Medical Device Regulations In India

Medical Device RegulationsIn IndiaDr. Ravi Kant SharmaAssistant Drugs Controller(I)Central Drugs Standard Control OrganisationNew Delhi

Drugs and Cosmetics Act and Rules:Objective of Drugs & Cosmetic Act 1940 & Rules 1945:To ensure safety, efficacy and quality of productsRisksBenefits

Drug and Cosmetics Act and Rules:Preamble:To regulate Manufacture, Sale, Distribution and Import al Devices3

Drug is in concurrent list of Indian ConstitutionIt is governed by both Centre and StateGovernments under the Drugs & CosmeticsAct, 1940

Functions of CDSCOFunctions of CDSCOApproval of new drugs and clinical trialsImport Registration and LicensingLicensing of Blood Banks, LVPs, Vaccines, r-DNAproducts & some Medical DevicesAmendment to D &C Act and RulesBanning of drugs and cosmeticsGrant of Test License, Personal License, NOCs for ExportTesting of Drugs

Functions of State Licensing AuthoritiesFunctions of State Licensing AuthoritiesLicensing of Manufacturing Site for Drugs including API andFinished FormulationLicensing of Establishment for sale or distribution of DrugsApproval of Drug Testing LaboratoriesMonitoring of Quality of Drugs and Cosmetics marketed in thecountryInvestigation and prosecution in respect of contravention oflegal provisionRecall of sub-standard drugs

Central Drugs Standard Control OrganizationDrugs Controller General (I)HEAD QUARTERZONALOFFICE (6) New Drugs GMP Audits Clinical Trials Imports Biological MedicalDevices Export QC Pharmco.Vig Legal etc Enforcement Draw drugSamplesSUB ZONALOFFICE (4) GMP Audits Coordinationwith StatesPORT OFFICE(13) Import ExportLABORATORY(7) TestingofDrugs Validation ofTest protocols

Drug Testing LaboratoriesNational Laboratories: 7State Labs: 31For Vaccines: CRI, KasauliFor r-DNA and Diagnostic kits – NIB, NoidaFor Medical Devices(Mechanical Contraceptives)Central Drug Testing Laboratory(CDTL), ChennaiImport and Export of Drugs from notified ports only

Medical Devices : Current RegulationsØ Medical Devices are notified as DRUGS under Drugs &Cosmetics Act.Section 3 (b) (iv) defines, Medical Devices as“Devices intended for internal or external use in the diagnosis, treatment,mitigation or prevention of disease or disorder in human beings oranimals”Ø GMP Requirements are specified under Schedule M IIIØ Rule 109-ALabeling of Medical DevicesØ Rule 125-AStandards for Medical Devices“Currently, 14 medical devices have been notified asDrugs”

14 Notified Medical DevicesS.NoName of the deviceNotificationNumberDate ofnotification1Disposable Hypodermic SyringesGSR 365 (E)17-03-19892Disposable Hypodermic NeedlesGSR 365 (E)17-03-19893Disposable Perfusion SetsGSR 365 (E)17-03-19894In vitro Diagnostic Devices for HIV, HbsAg andHCVGSR 601(E)27-08-20025Cardiac StentsS.O. 1468 (E)06-10-20056Drug Eluting StentsS.O. 1468 (E)06-10-20057CathetersS.O. 1468 (E)06-10-20058Intra Ocular LensesS.O. 1468 (E)06-10-20059I.V. CannulaeS.O. 1468 (E)06-10-200510Bone CementsS.O. 1468 (E)06-10-200511Heart ValvesS.O. 1468 (E)06-10-200512Scalp Vein SetS.O. 1468 (E)06-10-200513Orthopedic ImplantsS.O. 1468 (E)06-10-200514Internal Prosthetic ReplacementsS.O. 1468 (E)06-10-2005

Sr.No.Name of thedevice1PictureMaterial ofconstructionIntended useDisposableHypodermicSyringesPlasticSyringes are oftenused to administerinjections,insertintravenous drugs intothe bloodstream.2DisposableHypodermicNeedlesStainless steelused with a syringeto inject substancesinto the body orextract fluids from it.3DisposablePerfusion setPlasticFor transfusion of I.V.Fluid into thebloodstream.4Cardiac Stentsstainless steeland cobaltchromium,titaniumIt helps to preventarteries from renarrowing after anangioplasty.

Sr.NoName of thedevice5PictureMaterial ofconstructionIntended useDrug ElutingStentsStainlesssteel,titanium and cobaltchromium (Drugs –Paclitaxel,Everolimus,Rapamycin)It keep the arteriesopen in the treatmentof Coronary heartdisease.6CatheterSilicon rubber, latexIt allow drainage,administration offluids or gases, oraccess by surgicalinstruments7Intra OcularLenses(PMMA) Polymethylm It is used for theethacrylatetreatment ofcataracts.8I.V. CannulaePlasticIt can be inserted intothe body, often for thedelivery or removal offluid9Bone Cements(PMMA) PolymethylmethacrylateIt fills the free spacebetween theprosthesis andthe bone.

