2.1 General Administration Of Factories Licenses:
About The administration:
It is one of the Central Administration of Operations which Issuing factories licenses.
2.1.1 The administration of Medical devices and Kits Factories Licensing
About The administration:
*The administration of Medical devices and kits Factories Licensing is an administration affiliated with the General Administration of Factories Licensing - the Central Administration of Operations.
*The Medical devices and kits Factories Licensing Administration, in cooperation with the General Authority for Industrial Development (IDA), licenses all types of medical devices and kits factories ( sterile medical devices factories - non-sterile medical devices factories - ready to be sterilized - prosthetics, orthotic devices, and mobility aids factories - Factories that produce medical devices in dosage forms - Factories that produce in-vitro diagnostics) and issue a technical license for operation after conducting the licensing inspections to ensure the implementation of Good Manufacturing GMP requirements, in regards to the implementation of the law establishing the Egyptian drug Authority No. 151 of 2019 and Law No. 15 of 2017 to facilitate licensing procedures.
Responsibilities:
*Ensure the application of Good Manufacturing GMP requirements for licensing factories, adding a new production line to a factory, or approving any amendment to the factory, such as amending the engineering drawing, adding a machine, replacing a machine, or canceling a production line.
*Ensure the implementation of good storage requirements (GSP) for adding a store within the factory boundaries or adding an accessory store to a licensed factory.
*Issuing a technical license for operation for medical devices and kits factories
*Issuing a license for a accessory store to a licensed factory.
*Amending the technical license for operation to amend the data related to the technical license for operation, including changing the name of the factory, addition/cancelling a plot of land for the factory, changing the name of the factory, transferring the ownership of the factory, or changing the factory managers.
*issuing typical copies of the technical license for operation.
Factories licensing in cooperation with the General Authority for Industrial Development:
1-The factory submits a completed license file to the Industrial Development Authority with the payment receipt of 5 L.E.
2- The Industrial Development Authority sends the application and documents to the General Administration of Factory Licensing to determine the inspection date, after applying the required requirements appropriate to the factory’s activity (the guideline for the requirements for licensing factories of medical devices and in vitro diagnostics /the guideline for the technical requirements for licensing and operating factories of prosthetics, orthotic devices, and mobility aids factories) and these requirements are published on the official website of the Egyptian drug Authority.
3-A joint inspection committee is conducted by the industrial development authority and the Egyptian drug Authority through a committee formed in accordance with the decision of the Chairman of the Egyptian Medicine Authority No. 119 of 2022 to ensure the implementation of good manufacturing requirements.
4- After carrying out the necessary inspections to ensure the implementation of Good Manufacturing GMP requirements and fulfillment of the notes, the factory completes the required documents on the Google Drive link of the General Administration of Factory Licensing to extract the technical operating license and the technical operating license is issued.
Link google drive
The factory enters the electronic window of the General Administration of Factory Licensing
Fill out the form according to the required service
*NB: -
The Minister of Commerce and Industry Resolution No. 493 of 2023 was issued, Article 1 of which “Establishments that have an operating license for activities (manufacturing prosthetic limbs - prosthetic devices - mobility aids) shall be granted a five-year reconciliation grace period, and for activities (manufacturing medical devices and devices - diagnostic reagents) a reconciliation grace period.” Conditions for a period of one year, with the deadlines for adjusting conditions starting from 1/1/2024
-:Location of Central Administration Of Operation
51stWezaretElzeraa,Agouza,Giza
https://maps.app.goo.gl/R9quBaDbqiWaGCMn7
Tel: 0223684288