyenvironmentalconditions(temperature,humidity)relevanttotropicalASEANclimates./Rumahsakit,klinik,perawatanrumah,dll.CatatkondisilingkunganyangrelevandenganiklimtropisASEAN.]3.Contraindications/KontraindikasiNo.Contraindication(English)Explanation(English)Kontraindikasi(LocalLanguage)Penjelasan(LocalLanguage)1[Insert][Explain][Masukkan][Jelaskan]2[Insert][Explain][Masukkan][Jelaskan]WARNING/PERINGATAN:Donotusethisproductinpatientswiththeaboveconditionsunlessotherwisespecificallydirectedbyaqualifiedphysician./Jangangunakanprodukinipadapasiendengankondisidiataskecualidiarahkansecarakhususolehdokteryangberkualifikasi.4.WarningsandPrecautions/PeringatandanKewaspadaanNo.Category(English)Content(English)Kategori(LocalLanguage)Isi(LocalLanguage)1GeneralWarnings[Insert]PeringatanUmum[Masukkan]2MRISafety□MRSafe□MRConditional□MRUnsafe[Specify]KeamananMRI□AmanMRI□KondisionalMRI□TidakAmanMRI[Tentukan]3SpecificPopulations[e.g.,pregnancy,pediatric,geriatric,patientswithrenal/hepaticimpairment]PopulasiKhusus[mis.,kehamilan,anak,lansia,pasiengangguanginjal/hati]4Sterility□Sterile(Method:[])□Non-sterile.Donotuseifpackageisdamaged.Sterilitas□Steril(Metode:[])□Tidaksteril.Jangangunakanjikakemasanrusak.5SingleUse□Singleuseonly.Donotreuse,reprocess,orre-sterilize.SekaliPakai□Hanyauntuksekalipakai.Jangandigunakankembali,diprosesulang,ataudisterilkanulang.6Latex/PhthalatesContent□Containsnaturalrubberlatex.□Doesnotcontainlatex.□ContainsDEHP.KandunganLateks/Ftalat□Mengandunglatekskaretalam.□Tidakmengandunglateks.□MengandungDEHP.7HalalComplianceNote[Forapplicableproducts,indicateHalalcertificationstatusandwhethertheproductcontainsanyanimal-derivedoralcohol-basedcomponents.]CatatanKepatuhanHalal[Untukprodukyangberlaku,tunjukkanstatussertifikasiHalaldanapakahprodukmengandungkomponenturunanhewanatauberbasisalkohol.]8TropicalClimateConsiderations[NoteanyspecialstorageorhandlingrequirementsduetotropicalclimateconditionsinASEANcountries,e.g.,protectionfromhighhumidity,moldprevention.]PertimbanganIklimTropis[Catatpersyaratanpenyimpananataupenanganankhususkarenakondisiiklimtropisdinegara-negaraASEAN,mis.,perlindungandarikelembabantinggi,pencegahanjamur.]5.AdverseEvents/SideEffects/KejadianTidakDiinginkan/EfekSampingNo.AdverseEvent(English)Frequency(English)SeverityAction(English)KejadianTidakDiinginkan(LocalLanguage)Frekuensi(LocalLanguage)Tindakan(LocalLanguage)1[Insert]Common/Uncommon/RareMild/Moderate/Severe[Insert][Masukkan]Umum/Jarang/Langka[Masukkan]2[Insert]Common/Uncommon/RareMild/Moderate/Severe[Insert][Masukkan]Umum/Jarang/Langka[Masukkan]Reporting/Pelaporan:Anyseriousincidentthathasoccurredinrelationtothedeviceormedicineshouldbereportedtothemanufacturer,theLocalAuthorizedRepresentative,andtherespectiveNationalRegulatoryAuthority(e.g.,BPOM/KemenkesinIndonesia,ThaiFDAinThailand,DAVinVietnam,PhilippinesFDA,MDAinMalaysia,orHSAinSingapore)./Setiapinsidenseriusyangterjaditerkaitdenganperangkatatauobatharusdilaporkankepadaprodusen,PerwakilanResmiLokal,danOtoritasRegulasiNasionalmasing-masing.6.ProductDescriptionandComposition