The addition of the medical device law by the Drug Regulatory of Pakistan to register medical devices in Pakistan, as per national requirements (equivalence of FDA, CE, and ISO)

1. In the name of ALLAHIn the name of ALLAH
MEDICAL DEVICES RULES
2015

3. DRAP
Drug Regulation
Authority of Pakistan
MEDICAL DEVICES RULES
2015
MEDICA
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4. DRAP
Drug Regulation
Authority of Pakistan
MEDICAL DEVICE RULES
2015
MEDICA
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2015

5. CONSENSUS
MEDICA
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7. Drug Regulation Authority of Pakistan
MEDICAL DEVICE RULES
2015
MEDICA
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2015
DRA
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8. TO BE PUBLISHED IN PART – II OF THE EXTRAORDINARY GAZZETE OFTO BE PUBLISHED IN PART – II OF THE EXTRAORDINARY GAZZETE OF
PAKISTANPAKISTAN
GOVERNMENT OF PAKISTANGOVERNMENT OF PAKISTAN
DRUGS REGULATORY AUTHORITY OF PAKISTANDRUGS REGULATORY AUTHORITY OF PAKISTAN
MINISTERY OF NATIONAL HEALTH SERVICES,REGULATION ANDMINISTERY OF NATIONAL HEALTH SERVICES,REGULATION AND
COORDINATIONCOORDINATION
NOTIFICATIONNOTIFICATION
S.R.O 204(I)/2015S.R.O 204(I)/2015 Islamabad, theIslamabad, the 99thth
March,2015March,2015
In exercise of the power conferred byIn exercise of the power conferred by section 23section 23 of Drugof Drug
Regulatory Authority of Pakistan, with approval of the FederalRegulatory Authority of Pakistan, with approval of the Federal
Government , is pleased to make the following rules , being madeGovernment , is pleased to make the following rules , being made
on the first occasion namelyon the first occasion namely
““ MEDICAL DEVICES RULES , 2015MEDICAL DEVICES RULES , 2015 ””
Shall come into force at once.Shall come into force at once.
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9. Medical Devices Rules
2o15
SUMMARYSUMMARY
CAB
Conformity
Assessment
Body
Rules : 146
Chapters: 19
Formats : 21
Pages : 119
9.3.15
Controlling Authority
MDB
Medical Devices
Board
Exemptions :
YES
For
Registration of
Devices
For
Licenses, Registration
Import/Export of
Medical Devices
Registere
d
With MDB
DRA
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10. MEDICAL DEVICE RULE
2015
HISTORY
NEED
SCOPE
PURPOSE
MEDICA
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11. MEDICAL DEVICES RULES ,2015MEDICAL DEVICES RULES ,2015 ………………………………
HISTORYHISTORY
 11STST
time introduced by USA in 1976time introduced by USA in 1976
 PakistanPakistan the 1the 1stst
country in South Asia to implement these rulescountry in South Asia to implement these rules
 Yet not applied on devices in India & BangladeshYet not applied on devices in India & Bangladesh
 Drug act 1976 covered only syringes/stents/catheters forDrug act 1976 covered only syringes/stents/catheters for
registrationregistration
 In 1996 issue of hepatitis due to reuse of syringes raised Govt. triedIn 1996 issue of hepatitis due to reuse of syringes raised Govt. tried
toto regulate but manufacturers took stay which stood for 10 years.regulate but manufacturers took stay which stood for 10 years.
 Resistance by stake holders to regulate medical devicesResistance by stake holders to regulate medical devices
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12. NEEDNEED
 No check & balance on devices used for human healthNo check & balance on devices used for human health
 Contamination hazards of metals/reagents/chemicalsContamination hazards of metals/reagents/chemicals
 No proper calibrations as per ISO standardsNo proper calibrations as per ISO standards
 Violations of usage/claims due to non market surveillanceViolations of usage/claims due to non market surveillance
 Spread of hepatitis & other infectious diseases blood productsSpread of hepatitis & other infectious diseases blood products
 No check of safety measures in installations/fabrications etc.No check of safety measures in installations/fabrications etc.
 Illegal imports in person of hand carry/portable devicesIllegal imports in person of hand carry/portable devices
 No proper presentations ofNo proper presentations of MADE IN PAKISTANMADE IN PAKISTAN
 Misbranded/substandard imports/usageMisbranded/substandard imports/usage
 A vacuum in health claims/facilitiesA vacuum in health claims/facilities
 Loss of revenue/resourcesLoss of revenue/resources
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13. ScopeScope
 OverOver 1 Million1 Million medical devices to be regulatedmedical devices to be regulated
 Spectacles/cardiac stents/pace makers –Spectacles/cardiac stents/pace makers – the lawful use & safetythe lawful use & safety
 Laproscopy machines/Lab & clinical machines –Laproscopy machines/Lab & clinical machines – proper calibrationproper calibration
 Machines used in drug manufacturing –Machines used in drug manufacturing – Standard productionsStandard productions
 Home use/personal use devices –Home use/personal use devices – to get qualityto get quality products with warrantyproducts with warranty
 Regulate devices for imports/Exports –Regulate devices for imports/Exports – improves Country imageimproves Country image
 Meet WHO/ISO parametersMeet WHO/ISO parameters
 Pioneers in south AsiaPioneers in south Asia
 A step ahead from India & BangladeshA step ahead from India & Bangladesh
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14. PURPOSEPURPOSE
11stst
time in Pakistan Medical Devices are coming under comprehensivetime in Pakistan Medical Devices are coming under comprehensive
MEDICAL DEVICES RULES 2015MEDICAL DEVICES RULES 2015 TO :TO :
 PROTECT PUBLIC HEALTHPROTECT PUBLIC HEALTH
 PROTECT PEOPLE FROM UNSAFE, SUB STANDARD, FAKE,PROTECT PEOPLE FROM UNSAFE, SUB STANDARD, FAKE,
SPORIOUS & NON FUNCTIONAL MEDICAL DEVICESSPORIOUS & NON FUNCTIONAL MEDICAL DEVICES
 Prevent reuse of disposable medical devicesPrevent reuse of disposable medical devices
 Minimize blood born infectious diseases AID,HEPATITIS(A,Minimize blood born infectious diseases AID,HEPATITIS(A,
B ,C)B ,C)
VIRAL HEMORRHGIC FEVER, SEPTICEMIAVIRAL HEMORRHGIC FEVER, SEPTICEMIA
 PROVIDE SAFE & EFFECTIVE MEDICAL DEVICESPROVIDE SAFE & EFFECTIVE MEDICAL DEVICES
 ADEHERENCE TO ISO, WHO,IMDRF,GMDN STANDARDSADEHERENCE TO ISO, WHO,IMDRF,GMDN STANDARDS
 IMPROVE EXPORT – GENERATE MORE REVENUEIMPROVE EXPORT – GENERATE MORE REVENUE
 MINIMIZE IMPORT – SELF RELIANCE – NATIONAL GROWTHMINIMIZE IMPORT – SELF RELIANCE – NATIONAL GROWTH

