Specifically, you need the following documents:
1, production license renewal application form (3)
2, production license change application form (3)
3, a copy of the original production license copy (2)
4, industrial and commercial A copy of the business license (2)
5, the scope of the product to be produced and introduction (including product standards and technical description) (2)
6, the product production process flow chart (2)
7, change the instructions (2)
8, equipment list (production equipment and inspection equipment) (2)
9, such as sterile products, you need to provide a clean room test report is valid (2 copies)
10, self-assurance statement (2 copies)
Of course, there are differences in each place, the relevant form in the local Drug Administration online can be downloaded. If you have any questions, please consult me oh!
I hope this helps you! (For more information, please consult Freeda Medical Devices)