Sr.No.Name of thedevicePictureMaterial ofconstructionIntended use10Heart ValvesSyntheticIt allows blood flow inmaterial, Animal only one directionorigin (Bovine,through the heartProcine)11Scalp Vein SetPlasticItsproviderapidvenous access duringinfusion.12OrthopaedicImplantsStainless steel,Nitinol,Titanium, cobaltchromiumIts used to replace orprovide fixation ofbone or to replacearticulating surfacesof a joint13Internal portion of the eyesurrounded by thesocket and coveredexternallybytheeyelids. The eye itself.14In vitro DiagnosticDevices for HIV,HBsAg and HCVNitrocellulosemembraneFor quantitativedetection of HIV,HBsAg and HCV in

Devices are not drugs!10/1/2013Devices are not DrugsOne size does not fit all

DrugDeviceBased on Chemistry & PharmacologyBased on EngineeringSafety and EfficacySafety and Performance/AccuracyClinical Trials(4 Phases)Clinical Evaluation(Feasibility/Pivotal)GMPQMSLocal and Systemic ToxicityBiocompatibilityLong Product Life CycleShort Product life CycleDrug InteractionsDevice Malfunction

DrugDeviceClearly specified, For Eg. ParacetomolBased on design, effectiveness andIntended useDesign changes quiet frequently likeMobile models.Regulated by licensing systemRegulated by notified bodies(in most ofthe countries)Clearly specified labeling requirementsAs per ISOSymbol are usedBulk or FormulationComponents or Accessories orAssembled or Finished productAround 65 years experienceOnly Seven years experience

10/1/2013DrugsDrug interactionsWrong drug/wrong doseDevicesMalfunctionUser error

10/1/2013DrugsClinical trialClinical endpointsDevicesRisk-basedSurrogate endpoints

Organogram of Medical Device Division:

Functions of CDSCOFunctions of Medical Device DivisonImport Registration and Licensing of Medical DevicesApproval of New Medical DevicesManufacturing License to Indigenous Manufacturer underCLAA SchemeGrant of Test LicenseNOC’s for Import/ClarificationsNeutral Code For ExportClinical Trials

Import, Registration and LicensingImport. Registration & LicensingMfg sites and Products are required to be RegisteredIssue of Registration Certificate in Form 41Issue of Import License in Form 10 / 10ARules21 to 30ScheduleDI & DIIRules related to grant of Registration Certificateand Import LicenseInformation required for registration ofMfg site and ProductTimeline as per D & C RulesFor RC: Rules, 9 MonthsFor Import License: 3 MonthsRegistration Certificate(RC) andImport License - Valid for 3 years

Registration & Import ProcedureImport ProcedureApplication For Registration(Form- 40/ Schedule D(I)/ Schedule D(II), Power of Attorney)Application Fees:Mfg. Site Registration1500 USD per SiteProduct RegistrationRegistration Certificate issued by CDSCO(Form-41)1000 USD perproductApplication Fees:Application For Import License(Form-8, Form 9)Drug LicenseSell, Stock & Exhibitby SLAImport License issued by CDSCO(Form- 10)INR1000(22 USD )

New Medical DeviceApproval of New Medical DevicesAppl. in Form44 as per Schedule YTR6 Challan of Rs.50000/Review of Clinical Trial Protocol, Published reports,literature, Package Insert etc by CDSCOEvaluation By Medical Device AdvisoryCommitteeOn Basis of Recommendations of MDACPermission Under Rule-122A grantedRegistration andForm-10

Medical Device Advisory CommitteeSix Medical Device Advisory Committees ConstitutedØ MDAC - CardiovascularØ MDAC -DentalØ MDAC - Reproductive and UrologyØ MDAC - OrthopedicsØ MDAC - OphthalmicØ MDAC - Miscellaneous

Approval of Clinical Trials & Import of New Medical DevicesClinical Trial RegulationRequirements and Guidelines - Schedule YRule 122 APermission to import new drugRule 122 BPermission to manufacture new drugRule 122 DADefinition of Clinical trialsRule 122 EDefinition of New Drugs*

Regulation of Clinical Trials:Ø Clinical Trials are regulated under theprovisions of Drugs and Cosmetics RulesØ No clinical trials of New Drugs can beconducted without permission

Initiatives taken- IND Committee for evaluation of Investigational New Drugs- 12 New Drug Advisory Committees (NDACs) for Evaluationof clinical trials and new drug approvals- 6 Medical Devices Advisory Committees- Mandatory registration of Clinical Trials (Clinical Trial Registryof India)

Concerns in Clinical TrialsØ Review of Clinical Trial applicationsØ Obtaining Informed Consent of subjectsØ Examination of reports of Serious AdverseEvents (SAEs)Ø Compensation for clinical trial related injury ordeathØ Monitoring of Clinical TrialsØ Functioning of Ethics Committees

CLAA ApprovalCLAA Approval for Indigenous ManufacturerØ The “Guidance Document on Application for Grant ofLicence in Form-28 for Manufacture of Medical Devicesin India under CLAA Scheme” indicates the applicationrequirements for a medical device manufacturinglicense.Ø The manufacturing site is jointly inspected by theCDSCO Officials and State Drugs Control Officers.

CLAA ProcedureApplication in Form-27 along with fees, DMF & PMFDCGIReview & ExaminationDirects Zonal office forJoint InspectionState LicensingAuthorityZonal OfficeJoint Inspection ReportThe State Licensing Authority after Joint Inspection and verificationforward the license in triplicate to CLAA for approval.The license shall be issued in Form 28 after due approval of CLAA.

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New Medical Device Review of Clinical Trial Protocol, Published reports, literature, Package Insert etc by CDSCO Appl. in Form44 as per Schedule Y TR6 Challan of Rs.50000/ Evaluation By Medical Device Advisory Committee On Basis of Recommendations of MDAC Permission Under Rule-122A granted Registration and