Medical Devices Establishment Licenses

Last Updated on February 23, 2022

Medical Devices manufacturers and importers are required to have an authorization from DRAP in the form of Establishment Licenses. Division of Medical Devices and Medicated Cosmetics is responsible for regulatory oversight for medical device manufactures and importers in Pakistan.

There are two types of establishment licenses of medical device

1Establishment License to manufacture medical devices, components or accessories
2Establishment License to import medical devices components or accessories
Establishment License are valid for 05 years, until, unless revoked or suspended earlier.

Application process for Medical Device Establishment License

Application forms, checklist and templates of required documentation according to each type of Establishment License is intended to assist applicants for making an application to DRAP.  Medical Devices and Cosmetics online licensing system provides an online platform to the applicants and regulators for application management of all aspects of issuance of new establishment license.