Medical Device Establishment licence process
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The document outlines the steps required for an applicant to register an establishment under Pakistan's Medical Devices Rules 2017. An applicant must first determine if their establishment deals with medical devices and what type of establishment it is - manufacturer or importer. The establishment will then need to fill out either Form 1 or Form 2 depending on if they are a manufacturer or importer. They must also comply with Good Distribution Practices for Medical Devices and pass an inspection by the Medical Devices Bureau or panel of experts to receive an establishment license.
Medical Device Establishment licence process
- 1. Yes Yes Manufacturer No Authorized Representative, Importer Figure shows the steps to be taken by an applicant to register an establishment Under Medical Devices Rules 2017 in Pakistan. Does your establishment deal with medical device? What is your establishment type? Form-2 (Importer) Compliance of GDPMD Form-1 (Manufacturing) Compliance for GMP, GSP & GDP for Comply with all requirements and satisfactory report by MDB? Establishment License on Form-3(Manufacturer) or Form-4(Importer) Inspection by MDB Or Panel of Experts