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 |
Contact us here for more information on Medical Device Registration in Russia.