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15. MEDICAL DEVICES RULES 2015MEDICAL DEVICES RULES 2015 -- INDEXINDEX
Chapter TOPIC Rules # Page
s
1. Terminology , Clarification & Definitions 1-2 1-7
2. Conformity Assessment Procedure 3-45 7-28
3. Registration of Conformity Assessment Body (CAB) 46-54 28-31
4. Requirements for Registration of CAB 55-68 31-42
5. Establishment license (Manufacturing & Import) 69-76 42-48
6. Classification of Medical Devices 77-83 48-58
7. Grouping of Medical Devices 84-85 58 - 64
8. Registration of Medical Devices 86-93 64 - 70
9. Import & Export of Medical Devices 94-113 70 -76
10. Labeling of Medical Devices 114-121 77 -80
11. Responsibilities & Obligations 121-127 80 -81
12. Exemptions , Prohibitions and Sampling 128-130 81 -82
13. Usage , Operation , Maintenance Etc 131-134 82 - 85
14. MEDICAL DEVICE BOARD (MDB) 135 85-87
15. Appeal 136 87
16. Medical Device Register (MDR) 137 87
17. FEE 138 87-88
18 Advertising of Medical Devices 139-141 88-90
19. Miscellaneous 142-146 90
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16. TerminologyTerminology
MDB – Medical Device Board CAB –Conformity Assessment BodyMDB – Medical Device Board CAB –Conformity Assessment Body
MD – Medical Devices MDR – Medical Devices RegisterMD – Medical Devices MDR – Medical Devices Register
 CA C – ConforCA C – Conformity Assessment Certificate GDP – Good Distribution Practicesmity Assessment Certificate GDP – Good Distribution Practices
 GSP – Good Storage Practices GLP – Good Laboratory PracticesGSP – Good Storage Practices GLP – Good Laboratory Practices
 GMP – Good Manufacturing Practices GDMN – Global Medical DevicesGMP – Good Manufacturing Practices GDMN – Global Medical Devices
NomenclatureNomenclature
 AHWP – Asian Harmonization Working Party IVD – In Vitro DiagnosticsAHWP – Asian Harmonization Working Party IVD – In Vitro Diagnostics
 IMDRF – International Medical Devices Forum IMD – Invasive Medical DevicesIMDRF – International Medical Devices Forum IMD – Invasive Medical Devices
 DRAP ACT – Drug Regulatory Authority of Pakistan Act 2012 (XXI of 2012)DRAP ACT – Drug Regulatory Authority of Pakistan Act 2012 (XXI of 2012)

MDB
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17. ??
MDBMDB
MEDICAL DEVICE BOARDMEDICAL DEVICE BOARD
MDB

18. Medical Device Board -Medical Device Board -
MDBMDB
CHAIRMANCHAIRMAN
SecretarySecretary
MEMBERSMEMBERS
((D.G.HEALTHS – ProvincialD.G.HEALTHS – Provincial )) (6)(6)
Urologist/Nephrologist (1) Pharmacists (2) Biomedical EngineerUrologist/Nephrologist (1) Pharmacists (2) Biomedical Engineer
(1)(1)
Hospital Pharmacist (1) Radiologist (1) Electromechanical EngineerHospital Pharmacist (1) Radiologist (1) Electromechanical Engineer
(1)(1)
Cardiovascular Surgeon (1) Pathologist (1) General/OrthopedicCardiovascular Surgeon (1) Pathologist (1) General/Orthopedic
Surgeon (1)Surgeon (1)
………………………………………………………………………………………………………………………………………………………………………………………………………………………………
………………
MDB

19. MDBMDB -- DDetailsetails
 CHAIRMAN, secretary & DG Health are EX Officio membersCHAIRMAN, secretary & DG Health are EX Officio members
 Other members are nominated for 2 yearsOther members are nominated for 2 years
 Chairman himself OR on direction of Authority may call meetingChairman himself OR on direction of Authority may call meeting
 In absence of chairman members may elect any member to presideIn absence of chairman members may elect any member to preside
 Quorum to conduct meeting shall be one half of total membersQuorum to conduct meeting shall be one half of total members
 No act or proceeding of MDB shall be invalidNo act or proceeding of MDB shall be invalid merely on the ground ofmerely on the ground of
the existing of any vacancy in ,or any defect in its constitutionthe existing of any vacancy in ,or any defect in its constitution
 MDB may appoint a panel of experts or inspectors for inspection of firmMDB may appoint a panel of experts or inspectors for inspection of firm
 MDB shall follow policy guidelines issued by the policy board ofMDB shall follow policy guidelines issued by the policy board of
authorityauthority
 Where MDB requires examination or evaluation of applications a subWhere MDB requires examination or evaluation of applications a sub
Committee will examine & give report to MDB.Committee will examine & give report to MDB.
 Sub CommitteeSub Committee members(members( SecretarySecretary MDB,MDB, Deputy DirectorDeputy Director MedicalMedical
Devices & Medicated cosmeticsDevices & Medicated cosmetics , Expert member(s), Expert member(s) nominated by MDBnominated by MDB
MDB

20. MDBMDB -- MainMain
RESPONSIBILITIESRESPONSIBILITIES
Registration AuthorityRegistration Authority
For registration of Conformity Assessment Bodies (For registration of Conformity Assessment Bodies ( CAB’sCAB’s))
For registration ofFor registration of Medical DevicesMedical Devices
For Renewal/suspension/cancellation the registrationFor Renewal/suspension/cancellation the registration
 Licensing AuthorityLicensing Authority
To approveTo approve license for manufacturinglicense for manufacturing of Medical devicesof Medical devices
To Renew /suspend/cancel the licenseTo Renew /suspend/cancel the license
 Authority for issuance ofAuthority for issuance of
ImportImport permit for importing Medical Devicespermit for importing Medical Devices
ExportExport permit for export of Medical Devicespermit for export of Medical Devices
Renewal/suspension/cancellation of permitRenewal/suspension/cancellation of permit
 Authority toAuthority to
Ensure implementationEnsure implementation of Medical Devices Rulesof Medical Devices Rules
Check, inspect, investigate or validateCheck, inspect, investigate or validate a person/a person/
firms/manufacturers /Establishment /factoryfirms/manufacturers /Establishment /factory
distributor/involved in Medical Devices business &distributor/involved in Medical Devices business &
SEAL/Stop operation/order for Batch withdrawalSEAL/Stop operation/order for Batch withdrawal
of any of above mentioned parties.of any of above mentioned parties.
MDB

