Checklist for Medical Device Registration in Russia

1. Typical Checklist
of documents required for registration of a medical device in Russia.
FromtheManufacturer
1. The Power of Attorney on behalf of legal manufacturer in the name of a Russian Authorized
Representative.
Apostil
□
2.Establishment license (“Business license”, extract from chamber of commerce or FDA database) Apostil
□
3. ISO 13485 (or ISO 9001) certificate. Apostil
□
4. EC Certificate, including design examination certificate for class III (EU) products. Apostil
□
5. European Declaration of conformity. Apostil
□
6. Statement from Manufacturer to demonstrate relation with its facilities and sub-contractors. Apostil
□
7. Documents listed in #2-3 should be provided for every manufacturing site. Apostil
□
8. Instruction for use. □
9. Technical File
(TF): could be
provided as one or
several documents.
! Make sure that TF contains all essential elements: □
9.1 Device description and specification including complete list of models,
variants and accessories including software (if applicable).
□
9.2 Principles of operation, description of the MD all models, variants and
accessories, product construction drawing(s), indicating each product
component and accessory.
□
9.3 Statement of intended use and indications for use, contraindications, side
effects and adverse reactions.
□
9.4 Safety class and GMDN classification. □
9.5 Biocompatibility: list of all materials in direct or indirect contact with
patient or user.
□
9.6 Information on medicinal substances (if applicable) identification of its
source, intended reason for presence, safety and performance profile.
□
9.7 Labeling. □
9.8 General review of design and manufacturing information (flow chart). □
9.9 Risk analysis and control summary. □
9.10 Statement on shelf-life or/and exploitation period, transport and storage
conditions.
□
9.11List of applicable standards. □
9.12 Information on destruction and utilization. □
9.13 Clinical evidence (Clinical Evaluation Report). □
9.14 Information on sterility, sterilization (if applicable). □
9.15 Methods of cleaning/disinfection (if applicable). □
9.16 Software verification and validation (if applicable). □
9.17 Warranty statements (if applicable). □
10. High resolution photo(s) 18x24 cm representing of all models, variants and accessories. □
FromRussian
AR
11. Report on technical (and EMC) testing performed in Russia. □
12. Report on biocompatibility testing performed in Russia. □
13. Administrative documents from Russian Authorized representative. □
14. Fees payment confirmation. □
November 2015
www.MedicalDevicesInRussia.com
Alexey@MedicalDevicesInRussia.com