Pharma Regulatory Affairs & Healthcare Ethics

1. Medical Devices Rules, 2017
Rashid Mureed

2. Pakistan Medical Devices Rules,
20172
CHAPTERS
 1. Preliminary
 2. Establishment of License
 3. Classification & Grouping of Medical Devices
 4. Enlistment & Registration of Medical Devices
 5. Import & Export
 6. Labelling of Medical Devices
 7. Responsibilities and Obligations
 8. Exemptions, Prohibition and Sampling
 9. Usage, Operation, Maintenance, Etc.
 10. Medical Devices Board
 11. Appeal
 12. Medical Devices Register
 13. Fee
 14. Advertisement of Medical Devices
 15. Miscellaneous
Medical Devices Rules
2017
22 February 2020

3. Medical Device
3
Defines a medical device as any product that does not achieve its
purposes by chemical action or metabolization.
 As simple as a tongue depressor
 As complex as robotic surgery devices
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Medical Devices Rules
2017

4. Classification “Terms”
4
 Classified
 Un-classified
 Not Classified
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Medical Devices Rules
2017

5. Device Classification
5
 1700 generic groups of devices
 Classified within 16 medical specialties
 862 = Chemistry/Toxicology 878 = General Plastic Surgery
 864 = Hematology/Pathology 880 = General Hospital
 866 = Immunology/Microbiology 882 = Neurological
 868 = Anesthesiology 884 = Obstetrical/Gynecological
 870 = Cardiovascular 886 = Ophthalmic
 872 = Dental 888 = Orthopedic
 874 = Ear, Nose and Throat 890 = Physical Medicine
 876 = Gastro/Urology 892 = Radiology
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Medical Devices Rules
2017

6. Classification System-Risk
Categorization
6
 Class I
General Controls
(adhesive bandage/I.V. stand/sunglasses)
 Class II
General Controls and Special Controls
(syringe/surgical mask/powered wheelchair)
 Class III
General Controls and Premarket Approval
(heart valves/implantable neuromuscular stimulator)
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Medical Devices Rules
2017

7. Summary of Classification
7
 Terminology of device classification will assist in proper
classification
 Correct classification of your device will outline the regulatory
requirements
 Complying with general and special controls will assure timely
review decisions and compliance
 Proper search of the product classification database will achieve
successful results
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Medical Devices Rules
2017

8. Chapter-I
8
1. Short Title and Commencement
2. Definition
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Medical Devices Rules
2017

9. Chapter II- Establishment
License9
3- Type of Establishment License
4- Application Procedure for Establishment License
5- Procedure for grant of establishment license
6- Conditions of establishment license
7- Renewal of establishment license
8- Changes concerning establishment license
9- General conditions for establishment license
10- Cancellation or suspension of establishment license
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Medical Devices Rules
2017

10. Chapter II-
Classification And Grouping Of Medical
Devices10
11- Classification and grouping of medical devices
Medical Devices Rules
2017
22 February 2020

11. CHAPTER IV
ENLISTMENT AND REGISTRATION OF MEDICAL
DEVICES
11
12- Enlistment and registration of medical devices
13- Classes of medical devices for enlistment and registration
14- Procedure for enlistment and registration of medical devices
15- Procedure for grant of certificate for enlistment
16- Renewal of certificate for enlistment and registration of medical
device
17- Changes concerning enlisted or registered medical device
18- Certificate of enlistment or registration of medical device
19- Conditions of enlistment or registration of medical device
20- Cancellation or suspension of enlistment or registration of medical
device
Medical Devices Rules
2017
22 February 2020

12. CHAPTER V
IMPORT AND EXPORT12
21- Import of medical devices
22- Import of small quantities of medical devices, components or raw
materials for clinical investigation or sample for evaluation, etc
23- Conditions of a permit to import small quantities of medical
devices, components or raw materials for clinical investigation or
sample for evaluation, etc.
24- Import of medical devices for personal and hospital’s patient’s use
25- General conditions for import
26- Procedure at customs port
27- Application for export permit
28- Export-permit for medical device
29- Application for export-permit for the purpose of clinical
investigation, examination, test or analysis
Medical Devices Rules
2017
22 February 2020

13. CHAPTER V
IMPORT AND EXPORT13
30- Duration of permit to export medical devices
31- Conditions of export permit
32- General conditions regarding export
33- Procedure at customs port
34- Export of medical devices for personal use
35- Documents to accompany the consignments of medical devices for
export
36- Suspension or cancellation of export-permit
37- No right to claim title on fraudulent enlistment, registration, license,
permit, etc
Medical Devices Rules
2017
22 February 2020

14. CHAPTER VI
LABELLING OF MEDICAL
DEVICES14
38- General provisions of labelling of medical devices
39- Location of labelling of medical devices
40- Format of labelling of medical devices
41- Language used for labelling of medical devices
42- General contents of labelling of medical devices
43- Specific contents of labelling of medical devices
44- Instructions for use on label of medical devices
45- Additional information on the label of in-vitro diagnostic medical
devices
Medical Devices Rules
2017
22 February 2020