21. FORMATSFORMATS
FORM
NO
PURPOSE Rules applied
1 Application for registration/renewal of CAB 47/1, 49/1, 50/2
2 Certificate of registration of CAB in MDB 48/3
3 Application for grant/renewal of license (manufacturing) 70/2, 73/1, 74/3
3-A Application for grant/renewal of license (Imports) - do -
4. License to manufacture Medical Devices 71/2
4-A License to import Medical Devices 71/2
5. Warranty under medical devices rules 2015
72(2i/4b), 92/7, 124/1i
6. Application for Registration/Renewal of MD (Local
MFG.)
87/2.89/1, 90/2
6-A Application for Registration/Renewal of imported MD’s - do -
7 Certificate of registration of MD (Locally manufactured) 88/4
7-A Certificate of Registration of MD (imported) - do -
8. Intimation regarding import (LC, Qty, rate, parties etc) 94/b
9 Application for import permit(MD/component/material) 96/1
10. MOU (to be attached with application for import) - do -
MDB

22. FORMATSFORMATS
FORM
No
PURPOSE Rules
Applied
11. Application for Import Permit for MD(Clinical analysis) 96/2
12. IMPORT PERMIT (MD’s/component/raw materials) 96/3
13. Import Permit of MD’s (for clinical analysis/ test) - d0 -
14. Intimation of arrival of MD’s/component/raw materials 101/1b
15. Application FORM for EXPORT PERMIT of MD 104/3
16. EXPORT PERMIT for Medical Devices 105/1
17. Application for Export of small quantties of MD for
(Clinical investigation/testing/examination/analysis)
106/1
18. Export permit for small quantities (as shown in 17) 106/3
19. MEDICAL DEVICE REGISTER (MDR)- at MDB 137
20. Application for approval of advertisement of MD’s 140/1
21. PERMISSION to advertise a medical device 140/3
MDB

23. FEE CHARTFEE CHARTCategory Purpose FEE (Rs.)
1 Locally manufactured Medical Devices Registration 20,000
2. - do - Renewal 10,000
3. Imported Medical Devices Registration 1,00,000
4. - do - Renewal 50,000
5 IF imported MD is not manufactured locally Registration 50,000
6 - do - Renewal 25,000
7 - do - (for any change in Regd. MD) Any Change 25,000
8 For Conformity Assessment Body -CAB Registration 1,00,000
9 - do - Renewal 50,000
10 - do - Any Change 50,000
11 Establishment license - ForManufacturing License fee 1.00.000
12 - do - Renewal 50,000
13 - do - Any Change 50,000
14 Establishment License – For Import License fee 20,000
15 - d0 - Renewal 10,000
16 - do - Any Change 10,000
17 Import permit & its Renewal Permit/Renewal 5,000
18 Export permit & its Renewal Permit/Renewal 1,000
19 Appeal Appeal 50,000
20 Advertisement permission Advertise 20,000
21 Miscellaneous - For any other commercial activity MISC. 5,000
FEE
CHART
MDB

24. Exemption Rules - 128 & 146Exemption Rules - 128 & 146
The Conformity Assessment bodies, medical Devices,The Conformity Assessment bodies, medical Devices,
Establishments and Medical Devices specified in table 2Establishments and Medical Devices specified in table 2
below shall , in terms of section 36 of the Act, bebelow shall , in terms of section 36 of the Act, be
exemptedexempted
from its commencement for a period as specified infrom its commencement for a period as specified in
columncolumn
3 thereof, namely (3 thereof, namely (Pease see table on last slidePease see table on last slide ))
The provisions ofThe provisions of the rules made under the Drugs Actthe rules made under the Drugs Act ,,
1976 (XXXI of 1976)1976 (XXXI of 1976) so far as they regulate medicalso far as they regulate medical
devices and their directives covered under these rulesdevices and their directives covered under these rules
areare hereby repealedhereby repealed from the dates and in respect of thefrom the dates and in respect of the
medical devices and activities thereof specifies undermedical devices and activities thereof specifies under
rule 128rule 128
Rule
128
Rule
146
MDB

25. ExemptionsExemptions in Medical Devices Rule – 2015 (in Medical Devices Rule – 2015 ( Rule 128Rule 128 ))
#
(1)
Category
(2)
Time
Period
(3)
Approx
Dates
(4)
1 Conformity Assessment Bodies (CAB’s) 6
months
6.9.2015
2 Class D Medical Devices (Manufacturer/Importers) 1 year 6.3.2016
3 Class C Medical Devices
(Manufacturers/importers)
1.5 year 6.9.2016
4 Class A-MD(Active , sterile or having measuring
function)
(Manufacturer/Importer)
2 years 6.3.2017
5 Class B Medical Devices
(Manufacturers/Importers)
2 years 6.3.2017
MDB

26. ??
CABCAB
CCONFORMITYONFORMITY AASSESSMENTSSESSMENT
BBODYODY
CA
B
MDB

27. Conformity Assessment BodiesConformity Assessment Bodies
 A private technical body (Person/firm)A private technical body (Person/firm)
 Duly registered with MDBDuly registered with MDB
 Having expertiseHaving expertise in Judging Quality Parameters of Medical Devicesin Judging Quality Parameters of Medical Devices
 A sound organization with adequate competent staff & appropriateA sound organization with adequate competent staff & appropriate
facilities, test equipment to carry conformity test of Med devicesfacilities, test equipment to carry conformity test of Med devices
BASIC FUNCTIONsBASIC FUNCTIONs
 A legal supportive bodyA legal supportive body established under Medicalestablished under Medical
DevicesDevices
Rules 2015 (Rule 46-48)Rules 2015 (Rule 46-48)
 AnAn independentindependent, fully responsible , technically competent, fully responsible , technically competent
to perform conformity assessments of medical devicesto perform conformity assessments of medical devices
asas
per rules &per rules & submit reportsubmit report to MDB in specified time.to MDB in specified time.
 Confidentiality is mandatoryConfidentiality is mandatory for CAB. No detail/record orfor CAB. No detail/record or
results should be disclosed to any party except MDBresults should be disclosed to any party except MDB
CA
B

