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Medical Device establishment licensing

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MUHAMMAD SOHAIL
MUHAMMAD SOHAIL

Steps taken before application for Establishment License Under Medical Devices Rules 2015 in Pakistan

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Yes Yes Manufacturer No Authorized Representative, Importer, Distributor Figure shows the steps to be taken by an applicant before making an application to register an establishment Under Medical Devices Rules 2015 in Pakistan. Does your establishment deal with medical device? What is your establishment type? Conduct conformity Assessment on Quality management system based on GDPMD Conduct conformity Assessment on Quality Management system based on ISO 13485 Comply with all requirements and certified by CAB? Apply for establishment License Appoint a CAB to conduct conformity assessment quality management system

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Medical Device establishment licensing

  • 1. Yes Yes Manufacturer No Authorized Representative, Importer, Distributor Figure shows the steps to be taken by an applicant before making an application to register an establishment Under Medical Devices Rules 2015 in Pakistan. Does your establishment deal with medical device? What is your establishment type? Conduct conformity Assessment on Quality management system based on GDPMD Conduct conformity Assessment on Quality Management system based on ISO 13485 Comply with all requirements and certified by CAB? Apply for establishment License Appoint a CAB to conduct conformity assessment quality management system