关于我们 ABOUTUS
TTMedicalManagementSdnBhdisanestablishedAuthorisedRepresentative (“AR”)company.WearelicensedbytheMedicalDeviceAuthority(“MDA”)which regulatesmedicaldevicesunderthe“MedicalDeviceAct2012”and“Medical DeviceRegulations2012”.Undertheregulation,allforeignmanufacturersmust appointanARtosubmittheregistrationapplicationoftheirmedicaldevices.
Vision
我们的愿景
We are a strong and dynamic regulatory compliance consultantfor medical devices and pharmaceuticals. We deliver excellent services which have great in uence on industries and impactonnation.
Weprideourselvesasbeingthetrendsetterthatcanimpactnationby settingtheinternationalstandardinprovidingexcellence.
TTMedicalisoneofMalaysia’searlymedicaldeviceregulatoryconsultancies, withover20yearsofindustryexperiencespecializinginMalaysiaandIndonesia marketaccess.
TTTraining&ConsultingEstablished
TTMedicalManagementEstablished
PTTTMedika,IndonesiaEstablished FirstapprovalundertheMalaysia–China RegulatoryRelianceProgramme.
核心业务
OURREGULATORYSERVICES
MedicalDeviceRegistration(Malaysia&Indonesia)
提供马来西亚（MDA）及印尼医疗器械注册路径评估、技术文件准备及申报支持。
End-to-endregulatorysupportformedicaldeviceregistrationinMalaysia(MDA) andIndonesia.
IVD体外诊断产品注册（IVDRegistration）
提供体外诊断产品注册路径评估与申报支持。
RegulatorypathwayassessmentandsubmissionsupportforIVDdevices.
本地授权代表服务（LocalAuthorizedRepresentative(LAR)）
协助完成马来西亚医疗器械分类评估、技术文件准备及注册申报。
End-to-end support for device classification, technical documentation preparation,andsubmissiontoMDA.
医疗器械注册（MedicalDeviceRegistration(ClassA–D)）
协助完成马来西亚医疗器械分类评估、技术文件准备及注册申报。
End-to-end support for device classification, technical documentation preparation,andsubmissiontoMDA.
RegulatoryCoverage
服务产品范围
MedicalDevices医疗器械
Generalmedicaldevicesincludingdiagnostic,therapeutic, andmonitoringequipment.诊断、治疗及临床类医疗器械产品。
PharmaceuticalProducts药品
Prescriptionandover-the-counterpharmaceutical products.处⽅药及⾮处⽅药等药品产品。
HealthSupplements
保健品
Vitamins,dietarysupplements,andnutraceuticalproducts.
维⽣素、膳⻝补充剂及营养保健产品。
Cosmetics化妆品
Skincare,beauty,andpersonalcarecosmeticproducts.
护肤、美容及个⼈护理类化妆品产品。
We are committed to delivering regulatory solutions with precision, compliance,ande ciency.Throughstructuredprocessmanagementand risk assessment, we ensure every submission meets regulatory requirementswhileminimizingapprovalrisks.
We support leading medical device manufacturers worldwide in achieving regulatorycomplianceandmarketaccessinMalaysiaandIndonesia.我们为全球医疗
PartneringforRegulatory SuccessinSoutheastAsia
携手实现东南亚医疗器械合规与市场准入
TTMedicalManagementsupportsglobalmedicaldevicemanufacturerswith practicalregulatorysolutionsforSoutheastAsia.TTMedicalManagement为全
OurStrength
Extensive experience in medical device regulatorycompliance Regulatory Expertise
在医疗器械法规合规方面拥有丰富经验，熟悉马来西亚及印尼医疗器械 监管体系与注册流程。
Local Representation
Market Access
Industry Experience
ActingasLocalAuthorizedRepresentative forforeignmanufacturers
为境外医疗器械制造商提供本地授权代表（LAR）服务，协助与监管机 构沟通并完成合规申报。
Supporting e cient market entry in MalaysiaandIndonesia
协助企业制定合规的市场准入策略，顺利进入马来西亚及印尼医疗器械 市场。
Strongunderstandingofregionalregulatory requirements
具备多年医疗器械法规服务经验，对东南亚医疗器械法规环境及行业需 求有深入理解。
