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Medical Device establishment licensing
The document outlines the steps for an applicant to register an establishment under the medical devices rules of 2015 in Pakistan. It includes determining the establishment's involvement with medical devices, conducting conformity assessments based on relevant quality management standards, and applying for an establishment license. It emphasizes the need for compliance with requirements and certification by a competent authority.
Medical Device establishment licensing
- 1. Yes Yes Manufacturer No Authorized Representative, Importer, Distributor Figureshows 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