Pakistan Medical Devices Regulations

Pakistan Medical Devices Regulations

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  Medical Devices Rules,2017 Rashid Mureed
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  Pakistan Medical DevicesRules, 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
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  Medical Device 3 Defines amedical 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 22 February 2020 Medical Devices Rules 2017
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  Classification “Terms” 4  Classified Un-classified  Not Classified 22 February 2020 Medical Devices Rules 2017
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  Device Classification 5  1700generic 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 22 February 2020 Medical Devices Rules 2017
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  Classification System-Risk Categorization 6  ClassI 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) 22 February 2020 Medical Devices Rules 2017
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  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 22 February 2020 Medical Devices Rules 2017
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  Chapter-I 8 1. Short Titleand Commencement 2. Definition 22 February 2020 Medical Devices Rules 2017
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  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 22 February 2020 Medical Devices Rules 2017
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  Chapter II- Classification AndGrouping Of Medical Devices10 11- Classification and grouping of medical devices Medical Devices Rules 2017 22 February 2020
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  CHAPTER IV ENLISTMENT ANDREGISTRATION 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
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  CHAPTER V IMPORT ANDEXPORT12 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
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  CHAPTER V IMPORT ANDEXPORT13 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
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  CHAPTER VI LABELLING OFMEDICAL 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
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  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
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  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
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  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
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  Chapter-X MEDICAL DEVICE BOARD(MDB)18 59- Medical Device Board Medical Devices Rules 2017 22 February 2020
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  Chapter-IX APPEAL 19 60- Appealagainst decision of the MDB 61- Analysis by appellate laboratory Medical Devices Rules 2017 22 February 2020
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  Chapter-XII MEDICAL DEVICE REGISTER20 62-Register of Medical Devices Medical Devices Rules 2017 22 February 2020
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  Chapter-XIII FEE 21 63- Feefor various activities and amendment of Schedules Medical Devices Rules 2017 22 February 2020
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  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
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  Chapter-XV MISCELLANEOUS 22 February2020 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
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  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 22 February 2020 Medical Devices Rules 2017
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  Forms 25  FORM-1 Application formfor 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 22 February 2020 Medical Devices Rules 2017
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  Forms 26  FORM-6 Application formfor 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
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  Forms 27  FORM-8 Certificate ofenlistment 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 22 February 2020 Medical Devices Rules 2017
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  Forms 28  FORM 11 Intimationof 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
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  Forms 29  FORM 15 Exportpermit 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 22 February 2020 Medical Devices Rules 2017
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  Forms 30  FORM-21 Application formfor 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