/DeskripsidanKomposisiProduk6.1Device/ProductDescription/DeskripsiPerangkat/Produk[Provideadetaileddescriptionofthedevice,itscomponents,theirinterconnection,andoperatingprinciple./Berikandeskripsirincitentangperangkat,komponennya,interkoneksinya,danprinsipoperasinya.]6.2ListofComponents/Materials/DaftarKomponen/MaterialNo.ComponentMaterialSpecificationSupplierCountryofOrigin1[Insert][Insert][Insert][Insert][Insert]2[Insert][Insert][Insert][Insert][Insert]6.3Accessories/Aksesori[Listallaccessoriessuppliedwiththedevice,includingtheirpartnumbersandintendedpurpose./Daftarsemuaaksesoriyangdisertakandenganperangkat,termasuknomorbagiandantujuanpenggunaannya.]6.4MaterialsinContactwithHumanBody/MaterialyangKontakdenganTubuhManusia[SpecifymaterialsandbiocompatibilitytestresultsinaccordancewithISO10993series./TentukanmaterialdanhasilujibiokompatibilitassesuaidenganseriISO10993.]6.5ActivePharmaceuticalIngredient(API)andExcipients/BahanAktifFarmasi(API)danEksipien[Forpharmaceuticals,listtheAPI(s)usingInternationalNonproprietaryNames(INN)andallexcipients.Clearlyidentifyanyexcipientsofanimalorigin,includingtheirHalalcompliancestatusforIndonesiaandMalaysiamarkets./Untukfarmasi,daftarAPImenggunakanNamaNonproprietaryInternasional(INN)dansemuaeksipien.Identifikasidenganjelaseksipienasalhewan,termasukstatuskepatuhanHalaluntukpasarIndonesiadanMalaysia.]6.6ProductWorkingPrinciple/MechanismofAction/PrinsipKerjaProduk/MekanismeKerja[Brieflyexplaintheworkingprincipleoftheproduct,includingthemechanismofactionforpharmaceuticals./Jelaskansecarasingkatprinsipkerjaproduk,termasukmekanismekerjauntukfarmasi.]7.InstructionsforUse/Dosage/PetunjukPenggunaan/DosisThischapteriswritteninclearandsimplebilinguallanguage(EnglishandthetargetASEANcountry'sofficiallanguage)toensureproperusebyallintendedusers./Babiniditulisdalambahasadwibahasayangjelasdansederhana(BahasaInggrisdanbahasaresminegaraASEANtarget)untukmemastikanpenggunaanyangbenarolehsemuapenggunayangdituju.7.1PreparationBeforeUse/PersiapanSebelumPenggunaanStep1/Langkah1:[Insert/Masukkan]Step2/Langkah2:[Insert/Masukkan]Step3/Langkah3:[Insert/Masukkan]7.2Operating/AdministrationProcedure/ProsedurPengoperasian/PemberianMethodA(Standard/MetodeStandar):[Provideastep-by-stepdescriptionsupportedbyillustrationswherenecessary./Berikandeskripsilangkahdemilangkahyangdidukungolehilustrasijikadiperlukan.]MethodB(Alternative/MetodeAlternatif):[Insertifapplicable./Masukkanjikaberlaku.]7.3Dosage(forpharmaceuticals)/Dosis(untukfarmasi)PopulationDosageFrequencyMax.DailyDoseNotesAdults/Dewasa[Insert][Insert][Insert][Insert]Pediatric(AgeGroup)/Anak(KelompokUsia)[Insert][Insert][Insert][Insert]Geriatric(≥65)/Lansia(≥65)[Insert][Insert][Insert][Insert]PatientswithRenal/HepaticImpairment/PasiendenganGangguanGinjal/Hati[Insert][Insert][Insert][Insert]7.4SpecialUserInstructions/PetunjukPenggunaKhusus[Fordevicesintendedforlayuse,provideclear,understandableinstructionsinplainlanguage.InThailand,home-usedevicesmusthavelabelsandIFUsstrictlyinThai.InMalaysia,devicesintendedforhomeusemustalsoincludeBahasaMalaysia.InVietnam,labelingandIFUmustbeinVietnameseforhome-usedevices./Untukperangkatyangditujukanuntukpenggunaanolehorangawam,berikanpetunjukyangjelasdanmudahdipahamidalambahasasederhana.]7.5ReprocessingInstructions(forreusabledevices)/PetunjukPemrosesanUlang(untukperangkatyangdapatdigunakankembali)[Providedetailedcleaning,disinfection,packaging,andsterilizationmethods,aswellasthemaximumnumberofreuses./Berikanmetodepembersihan,desinfeksi,pengemasan,dansterilisasiyangrinci,sertajumlahmaksimumpenggunaankembali.]8.PerformanceCharacteristics/KarakteristikKinerja8.1TechnicalSpecifications/SpesifikasiTeknisNo.ParameterSpecificationTestMethodStandard1[Insert][Insert][Insert][e.g.,IEC60601,ISO80601]2[Insert][Insert][Insert][e.g.,ASTMF,ISO10993]8.2ClinicalPerformanceSummary/RingkasanKinerjaKlinis[ProvideabriefsummaryofclinicaldatasupportingsafetyandperformanceinaccordancewithrelevantASEANCSDTrequirementsandindividualcountryrequirements./BerikanringkasansingkatdataklinisyangmendukungkeamanandankinerjasesuaidenganpersyaratanCSDTASEANyangrelevandanpersyaratanmasing-masingnegara.]8.3ElectricalSafetyandEMC/KeamananListrikdanEMC[Forelectronicproductsandactivemedicaldevices,specifycompliancewithrelevantIECstandardsandnationalvariants.NotethatSingaporerequiresMEPSandMELScomplianceforhouseholdappliances(airconditioners,refrigerators,dryers,TVs,lamps)fromJuly1,2026./Untukprodukelektronikdanperangkatmedisaktif,tentukankepatuhandenganstandarIECyangrelevandanvariannasional.]9.Storage,Handling,andTransport/Penyimpanan,Penanganan,danTransportasiConditionRequirementLocalLanguageTemperature/Suhu[XX°CtoXX°C][XX°ChinggaXX°C]RelativeHumidity/KelembabanRelatif[XX%toXX%][XX%hinggaXX%]ProtectionfromLight/PerlindungandariCahaya□Yes/Ya□No/Tidak□Ya□TidakSpecialConditions/KondisiKhusus[e.g.,Donotfreeze.Storeinadryplace./Jangandibekukan.Simpanditempatkering.][mis.,Jangandibekukan.Simpanditempatkering.]TransportConditions/KondisiTransportasi[Specify,consideringtropicalclimateconditionsinASEANcountries(hightemperature,highhumidity,potentialformoldgrowth)./Tentukan,denganmempertimbangkankondisiiklimtropisdinegara-negaraASEAN(suhutinggi,kelembabantinggi,potensipertumbuhanjamur).][Tentukan]SupplyChainNotes/CatatanRantaiPasokan[e.g.,Coldchain(2-8°C)requirementswithtemperaturemonitoringdevices./mis.,Persyaratanrantaidingin(2-8°C)denganperangkatpemantausuhu.][mis.,Rantaidingin]10.ShelfLife/ExpirationDate/MasaSimpan/TanggalKedaluwarsaItemContentShelfLife/MasaSimpan[Xyears/monthsfromdateofmanufacture/Xtahun/bulandaritanggalproduksi]DateofManufacture/TanggalProduksiYYYY-MM-DDUsebyDate/ExpirationDate/GunakanSebelum/TanggalKedaluwarsaYYYY-MM-DDLabelFormat/FormatLabelUsebyYYYY-MM-DD/GunakanSebelumYYYY-MM-DDIndonesiaDateFormat/FormatTanggalIndonesiaDD/MM/YYYYformatisrequiredforIndonesianlabelsThailandDateFormat/FormatTanggalThailandBuddhistEra(B.E.)yearmaybeusedalongsideGregorian(C.E.)yearTropicalClimateNote/CatatanIklimTropisForproductsdistributedinASEANcountries,stabilitydatamustsupportstorageinZoneIVbconditions(hotandveryhumid,30°C/75%RH)asdefinedbyICHstabilityguidelinesforASEAN11.UniqueDeviceIdentification(UDI)/IdentifikasiPerangkatUnik(UDI)ThisproductcomplieswiththeIMDRFUDIApplicationGuideandapplicableASEANmemberstateUDIregulations.UDIimplementationisprogressiveacrossASEANcountries:IndonesiarequiresUDIforClassCandDdevicesfrom2026;SingaporeHSAhaspublishedUDIimplementationguidelines;Thailand,Malaysia,andthePhilippinesareprogressivelyimplementingUDIrequirements.ItemContentIssuingAgency/LembagaPenerbit□GS1□HIBCC□ICCBBAUDI-DI(DeviceIdentifier)/PengenalPerangkat[InsertUDI-DI/MasukkanUDI-DI]UDI-PI(ProductionIdentifier)/PengenalProduksiIncludes/Termasuk:□Lot/BatchNo./No.Lot/Batch□SerialNo./No.Seri□ManufacturingDate/TanggalProduksi□ExpirationDate/TanggalKedaluwarsaCompleteUDIString/StringUDILengkap[(01)XXXXXXXXXXXXXX(17)XXXXXX(10)XXXXXX(21)XXXXXX]DataCarrierType/TipePembawaData□GS1-128□GS1DataMatrix□RFID□DirectMarking/PenandaanLangsungPlacement/Penempatan□DeviceLabel/LabelPerangkat□Packaging/Kemasan□DeviceItself/PerangkatItselfNote/Catatan:TheUDIcodeistheuniqueidentityofthisproductandshallnotbecounterfeited,altered,orreused.ForIndonesia,UDIdatashallberegisteredintheBPOMUDIdatabase./KodeUDIadalahidentitasunikprodukinidantidakbolehdipalsukan,diubah,ataudigunakankembali.UntukIndonesia,dataUDIharusdidaftarkandidatabaseUDIBPOM.12.RiskManagementSummary/RingkasanManajemenRisiko12.1RiskManagementBasis/DasarManajemenRisikoRiskmanagementisperformedinaccordancewithISO14971:2019(Medicaldevices—Applicationofriskmanagementtomedicaldevices).UnderAMDD,manufacturersarerequiredtoprovideacleardescriptionidentifyingallapplicableEssentialPrinciplesofSafetyandPerformance(EPSP)perAnnex1andtooutlinethegeneralmethodsusedtodemonstrateconformitywitheachprinciple.Riskanalysismustbeconductedbasedoninternationallyrecognizedstandards,listingallpotentialhazards,specifyingtheriskassessmententityandanalysismethodology,andexplainingriskcontrolmeasuresandacceptabilityconclusions.12.2RiskAcceptabilityCriteria/KriteriaPenerimaanRisikoCriterionDefinitionProbability(P)1(Improbable/TidakMungkin)to5(Frequent/Sering)Severity(S)1(Negligible/DapatDiabaikan)to5(Catastrophic/Bencana)12.3RiskEvaluationMatrix(5x5)/MatriksEvaluasiRisiko(5x5)Probability/SeverityS1(Negligible)S2(Marginal)S3(Moderate)S4(Critical)S5(Catastrophic)P5(Frequent)AcceptableALARPUnacceptableUnacceptableUnacceptableP4(Probable)AcceptableALARPALARPUnacceptableUnacceptableP3(Occasional)AcceptableAcceptableALARPALARPUnacceptableP2(Remote)AcceptableAcceptableAcceptableALARPALARPP1(Improbable)AcceptableAcceptableAcceptableAcceptableAcceptable12.4RiskIdentificationandAnalysisTable/TabelIdentifikasidanAnalisisRisikoNo.HazardCategoryHazardDescriptionHazardousSituationInitialP/S/RPNControlMeasuresResidualP/S/RPNAcceptability1Energy/Biological/Chemical/Use/Information[Describe][Describe]P:4S:4RPN:16[Insertcontrols]P:2S:2RPN:4Acceptable2Energy/Biological/Chemical/Use/Information[Describe][Describe]P:3S:3RPN:9[Insertcontrols]P:1S:2RPN:2Acceptable12.5Benefit-RiskAnalysisConclusion/KesimpulanAnalisisManfaat-RisikoTheoverallresidualriskisacceptablewhenweighedagainsttheanticipatedclinicalbenefits.Post-marketsurveillancewillcontinuouslymonitorrisksinaccordancewithAMDDrequirementsandindividualASEANmemberstateregulations./Risikoresidualsecarakeseluruhandapatditerimajikadibandingkandenganmanfaatklinisyangdiantisipasi.Pengawasanpasca-pasarakanterusmemantaurisikosesuaidenganpersyaratanAMDDdanperaturanmasing-masingnegaraanggotaASEAN.13.LabelingandPackaging/PelabelandanPengemasan13.1GeneralLabelingRequirementsforASEAN/PersyaratanPelabelanUmumuntukASEANASEANCSDTRequirements/PersyaratanCSDTASEAN:Labelsshallincludeproductpackaginglabels,instructionsforuse,andpatientoperationguides.Forlargeequipment,labelphotographsordrawingsmaybesubmittedinlieuofphysicallabels.Language/Bahasa:AlllabelingshallbeprovidedintheofficiallanguageofthetargetASEANmarket.Englishmaybeusedasasupplementarylanguageinmostmarkets,exceptforhome-usemedicaldeviceswhichstrictlyrequirelocallanguageinThailand,Indonesia,andMalaysia.ASEANProductSafetyLabelingGuidelines(2026)/PedomanPelabelanKeamananProdukASEAN(2026):TheACCPlaunchedtheASEANGuidelinesonProductSafetyLabellingon16April2026,requiringbasicwarninginformationaboutsafeproductuse,handling,anddisposalonlabels.Country-SpecificSymbolsandCertifications:EachASEANcountrymayrequirespecificnationalsymbols(e.g.,MDregistrationnumber,IzinEdarnumber,อย.number,MDAregistrationnumber).13.2KeyInformationonLabel/InformasiUtamapadaLabelProductname(TradeandGeneric)/Namaproduk(DagangdanGenerik)Modelorreferencenumber/NomormodelataureferensiManufacturernameandaddress/NamadanalamatprodusenLocalAuthorizedRepresentativenameandaddress(country-specific)/NamadanalamatPerwakilanResmiLokalLot/Batchnumberorserialnumber/Nomorlot/batchataunomorseriDateofmanufacture(DD/MM/YYYYformatforIndonesia)andexpirydateUDIcarrier(AIDCandHRI)/PembawaUDIStorageandhandlingconditions(considerZoneIVbtropicalconditions)/KondisipenyimpanandanpenangananSterilityindicationandsterilizationmethod,ifapplicable/Indikasisterilitasdanmetodesterilisasi"RxOnly"or"OTC"designationforpharmaceuticals/Penunjukan"RxOnly"atau"OTC"Halalcertificationmark(forapplicableproductsinIndonesiaandMalaysia)/TandasertifikasiHalalCountry-specificregistration/notificationnumber(e.g.,NomorIzinEdar,อย.number,MDAReg.No.)CountryofOrigin/NegaraAsal13.3Country-SpecificLabelingHighlights/SorotanPelabelanSpesifikNegaraCountryKeyRequirementsIndonesiaAlllabelsmustbeinBahasaIndonesia,optionallywithEnglish.DD/MM/YYYYdateformat.Mustinclude:productname(exactlyasregistered),model/specification,manufacturer/importeraddress,lot/serialnumber,manufacturingdate,expirationdate,instructionsforuse,indications,contraindications,storageconditions,andsafetywarnings.BPOMregistrationandTKDNcompliancemayapply.UDIrequiredforClassC/Ddevicesfrom2026.ThailandHome-usedevices:LabelsandIFUmustbeinThai(2026B.E.2568labelingregulation,effectiveJune20,2026).Professional-usedevices:LabelsandIFUmaybeinThaiorEnglish.Importersmustcompletecompliantin-countrylabelingwithin120daysoflicenseissuance.ThaiFDA(อย.)registrationnumberrequired.VietnamDecree37/