Questionnaire required for calculating the cost of work and consulting for registration on

the territory of the Russian Federation for national registration under regulation 1416

No. Question Items

1. Potential risk class of the Medical 1
device: 2a non-sterile
2a sterile
2b
3
* - I , II , III (for products complying with EU Directives
93/42 or ivd 98/79)
- a, b , c , d (for products complying with EU Directives
2017-745 or ivd 2017/746)
2. Is there an Authorized Representative of
the manufacturer in the Russian
Federation?
Manufacturer information
3. Country of Origin domestic
foreign
4. Number of production sites * in case of several production sites:
- multi-stage production (at several sites there are
different stages of production)
or
- each site carries out a full cycle production process
5. Does the manufacturer have a valid ISO Not
13485 certificate: really
* for a legal manufacturer;
* to all production sites.
6. Are the products distributed in the USA? * indicate which document is available
If you apply, ask about the availability of
documents:
-Certificate for Foreign Government
(CFG);
-Extract from FDA;
-Resolution 510k.
7. Are the products traded in the EU? * indicate which document is available
If you apply, ask about the availability of
documents:
- EU Declaration of Conformity
Standard 2017-745 or 93/42 (in the case
of ivd 2017/746 or 98/79);
- EU Certificate of Conformity with the
requirements of Standard 2017-745 or
93/42 (in the case of ivd 2017/746 or
98/79)
- (+EC DesignExamination Certificate
only For MI 3rd class risk )
8. Does the manufacturer have a valid Not
certificate giving the right to sell medical really
devices in the country of production?
Product Information
9. Name of the medical device from the
manufacturer
10. Number of variants/models of medical
device
11. Does the medical device have
accessories? Their number?
12. Type of contact of the medical device
with the patient's body?
13. How does the product contact the Contacts the surface of the human body
human body?
14. What is the duration of contact of the Short-term contact products - less than 24 hours.
product with the human body? (Category A)

15. Are there any registered analogues of Yes (provide RU number or product name)
this medical device in the Russian No, there are no registered analogues, but there are
Federation? analogues abroad and there are documents confirming
the effectiveness and safety of the product
No, the technology is innovative and there are no
analogues registered in Russia or abroad
16. the medical product contain a drug? No

17. Does the product contain sterile Yes, supplied sterile

components? Yes, sterilized before use
*if yes, please provide the sterilization No
method
18. Is the product electrical? No
19. Does it come with pre-installed Not really
software?
20. Is the technical and operational Yes, everything is in stock and ready
documentation ready in accordance with
the legislation of the Russian Federation
for testing?