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Yes
Yes
No
Figure shows the steps to be taken by an applicant before making an application to register a
medical device Under Medical Devices Rules 2015 in Pakistan.
Is the product a
medical device?
Classify the
medical device
Group the
medical device
Conduct conformity
Assessment and collect
evidence of conformity
Appoint a CAB to
conduct conformity
assessment
Comply with all
requirements?
Apply for
registration

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Medical Device Registration in Pakistan

  • 1. Yes Yes No Figure shows the steps to be taken by an applicant before making an application to register a medical device Under Medical Devices Rules 2015 in Pakistan. Is the product a medical device? Classify the medical device Group the medical device Conduct conformity Assessment and collect evidence of conformity Appoint a CAB to conduct conformity assessment Comply with all requirements? Apply for registration