Medical Device Registration in Russia

By cmsmedtech July 26, 2020

Table of Contents

Medical Device Registration in Russia

Please click here to access to Russia authority website.

Please see below for the requirements.

No	Document	Method of authorization
1	Business registration	Legalization (embassy authorization or apostille)
2	Power of Attorney (please, see a template)	Legalization (embassy authorization or apostille)
3	Addendum to PoA (please, see a template)	Legalization (embassy authorization or apostille)
4	EC MDD certificate	Legalization (embassy authorization or apostille)
5	CE DOC	Legalization (embassy authorization or apostille)
6	ISO 13485 for all production sites	Legalization (embassy authorization or apostille)
7	Trademark registration documents	A link to an open database
8	Technical documentation (Technical Document, Technical File, Specification)	No authorization is required
9	Operational documentation (User manual, instruction for use)	No authorization is required
10	Risk Management File	Company authorization and notary authorization for test reports
11	Clinical Evaluation Report	Company authorization and notary authorization for test reports
12	Published articles about medical device (at least 3)	No authorization is required
13	Good-quality colour pictures 18х24 (without package, with its package and all the accessories)	No authorization is required
14	Labels picture	No authorization is required
15	Shelf life, number of uses (and test reports proving this information)	Company authorization and notary authorization for test reports
16	Sterilization validation	Company authorization and notary authorization for test reports
17	A list of test reports you have provided for CE MDD certification	No authorization is required
18	Production flow chart	No authorization is required
19	Label drafts (if any)	No authorization is required
20	MSDS for the device and packaging	Company authorization and notary authorization for test reports
21	Drawings	No authorization is required