28. CAB - DUTIESCAB - DUTIES
CONFORMITY ASSESSMENT OF :CONFORMITY ASSESSMENT OF :
 QMS (Quality Management System)QMS (Quality Management System)
of applicant for registration of deviceof applicant for registration of device
 PMSS (Post Market Surveillance System) as per device claimsPMSS (Post Market Surveillance System) as per device claims
 Technical documentsTechnical documents
 Declaration of conformityDeclaration of conformity
CA
B

29. Selection & registration with Conformity Assessment BodySelection & registration with Conformity Assessment Body
 3 types can apply (manufacturer/importer or rep/distributor)
Procedure
 Select any party from approved list by MDB
 CAB should not be related to the firm/person
 Provide /allocate/display your product /device for assessment
 Give all necessary information of device
 Provide QMS data of medical device (if applicable) as follows :
Manufacturer : ISO 13485 –Medical Devices QMS (for regulatory)
Importer/Rep : GDPMD (Ask manufacturer)-approval by CAB/ MDB
Distributor : GDPMD (Good Distribution Practices of Medical devices)
For Foreign Concerns ( company/firm/Person )
 Authorize a person/firm in Pakistan
 Provide relevant documents/requirements (QMS)
 Get CAB validation/conformity of QMS/documents
/Evidence etcas per procedure mentioned above
Exemption from
CAB registration is
applicable on
certain foreign
firms as per rule
142 (1) a
CA
B

30. TITLETITLE
MEDICALMEDICAL
DEVICESDEVICES
MDCA
B

31. Classification of MedicalClassification of Medical
DevicesDevices
 Clarification of terms/words whether mentioned or not is theClarification of terms/words whether mentioned or not is the
exclusive & Discrete right of DRAP under DRAP ACTexclusive & Discrete right of DRAP under DRAP ACT
 In case of dispute/misunderstanding between CAB & firm aboutIn case of dispute/misunderstanding between CAB & firm about
classification of a medical deviceclassification of a medical device MDB will decideMDB will decide on writtenon written
request of either party & inform both the partiesrequest of either party & inform both the parties
Categories/TypesCategories/Types
 Non invasive/Invasive
 Implantable/Non implantable
 IVD’s (diagnostics)
 Life supporting/sustaining
 Self testing/adminsitration
 Service providing
 Reusable surgical instruments
 Special access tools/machines (Custom made)
 Surgical invasive MD
MD

32. Classification –Non Invasive (NIMD)Classification –Non Invasive (NIMD)
Non Invasive -1Non Invasive -1( Derma related)( Derma related)
 AA – Simple wound dressings . cotton wool etc– Simple wound dressings . cotton wool etc
 BB – non medicated impregnated gauze dressings .etc– non medicated impregnated gauze dressings .etc
 CC – Dressings for - severe burns or chronic ulcerated wounds– Dressings for - severe burns or chronic ulcerated wounds
etcetc
Non Invasive-2Non Invasive-2
 AA – Administration set( Gravity infusions)/syringes– Administration set( Gravity infusions)/syringes (No needle)(No needle)
 BB –– Syringes/sets for infusion pumps/anesthesia/bSyringes/sets for infusion pumps/anesthesia/b reathing circuitsreathing circuits
etcetc
Tubes used for blood transfusion , organ storageTubes used for blood transfusion , organ storage
containerscontainers
Blood bags that do not incorporate an anti coagulant etcBlood bags that do not incorporate an anti coagulant etc
 CC – blood bags– blood bags
NON INVASIVE - 3NON INVASIVE - 3
 AA – Urine collection bottles/compression hosiery– Urine collection bottles/compression hosiery
 Non Invasive electrodes , hospital bedsNon Invasive electrodes , hospital beds
 BB – devices to remove carbon dioxide– devices to remove carbon dioxide
Particulate filters in extracorporial circulation system etcParticulate filters in extracorporial circulation system etc
MD

33. Classification – INVASIVE (IMD)Classification – INVASIVE (IMD)
Examination gloves/enema devices ETC.Examination gloves/enema devices ETC.
Dentures to be removed/Dressings for nasal bleedingDentures to be removed/Dressings for nasal bleeding
Urinary catheters/tracheal tubes/orthodontic wireUrinary catheters/tracheal tubes/orthodontic wire
Dental prosthesis (fix)Dental prosthesis (fix)
Urethral stents , contact lenses etc
manually operated surgical drills/bits & saw etc
Syringe needles/lancets, single use scalpets , surgical
staplers
Single aortic punch , surgical gloves ,
catheters/suckers etc
Surgical instruments (sterile/single use) other than
class D
Catheters containing sealed radioisotopes/insulin
pen etc
Invasive
1
Invasive
2A
B
C
D
A
B
C
MD

34. B – Infusion Canola , Temporary filling materials ,
Tissue stabilizers(CV)
Skin closure devices (non absorbable)
C – Surgical adhesives/brachy therapy device etc
D – Absorbable sutures/biological adhesives
Neurological & CV catheters
Carotid artery shunts ,
Pacemaker lead (temporary) etc
Invasive
3
B
C
D
MD

35. Classification –Implantable Medical DevicesClassification –Implantable Medical Devices
BRIDGES/CROWNS/DENTAL FILLING MATERIALSBRIDGES/CROWNS/DENTAL FILLING MATERIALS
Implants used in :Implants used in :
Orthopedic /dental/ophthalmic/CV fieldsOrthopedic /dental/ophthalmic/CV fields
Maxilla-facial implants , prosthetic joint replacementMaxilla-facial implants , prosthetic joint replacement
Bone cement , Internal sutures (non absorbable) etcBone cement , Internal sutures (non absorbable) etc
Rechargeable non active drug delivery systemRechargeable non active drug delivery system
etcetc
Prosthetic heart valves , spinal/vascularProsthetic heart valves , spinal/vascular
stentsstents
Pace makers & theirPace makers & their
electrodes/leadselectrodes/leads
ImplantableImplantable
defibrillators etcdefibrillators etc
BioactiveBioactive
implants etcimplants etc
B
C
D
MD

