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Medical Devices Rules 2017 Pakistan - Amendments 2022

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MUHAMMAD SOHAIL
MUHAMMAD SOHAIL

Medical Devices Rules 2017 of Pakistan have been amended in 2022.

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MEDICAL DEVICES RULES,2017 – Pakistan (AMENDMENTS) S.R.O. 559(I)/2022 Prepared By: Muhammad Sohail (PharmD) Member APACMed Member GHWP
Contents  ADDITIONS  OMISSIONS  SUBSTITUTIONS
Additions Following additions have been made in Medical Devices Rules, 2017  Any establishment which perform the functions of refurbishment has been defined as manufacturer.  The term refurbished medical device has been defined now.  Procedure for import of medical devices for donation has been defined now.  No objection certificate for export will now also be issued to those licensed manufacture who have applied for registration of medical devices.
Additions Following additions have been made in Medical Devices Rules, 2017  Medical Devices having CE mark issued by conformity assessment bodies (CABs) notified in NANDO database shall be exempted from inspection of manufacturer abroad.  Commercial indenting is allowed now.  Medical devices including those the export of which is otherwise prohibited without enlistment or registration can be exported for donation after obtaining NOC.  MDB has been authorized to issue Emergency Use Authorization.
Additions Following additions have been made in Medical Devices Rules, 2017  Refurbished medical devices shall be regulated as per procedure.  New Form-1(A) for outsourcing of manufacturing process request has been introduced  New Form-1(B) for outsourcing of analysis process request has been introduced  New Form-3(A) for outsourcing of manufacturing process permission has been introduced  New Form-3(B) for outsourcing of analysis process permission has been introduced
Additions Following additions have been made in Medical Devices Rules, 2017  New Schedule F that provides information for the followings has been introduced  The Contractor  Contract Acceptor  Contract Giver  Procedure for grant of outsourcing permission  Conditions for issuance of certificate  Extent of Outsourcing  General responsibilities and Obligations
Omissions Followings have been omitted from Medical Devices Rules, 2017  General conditions for import  Export permit for medical devices  Authorization for sole representative
Substitutions Followings have been substituted in Medical Devices Rules, 2017  Export permit requirement has been substituted with No objection certificate for export  Sole representative requirement has been substituted with representatives  Commercial indenting is allowed

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Medical Devices Rules 2017 Pakistan - Amendments 2022

  • 1. MEDICAL DEVICES RULES,2017 – Pakistan (AMENDMENTS) S.R.O. 559(I)/2022 Prepared By: Muhammad Sohail (PharmD) Member APACMed Member GHWP
  • 3. Additions Following additions have been made in Medical Devices Rules, 2017  Any establishment which perform the functions of refurbishment has been defined as manufacturer.  The term refurbished medical device has been defined now.  Procedure for import of medical devices for donation has been defined now.  No objection certificate for export will now also be issued to those licensed manufacture who have applied for registration of medical devices.
  • 4. Additions Following additions have been made in Medical Devices Rules, 2017  Medical Devices having CE mark issued by conformity assessment bodies (CABs) notified in NANDO database shall be exempted from inspection of manufacturer abroad.  Commercial indenting is allowed now.  Medical devices including those the export of which is otherwise prohibited without enlistment or registration can be exported for donation after obtaining NOC.  MDB has been authorized to issue Emergency Use Authorization.
  • 5. Additions Following additions have been made in Medical Devices Rules, 2017  Refurbished medical devices shall be regulated as per procedure.  New Form-1(A) for outsourcing of manufacturing process request has been introduced  New Form-1(B) for outsourcing of analysis process request has been introduced  New Form-3(A) for outsourcing of manufacturing process permission has been introduced  New Form-3(B) for outsourcing of analysis process permission has been introduced
  • 6. Additions Following additions have been made in Medical Devices Rules, 2017  New Schedule F that provides information for the followings has been introduced  The Contractor  Contract Acceptor  Contract Giver  Procedure for grant of outsourcing permission  Conditions for issuance of certificate  Extent of Outsourcing  General responsibilities and Obligations
  • 7. Omissions Followings have been omitted from Medical Devices Rules, 2017  General conditions for import  Export permit for medical devices  Authorization for sole representative
  • 8. Substitutions Followings have been substituted in Medical Devices Rules, 2017  Export permit requirement has been substituted with No objection certificate for export  Sole representative requirement has been substituted with representatives  Commercial indenting is allowed