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Medical Devices Registration in Bangladesh

We help you to prepare Medical Device Technical File (MDR) as per the regulatory requirement of EU MDR 745/2017 and submit to notified body for review and approval of CE certification. In Bangladesh, the Directorate General of Drug Administration (DGDA) oversees medical devices registration. Operating under the Ministry of Health and Family Welfare, DGDA regulates the import, production, distribution, and sale of medical devices, emphasizing quality and safety standards. <br>

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Medical Devices Registration in Bangladesh

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  1. MEDICALDEVICES REGISTRATIONINBANGLADESH www.mavenprofserv.com

  2. Overview BangladeshMedicalDeviceRegulations MedicalDeviceStatus MedicalDeviceClassificationSystem MedicalDeviceRegistrationProcess

  3. BangladeshMedicalDeviceRegulations In Bangladesh,theDirectorate General of Drug Administration (DGDA) overseesmedicaldevicesregistration.Operating under the Ministry of Health and Family Welfare, DGDA regulates the import,production,distribution,andsaleofmedicaldevices, emphasizingqualityandsafetystandards.DGDA’sroleispivotal in ensuring the efficacy and reliability of medical devices through stringentoversightandcountryregistrations.

  4. InBangladesh,theBangladeshDrugandCosmeticsAct of2023, enactedonSeptember18,servesasthecornerstoneofregulatory provisionsgoverningmedicaldevicesandpharmaceuticals.This legislation addresses crucial aspects such asmanufacturing, importing, distributing,andsellingmedicaldevices,primarilyfocusingon ensuringadherencetoqualityandsafetystandards. OnesignificantrequirementoutlinedintheBangladeshDrugand CosmeticsActisthenecessityformedicaldeviceregistration. Manufacturersand importersmustobtain country registrationsfrom theappropriateregulatoryauthorities.

  5. MedicalDeviceStatus As of September 18,2023,the Government of Bangladesh introduced the Drug and Cosmetics Act, 2023,outlining regulations for medical devices,IVD reagents,andsoftware.This act expandsthe definition ofmedicaldevices,nowencompassingsoftwareunderdrug regulations According to the Drugs and Cosmetics Act, 2023,amedical device is definedasfollows:“Medicaldevice”encompasses:

  6. (a)Variousdevicessuchasinstruments,apparatus,implements, machines,appliances,implants,diagnosticreagents(invitro,in vivo, andsilicoreagents),software,orrelatedmaterials.Theseareused eitherindependentlyorincombinationforspecificpurposes, including: Diagnosis,prevention,monitoring,treatment,oralleviationof diseasesordisorders; Diagnosis,monitoring,treatment,alleviation,orassistancefor injuriesordisabilities;

  7. modification, or support of (iii) Investigation, replacement, anatomyorphysiologicalprocesses; Supportingorsustaininglife; Conceptioncontrolormedicaldevicedisinfection; Providinginformationthroughexaminingandanalyzing samplescollectedfromhumanoranimalbodies,unaffectedby pharmacological,immunological,ormetabolicactions.

  8. (b)Additionally, anydevice ordiagnosticreagentdeclaredbythe government,throughnotificationintheOfficial Gazette,forthis Act. Thiscomprehensivedefinitionbroadensthescopeofmedical devicesundertheregulatorypurview,ensuringthesafetyand efficacy of productsintended for usein Bangladesh.It underscores theimportanceofadherencetoregulationsformanufacturers seekingmedicaldevicesregistrationinBangladesh.

  9. MedicalDeviceClassificationSystem

  10. MedicalDeviceRegistrationProcess SubmissionofApplications DocumentPreparation ComplianceAssessment Inspection ReviewandApproval RegistrationCertificateIssuance Renewal Post-MarketSurveillance

  11. AtMaven,ourcommitmentgoesbeyondofferingexceptional services;weprioritizekeepingourclientsinformedabout Bangladesh’sevolvingregulatorylandscape,especiallyconcerning medicaldevicesregistration.Ourproactiveapproachensures clients stayupdated on anypertinent updates, bethey changesin compliancestandardsorapproachingregistrationdeadlines. We recognizethat compliance isjust oneaspect;ourultimate goal istoempowerbusinessestoreachtheirfullpotentialglobally.

  12. Contact Us https://mavenprofserv.com/medical-devices-registration- in-bangladesh/ business@mavenprofserv.com enquiry@mavenprofserv.com

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