36. Classification – Active Medical DevicesClassification – Active Medical Devices
MRI equipment , Diagnostic ultrasound , evoked response stimulatorsMRI equipment , Diagnostic ultrasound , evoked response stimulators
Examination lamps , surgical microscopes , powered hospitalExamination lamps , surgical microscopes , powered hospital
beds/chairsbeds/chairs
Powered equipment for recording/processing/viewing of diagnosticPowered equipment for recording/processing/viewing of diagnostic
images , dental curing lightsimages , dental curing lights
Muscle stimulators , powered dental hand pieces , hearing aidsMuscle stimulators , powered dental hand pieces , hearing aids
Neonatal phototherapy equipment , ultrasound equipment (physio)Neonatal phototherapy equipment , ultrasound equipment (physio)
Gamma/Nuclear cameras , electronic thermometers , stethoscope ,Gamma/Nuclear cameras , electronic thermometers , stethoscope ,
BP monitors , ECG etc. Suction equipment , feedinBP monitors , ECG etc. Suction equipment , feedin g pumps , nebuliserg pumps , nebuliser
(safe)(safe)
Lung ventilators , baby incubators , surgical lasers , lithotriptersLung ventilators , baby incubators , surgical lasers , lithotripters
Therapeutic x ray , electrosurgical generators , external pacemakersTherapeutic x ray , electrosurgical generators , external pacemakers
External defibrillators etc. equipment used for ionizing radiation etcExternal defibrillators etc. equipment used for ionizing radiation etc
ICU monitors/alarms , Apnoea monitors ,biological sensors , oxygenICU monitors/alarms , Apnoea monitors ,biological sensors , oxygen
Saturation monitors , ultrasound equipment (CCU) , infusion pumpsSaturation monitors , ultrasound equipment (CCU) , infusion pumps
Anesthesia & dialysis equipment , hyperbaric chambers , nebulizersAnesthesia & dialysis equipment , hyperbaric chambers , nebulizers
(risk)(risk)
B
A
C
MD

37. Classification of Medical Device – AdditionalClassification of Medical Device – Additional
methodmethod
Manufactured from non-viable animal tissues or their derivatives &touchManufactured from non-viable animal tissues or their derivatives &touch
with intact skin only (leather components of ortho paedic appliances etc.with intact skin only (leather components of ortho paedic appliances etc.
Intended for disinfecting medical devices prior to sterilization or higherIntended for disinfecting medical devices prior to sterilization or higher
level disinfection e.g. washer disinfectorslevel disinfection e.g. washer disinfectors etcetc
Intended for sterilization/disinfection of Medical devices as end pointIntended for sterilization/disinfection of Medical devices as end point
processing e.g. MD for sterilizing endoscopes , disinfectants with MD etcprocessing e.g. MD for sterilizing endoscopes , disinfectants with MD etc
Intended for disinfecting/cleaning/rinsing/hydrating contact lenses.Intended for disinfecting/cleaning/rinsing/hydrating contact lenses.
Used for contraception ,STD prevention (condoms ,contraceptiveUsed for contraception ,STD prevention (condoms ,contraceptive
diaphragmsdiaphragms
Antibiotic bone cement , heparin coated catheters , Antimicrobial woundAntibiotic bone cement , heparin coated catheters , Antimicrobial wound
dressings , blood bags(anticoagulants) , manufactured from human/animaldressings , blood bags(anticoagulants) , manufactured from human/animal
cells/tissues & their derivatives as well (viable or not) e.g. porcine heartcells/tissues & their derivatives as well (viable or not) e.g. porcine heart
valves , catgut sutures etc.valves , catgut sutures etc.
A
B
C
D
MD

38. Classification – In Vitro Diagnostic Medical Devices – (IVD)Classification – In Vitro Diagnostic Medical Devices – (IVD)
Reagents/others articles/Instruments used for IVD proceduresReagents/others articles/Instruments used for IVD procedures
Specimen receptacles (wash solutions , instruments & plain urine cupSpecimen receptacles (wash solutions , instruments & plain urine cup
Identification kits for cultured microorganismsIdentification kits for cultured microorganisms
Self testing devices (pregnancy test/urine test stripes/fertility testing etc)Self testing devices (pregnancy test/urine test stripes/fertility testing etc)
All IVD devices not covered in A , C , D e.g. blood gases , metabolicAll IVD devices not covered in A , C , D e.g. blood gases , metabolic
markersmarkers
H. Pylori & physiological markers such as hormones/vitamins/enzymesH. Pylori & physiological markers such as hormones/vitamins/enzymes
All IVD devices controlled without qualitative/quantitative valueAll IVD devices controlled without qualitative/quantitative value
Intended for :Intended for :
Detection of presence of or exposure to a transmissible agent inDetection of presence of or exposure to a transmissible agent in
blood ,blood ,
blood components/blood derivatives/cells/tissues/organs to acessblood components/blood derivatives/cells/tissues/organs to acess
suitability of transfusion/transplant etcsuitability of transfusion/transplant etc
Tests for HIV ,HCV ,HBV , HTLVTests for HIV ,HCV ,HBV , HTLV
All types of assays (first line/confirmatory/supplemental)All types of assays (first line/confirmatory/supplemental)
Used for ABO , rhesus (C ,c ,D , E , e) & anti-kell determinationUsed for ABO , rhesus (C ,c ,D , E , e) & anti-kell determination
A
B
D
MD

39. CLASSIFICATION - IVDCLASSIFICATION - IVD
Used for :Used for :
Blood grouping , tissue typing , e.g. HLA , anti – Duffy , anti KiddBlood grouping , tissue typing , e.g. HLA , anti – Duffy , anti Kidd
Detection of presence/exposure to STD’sDetection of presence/exposure to STD’s
Detection of infectious agent in cerebrospinal fluid or bloodDetection of infectious agent in cerebrospinal fluid or blood
Diagnostic assay for CMV , Chlamydia pneumoniae , MRSADiagnostic assay for CMV , Chlamydia pneumoniae , MRSA
Pre natal screening (Immune status test for rubella/ toxoplasmosisPre natal screening (Immune status test for rubella/ toxoplasmosis
Detection of infective disease/ immune status e.g. CMV/HSV in transplantsDetection of infective disease/ immune status e.g. CMV/HSV in transplants
Screening of disease stage or diagnosis of cancer e.g. personalizedScreening of disease stage or diagnosis of cancer e.g. personalized
medicinesmedicines
Human genetic testingHuman genetic testing
Monitoring levels of medicinesMonitoring levels of medicines
Management of patients suffering from life threatening diseasesManagement of patients suffering from life threatening diseases
Screening for congenital disorders in fetus (spina bifida/down syndrome)Screening for congenital disorders in fetus (spina bifida/down syndrome)
Intended for :Intended for :
self testing e.g. blood glucose monitoringself testing e.g. blood glucose monitoring
Blood gases & blood glucose determinations for near- patient testingBlood gases & blood glucose determinations for near- patient testing
c
MD