15. CHAPTER VII
RESPONSIBILITIES AND
OBLIGATIONS15
46- General responsibilities and obligations of licensees and
enlistment or registration holders
47- Responsibilities and obligations of manufacturer
48- Responsibilities and obligations of importer or authorized
representative
49- Post-marketing surveillance and vigilance system
50- Inspector
51- Analysis by quality control laboratories
Medical Devices Rules
2017
22 February 2020

16. Chapter-VII
EXEMPTIONS, PROHIBITIONS AND
SAMPLING16
52- Exemption from operation of the rules
53- Fabrication of custom-made medical devices
54- Sampling of medical device for testing
Medical Devices Rules
2017
22 February 2020

17. Chapter-IX
USAGE, OPERATION,
MAINTENANCE, ETC.17
55- Usage, operation, maintenance, etc of medical device
56- Practitioner to keep record of implants
57- Qualification and competency of a person using or operating a
medical device
58- Qualification and competency of a person installing, testing or
maintaining a medical device.
Medical Devices Rules
2017
22 February 2020

18. Chapter-X
MEDICAL DEVICE BOARD (MDB)18
59- Medical Device Board
Medical Devices Rules
2017
22 February 2020

19. Chapter-IX APPEAL
19
60- Appeal against decision of the MDB
61- Analysis by appellate laboratory
Medical Devices Rules
2017
22 February 2020

20. Chapter-XII
MEDICAL DEVICE REGISTER20
62- Register of Medical Devices
Medical Devices Rules
2017
22 February 2020

21. Chapter-XIII FEE
21
63- Fee for various activities and amendment of Schedules
Medical Devices Rules
2017
22 February 2020

22. Chapter-XIV
ADVERTISMENT OF MEDICAL
DEVICES22
64- Medical device advertising
65- Procedure for medical device advertising
66- Conditions for advertising
Medical Devices Rules
2017
22 February 2020

23. Chapter-XV MISCELLANEOUS
22 February 2020
23
67- Outsourcing
68- Standards of testing
69- Fee to be non-refundable
70- Contravention and punishments
71- Inspection of manufacturer abroad
72- Indenting of Medical Devices
73- Technical ambiguities
74- Repeal.
Medical Devices Rules
2017

24. Medical Device GMP-20
Elements24
 Management responsibility
 Quality system controls
 Training controls
 Design/Development controls
 Document & data controls
 Purchasing controls
 Product identification & traceability
controls
 Process and manufacturing controls
 Inspection & testing controls
 Inspection, measuring, & test
equipment controls
 Process Validation
 Labels & Labeling
 Acceptance controls
 Non-conforming product controls
 Corrective & preventive action
controls
 Handling, storage, packaging,
preservation & delivery controls
 Quality record controls
 Installation & Servicing controls
 Complaint Handling controls
 Statistical technique controls
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Medical Devices Rules
2017

25. Forms
25
 FORM-1
Application form for grant or renewal of an establishment license to
manufacture medical devices
 FORM-2
Application form for grant or renewal of an establishment license to import
medical devices
 FORM-3
License to manufacture medical devices
 FORM-4
License to import medical devices
 FORM-5
Warranty under Medical Devices Rules, 2017
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Medical Devices Rules
2017

26. Forms
26
 FORM-6
Application form for enlistment or renewal of class-A medical device or
accessory or component for local manufacture.
 FORM-6A
Application form for enlistment or renewal of class–A medical device or
accessory or component for import.
 FORM-7
Application form for registration or renewal of class B, C & D medical
device or accessory or component for local manufacture
 FORM-7A
Application form for registration or renewal of class B, C & D medical
device or accessory or component for import.
22 February 2020
Medical Devices Rules
2017

27. Forms
27
 FORM-8
Certificate of enlistment or registration of a medical device or accessory or
component for local manufacture
 FORM-8A
Certificate of enlistment or registration of a medical device or accessory or
component for import
 FORM 9
Application for permit to import medical device(s) or accessories or
component(s) or raw material for the purpose of clinical investigation,
examination, test or analysis
 FORM 10
Permit to import medical devices or accessories or components or raw
material for clinical investigation, examination, test or analysis
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Medical Devices Rules
2017

28. Forms
28
 FORM 11
Intimation of arrival of consignments of imported medical devices or
accessories or components or raw material, other than those imported for
personal use.
 FORM 12
Application form for export permit of medical device or accessory or
component
 FORM 13
Export permit for medical device or accessories or components
 FORM 14
Application for export of small quantities of medical devices or accessories
or components for the purpose of clinical investigations, examination, test
or analysis
22 February 2020
Medical Devices Rules
2017

29. Forms
29
 FORM 15
Export permit for small quantities of medical devices or accessories or
components for the purpose of clinical investigations, examination, test or
analysis
 FORM-16
Medical device register
 FORM-17
Application for approval of advertisement of a medical device
 FORM-18
Permission to advertise a medical device or accessory or component
 FORM-20
Provisional establishment certificate to import medical devices provided in
schedule ―DII
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Medical Devices Rules
2017

30. Forms
30
 FORM-21
Application form for provisional registration of a medical device for import
provided in schedule d
 FORM-22
provisional certificate of enlistment or registration of a medical device or
accessory
22 February 2020
Medical Devices Rules
2017