Requirements of Roszdravnadzor for photos of a medical device for registration dossier.

1. • Provide real photo (no drawings acceptable) in high
resolution, sized at least 18x24cm.
• Provide one or several photo(s) with general view of a
medical device with all accessories (listed in
submission registration form).
• Identify every item on the photo:
-by means of references using graphic editor program.
or
-by means of legible labeling on photo.
• If you register a range of same medical devices with
different sizes, it is allowed to provide one photo
(photos of all sizes are not required).
• If you register in one dossier different medical
devices, it is acceptable to provide one photo of each
type additionally providing product catalogue.
Medical device AAA
Accessory AAA-01
Accessory AAA-02
Accessory AAA-03
>18cm
>24cm
How to provide proper photos for medical device
registration dossier?
Slide prepared by Alexey Stepanov for Russian Medical Device RA group. August 2014 . www.medicaldevicesinrussia.com