40. CODING OF MEDICAL DEVICESCODING OF MEDICAL DEVICES
Category of Medical Device Principal
code
Sub codes
Non Active – Non Implantable MD-0100 0101-0109
Non Active Implants MD-0200 0201-0204
DEVICES FOR WOUND CARE MD-0300 0301-0303
NON ACTIVE DENTAL DEVICES/ACCESSORIES MD-0400 0401-0403
GENERAL ACTIVE MEDICAL DEVICES MD-1100 1101-1111
DEVICES FOR IMAGING MD-1200 1201-1202
MONITORING DEVICES MD- 1300 1301-1302
RADIATION/THERMO THERAPY DEVICES MD-1400 1401-1404
ACTIVE IMPLANTABLE DEVICES (AIMD) AIMD-0100 0101-0103
IVD – REAGENTS/PRODUCTS FOR BLOOD GROUPS IVD-0100 0101-0103
IVD –REAGENTS/PRODUCTS FOR DETECTION OF
MARKERS
IVD-0200 0201-0203
IVD – REAGENTS/PRODUCTS FOR SELF DIAGNOSIS IVD-0300 0301-0309
IVD – DEVICES FOR SELF TESTING IVD-0400 0401-0406
SPECIFIC & ACTIVE MEDICAL DEVICES (MDS/AIMD) MDS-7000 7001-7005
SPECIFICS OF IVD MDS-7200 7206-7210
MD

41. MDMD
RegistrationRegistration
ofof
Medical DevicesMedical Devices
Registration
MD

42. MEDICAL DEVICESMEDICAL DEVICES
REGISTRATIONREGISTRATION
STEP - ISTEP - I
 Establish a firm (Sole proprietor/partnership/private Ltd) – optionalEstablish a firm (Sole proprietor/partnership/private Ltd) – optional
 Declare the firm as manufacturer/importer/exporter/distributor/RepDeclare the firm as manufacturer/importer/exporter/distributor/Rep
 Get the firm registered with registrar of firmsGet the firm registered with registrar of firms
 Get NTN no of firmGet NTN no of firm
 Get drug license (if applicable)Get drug license (if applicable)
 Apply for trade mark patent registration (Firm/Device)- optionalApply for trade mark patent registration (Firm/Device)- optional
STEP -IISTEP -II
 Select the category of device & its code from list of MDBSelect the category of device & its code from list of MDB
 Appoint /select CAB (conformity assessment body registered by MDB)Appoint /select CAB (conformity assessment body registered by MDB)
 Provide the dossier(s) of the Medical Device(s)Provide the dossier(s) of the Medical Device(s)
 Get conformity assessment certificate (registration) of device with CABGet conformity assessment certificate (registration) of device with CAB
 Apply for Manufacturing license or import/export permit from MDBApply for Manufacturing license or import/export permit from MDB
STEP – IIISTEP – III
 Complete the required documentation by MDBComplete the required documentation by MDB
 Prepare the Dossier (CSDT) . Attach the relevant documentsPrepare the Dossier (CSDT) . Attach the relevant documents ..
 Deposit the fee (as per MDB list).Deposit the fee (as per MDB list).
 Submit the dossier to MDB for registration of deviceSubmit the dossier to MDB for registration of device
Registration

43. MEDICAL DEVICESMEDICAL DEVICES
dd
DOSSIER

44. DOSSIER of Medical DevicesDOSSIER of Medical Devices
CSDTCSDT -- CCommonommon SSuubmissionbmission DDossierossier TTemplateemplate
1. To be submitted by manufacturer for conformity assessment1. To be submitted by manufacturer for conformity assessment
2. As a summary of the technical documents of Medical Device2. As a summary of the technical documents of Medical Device
3. Contains the3. Contains the ElementsElements as per rules 30-45as per rules 30-45
4. Where Elements not applicable (NA) – provide justification for NA4. Where Elements not applicable (NA) – provide justification for NA
Classification of MDClassification of MD
Complexity of MDComplexity of MD
New /Existing category of MDNew /Existing category of MD
High risk/hazardous/Adverse effects/useHigh risk/hazardous/Adverse effects/use
errorserrors
Any specific public health concern of MDAny specific public health concern of MD
 Support documents should beSupport documents should be
 Legible/Valid/submitted in fullLegible/Valid/submitted in full
 Duly signed & stamped by authorized personDuly signed & stamped by authorized person
 Attached as annexureAttached as annexure
Basics
Details
Support
DOSSIE
R

45. Elements of DOSSIERElements of DOSSIER -- CSDTCSDT
 Executive summaryExecutive summary -- ((Introductory description/history/uses/evidence/safety)Introductory description/history/uses/evidence/safety)
 Essential principles/RulesEssential principles/Rules -- (Relevant & to demonstrate conformity – see(Relevant & to demonstrate conformity – see Rule 31Rule 31))
 Description of MDDescription of MD (Mode of action/label claims/Risk(Mode of action/label claims/Risk
class/configurations/accessory)class/configurations/accessory)
 Summary of Design/ValidationSummary of Design/Validation --(Biocompatibility/software/Eng. & lab tests etc /CAC)(Biocompatibility/software/Eng. & lab tests etc /CAC)
 Pre clinical studiesPre clinical studies -- (see rule 34)(see rule 34)
 Software ValidationSoftware Validation -- (Supportive documents of testing /results/validation etc)(Supportive documents of testing /results/validation etc)
 Clinical EvidenceClinical Evidence (Systemic review/clinical experience/ clinical(Systemic review/clinical experience/ clinical
investigations)investigations)
 Existing bibliographyExisting bibliography (From relevant publications/peer reviewed scientific Lit. etc)(From relevant publications/peer reviewed scientific Lit. etc)
A
B
DOSSIE
R

46. Elements of DOSSIERElements of DOSSIER -- CSDTCSDT
 MD labelingMD labeling (Instructions for use/install/maintain/training/guidance etc)(Instructions for use/install/maintain/training/guidance etc)
 Risk analysisRisk analysis (risk management report-RPR/as per MDB approved(risk management report-RPR/as per MDB approved
standards )standards )
 Manufacturing info.Manufacturing info. ( Mfg. process/QC/QA/List of resources & procedures)( Mfg. process/QC/QA/List of resources & procedures)
 Special requirementSpecial requirement for MD used for clinical investigation (seefor MD used for clinical investigation (see rule 42rule 42))
Declaration of conformityDeclaration of conformity (( CACCAC)) (fulfils requirements of DRAP Act/MDR 2015)(fulfils requirements of DRAP Act/MDR 2015)
C
Mandatory
DOSSIE
R

