Slide explains the principles of product grouping for submission for registration of medical device in RosZdravNadzor (Russia).

1. How Can You Group Medical Devices for Registration in Russia?
MEDICAL DEVICE:
DEVICE AAA, modifications:
-DEVICE AAA-01.
-DEVICE AAA-02.
-DEVICE AAA-03.
-DEVICE AAA -05.
ACCESSORIES:
1.Accessory AAB (5 items).
2. Accessory AAC (10 items).
3. Accessory AAZ (not more than 20 items).
Slide is prepared by Alexey Stepanov for Russian Medical
Device RA group based on clarifications done by Head of
MD registration department Ms Elena Astapenko on
FarmMedObrashenie conference, May 2014
The name of the device :
must contain information that allows it to
be identified unambiguously (clear model,
type, article, etc.)
Accessories:
– Accessories are items that are not
medical devices but are intended to
provide its proper function.
– If an ‘accessory’ is intended to be
used without the ‘main’ medical device,
it must be registered separately.
– The exact number of accessories to
be supplied with one ‘main’ medical
device must be clearly listed.
– Accessories and the ‘main’ device
can be of different classes (e.g.
sterile/non-sterile; single use/non-
single use; active/non-active).
Several models/modifications of one
medical device can be grouped in
one submission if:
-They have the same intended use.
-They have the same class according
to MoH order 4-N (e.g. sterile/non-
sterile; single use/non-single use;
active/non-active).
-They have the same safety class.
-They have the same technical
characteristics and principles of
operation.
-They are manufactured by the same
manufacturer.
-The ‘head’ model fully reflects the
technical parameters of the whole
model range.