47. LicensesLicenses
Establishment LicenseEstablishment License
MANUFACTURINGMANUFACTURING
Manufacturing

48. EstablishmentEstablishment LicenseLicense
Application to be onApplication to be on FORM -3FORM -3 & addressed to secretary MDB& addressed to secretary MDB
Applicant should be Pakistani NationalApplicant should be Pakistani National
Applicant should beApplicant should be registeredregistered withwith CABCAB
Separate application forSeparate application for each premiseseach premises (if more than one)(if more than one)
FeeFee deposit is mandatory (see rule 138)deposit is mandatory (see rule 138)
BASIC
S
Manufacturin
g

49. EstablishmentEstablishment LicenseLicense
Receipt of application in MDBReceipt of application in MDB
Inspection of premises (may be or may not be)Inspection of premises (may be or may not be)
Appointment of expert panel by MDB(inspectors/auditors of CAB)Appointment of expert panel by MDB(inspectors/auditors of CAB)
Satisfactory report of panel submittedSatisfactory report of panel submitted
to MDBto MDB
Issuance of license onIssuance of license on
FORM – 4FORM – 4
Entry of license in MDR (Medical Devices
Register)
Renewal after 5 years from
date of issue
Provincial Governments in accordance with section 6 of the
Procedur
e
Note
Manufacturin
g

50. General conditions for LicenseGeneral conditions for License
Appropriate premisesAppropriate premises
AdequateAdequate
equipmentequipment
 Production in chargeProduction in charge Pharmacist/Bio Med. EngineerPharmacist/Bio Med. Engineer Full timeFull time
employeesemployees
 Quality Control In charge- a pharmacistQuality Control In charge- a pharmacist Have 2 yearsHave 2 years
samesame
 Proper medical coverage of employeesProper medical coverage of employees categorycategory
experienceexperience
..
Display license on a visible place in premisesDisplay license on a visible place in premises
Keep proper record of each batchKeep proper record of each batch
License is the
property of
MDB
Manufacturin
g

51. General conditions for LicenseGeneral conditions for License
Visits of inspector/Rep ofVisits of inspector/Rep of MDB to any premisesMDB to any premises mentionedmentioned
Provide all documents on demand by inspector/Rep of MDBProvide all documents on demand by inspector/Rep of MDB
Withdrawal/cease sales of stocks if any batch rejected by MDBWithdrawal/cease sales of stocks if any batch rejected by MDB
Compliance of GMP/GDP/GSPCompliance of GMP/GDP/GSP
EnvironmentalEnvironmental compliancecompliance
Ventilation/wastageVentilation/wastage
disposal/toilets etcdisposal/toilets etc
License is Non
transferable without
MDB permission
Manufacturing

52. RenewalRenewal of Manufacturingof Manufacturing
LicenseLicense
Application to MDB (FORM 3) – 60 days before expiry of licenseApplication to MDB (FORM 3) – 60 days before expiry of license
Application feeApplication fee
Documents as per form-3 requirementDocuments as per form-3 requirement
Certificate of conformity by CAB (where applicable)Certificate of conformity by CAB (where applicable)
MDB - verification/visits/Panel Report/CAB report etc (if applicable)MDB - verification/visits/Panel Report/CAB report etc (if applicable)
MDB – Recommendations /ApprovalMDB – Recommendations /Approval
Issuance of Renewal license for next 5 years from previous expiry dateIssuance of Renewal license for next 5 years from previous expiry date
 10% (of renewal fee) per day if10% (of renewal fee) per day if applied within 60 days after expiry dateapplied within 60 days after expiry date
 License is valid ifLicense is valid if applied before expiry OR 60 days after expiry with fine paidapplied before expiry OR 60 days after expiry with fine paid
 License cease to existLicense cease to exist if appliedif applied after 60 days of date of expiryafter 60 days of date of expiry &&
 Application will be treated as fresh one (Application will be treated as fresh one ( new license rules will applynew license rules will apply ))
Procedur
e
Penalty
Manufacturin
g

53. Change(s)Change(s) in Particulars ofin Particulars of
LicenseLicense
Changes includesChanges includes BUT not limitedBUT not limited to one or more of theto one or more of the
following :following :
 PremisesPremises
 Quality system(s)Quality system(s)
 CABCAB
 Class, category ,code of medical deviceClass, category ,code of medical device
ApplicationApplication
on form – 3on form – 3
Fee deposit as perFee deposit as per
fee schedulefee schedule
Verification/inspection/visits/panel views byVerification/inspection/visits/panel views by
MDBMDB
Recommendations/reports by CAB/REPRecommendations/reports by CAB/REP
of MDBof MDB
Procedure
Chang
e
Manufacturing

54. Cancellation/suspension of LicenseCancellation/suspension of License
 Non compliance of MD rules 2015Non compliance of MD rules 2015
 AnyAny violationviolation of MD rules 2015of MD rules 2015
 Wrong information in applicationWrong information in application
 Non compliance of Inspection/visits/notes orNon compliance of Inspection/visits/notes or corrective measurescorrective measures
 The circumstances at time of issuance do not exist nowThe circumstances at time of issuance do not exist now
 Necessary in vitalNecessary in vital public interestpublic interest
 License obtained by fraud or misrepresentationLicense obtained by fraud or misrepresentation
 Written complaint(s) & verified by MDB/CAB or REP of MDBWritten complaint(s) & verified by MDB/CAB or REP of MDB
 Any Violation of DRAP ACTAny Violation of DRAP ACT
Reasons
Manufacturing

55. Cancellation/suspension of LicenseCancellation/suspension of License
 LodgingLodging of written complaintof written complaint
 Verification of authenticity of complaint by MDBVerification of authenticity of complaint by MDB
 Show causeShow cause notice to the licensee (in writing)notice to the licensee (in writing)
 ReplyReply to show cause notice by licensee within 14 days from date of issueto show cause notice by licensee within 14 days from date of issue
 HearingHearing (to give an opportunity to the Licensee to clarify/satisfy MDB(to give an opportunity to the Licensee to clarify/satisfy MDB
 Decision by MDBDecision by MDB to suspend/cancel the licenseto suspend/cancel the license
 GrievancesGrievances (if any) of licensee regarding QC lab tests/reports will be(if any) of licensee regarding QC lab tests/reports will be
addressed by sending the case with samples (lying with MDB) to theaddressed by sending the case with samples (lying with MDB) to the
Appellate lab set/notified by the authority for final/conclusive verdicAppellate lab set/notified by the authority for final/conclusive verdic tt
 Final decisionFinal decision in writing by MDB to cancel/suspend the license(cc toin writing by MDB to cancel/suspend the license(cc to
party)party)
 Return/surrenderReturn/surrender of license to MDB by licensee within 14 days from date Of decision withoutof license to MDB by licensee within 14 days from date Of decision without
demandeman
 All MD’s registrationsAll MD’s registrations under this license will beunder this license will be automatically cancelledautomatically cancelled
Procedure
License is the
property of
MDB
Manufacturing

56. LicensesLicenses
IMPORT LICENSEIMPORT LICENSE
IMPOR
T

57. License for Import of Medical DevicesLicense for Import of Medical Devices
((Issuance/changes/Renewal/suspension/cancellationIssuance/changes/Renewal/suspension/cancellation ))
Procedure/Requirements/documentation/conditionsProcedure/Requirements/documentation/conditions
Same as for manufacturing licenseSame as for manufacturing license BUTBUT
 Apply on FORM 3-AApply on FORM 3-A
 Fee as per schedule of import licenseFee as per schedule of import license
 Need authority letter/Agreement from principal to import/sellNeed authority letter/Agreement from principal to import/sell
 Foreign CAB having certified MD being approved by any of theForeign CAB having certified MD being approved by any of the
regulatory authorities of (regulatory authorities of (USA/Canada/Japan/Australia/Austria/ Belgium/USA/Canada/Japan/Australia/Austria/ Belgium/
Denmark/France/Germany/Italy/UK/Ireland/Sweden/Norway/Spain /SwitzerlandDenmark/France/Germany/Italy/UK/Ireland/Sweden/Norway/Spain /Switzerland
//NetherlandNetherland ) OR pre qualified by) OR pre qualified by WHOWHO – shall be exempted from– shall be exempted from
registration with MDBregistration with MDB
License is the
property of
MDB
License is Non
transferable without
MDB permission
IMPOR
T

58. permitspermits
IMPOTR PERMITIMPOTR PERMIT
IMPOR
T

59. IMPORT PERMIT for MDIMPORT PERMIT for MD
 Valid import license of the company issued by MDBValid import license of the company issued by MDB
 Valid MD registration with MDBValid MD registration with MDB
 Intimation to MDB on form -8 within 15 days after opening LCIntimation to MDB on form -8 within 15 days after opening LC
 A single application/permit for import of more than one MD’s of same firmA single application/permit for import of more than one MD’s of same firm
 Application for import permit on FORM – 9Application for import permit on FORM – 9
 Undertaking/MOU on FORM - 10Undertaking/MOU on FORM - 10
 Application to import small quantities for clinical investigations (Form –Application to import small quantities for clinical investigations (Form –
11)11)
 Permit for import of MD’s for commercial use will be issued on FORM –Permit for import of MD’s for commercial use will be issued on FORM –
1212
 Permit for import of small quantities on FORM – 13Permit for import of small quantities on FORM – 13
 Permit will be issued for a period of 3 yearsPermit will be issued for a period of 3 years
 Permit validity is subject to validity of License & MD’s registrationPermit validity is subject to validity of License & MD’s registration
 Renewal application to be submitted 3 months before expiry dateRenewal application to be submitted 3 months before expiry date
 Previous permit will remain valid till the decision of renewal applicationPrevious permit will remain valid till the decision of renewal application
Basics
IMPOR
T

60. IMPORT PERMITIMPORT PERMIT
 Apply on prescribed formatsApply on prescribed formats
 Attach valid documentary evidenceAttach valid documentary evidence
 Deposit FeeDeposit Fee
 Inspection of premises by MDB/its REP with or without noticeInspection of premises by MDB/its REP with or without notice
 Keep proper record at premises of all the activities regarding desiredKeep proper record at premises of all the activities regarding desired
MD’sMD’s
 Inspection report submission to MDBInspection report submission to MDB
 Evaluation of inspection report & findingsEvaluation of inspection report & findings
 Time frame for corrective measures (if in findings)Time frame for corrective measures (if in findings)
 Final report after taking corrective measures (if applicable)Final report after taking corrective measures (if applicable)
 RecommendationsRecommendations
 Issue of permitIssue of permit
Procedure
IMPOR
T

61. General conditions of import of MDGeneral conditions of import of MD
Each import should accompany :Each import should accompany :
 Test reportTest report of – copy by competent authority of country ofof – copy by competent authority of country of
originorigin
 IntimationIntimation of consignment arrival to clearing authorityof consignment arrival to clearing authority
 AttachAttach 3 copies of invoice3 copies of invoice with intimation (Form 14)with intimation (Form 14)
 UndertakingUndertaking on stamp paper by importer of MD showingon stamp paper by importer of MD showing
MD imported is genuine as per DRAP ACT/RulesMD imported is genuine as per DRAP ACT/Rules
Information given in import is 100% correctInformation given in import is 100% correct
Importer will be solely responsible for wrong declarationImporter will be solely responsible for wrong declaration
Importer will be liable for punishment for violation ofImporter will be liable for punishment for violation of
RulesRules
Custom rules apply as per
RULE 103 of MD rules 2015
for clearance of MD from
port
IMPOR
T

62. Import of MD for personal use – Rule 100Import of MD for personal use – Rule 100
 Small quantities of MD including those the import of which is otherwiseSmall quantities of MD including those the import of which is otherwise
prohibited under the DRAP Act and the rules made there under may beprohibited under the DRAP Act and the rules made there under may be
imported for personal use provided :imported for personal use provided :
 MD is part of personal baggageMD is part of personal baggage
 For exclusive personal requirementFor exclusive personal requirement
 Quantity restricted to personal requirement onlyQuantity restricted to personal requirement only
IF MD is not part of personal baggageIF MD is not part of personal baggage
 Take prior permission from MDBTake prior permission from MDB
 Quantity must be approved by MDB (sufficient to meet the need ofQuantity must be approved by MDB (sufficient to meet the need of
person)person)
For
Personal
use
IMPOR
T

63. PERMITSPERMITS
EXPORT PERMITEXPORT PERMIT
EXPOR
T

64. Export permit for MDExport permit for MD
All terms, conditions, rules, regulationsAll terms, conditions, rules, regulations
&&
procedures for export of MD are almostprocedures for export of MD are almost
same as of Import except thatsame as of Import except that
 Application will be made on FORM – 15Application will be made on FORM – 15
 Export permit will be issued on FORM - 16Export permit will be issued on FORM - 16
EXPOR
T

65. Thanks for your attention!
MEDICA
L RULES
2015