Section code

Document type code

Name of document type

01

Applications

0101

application for registration of a medical device

0102

application for expert examination of a medical device

0103

application for issuance of a duplicate of a registration certificate for a medical device

0104

application for amendments to the registration dossier of a medical device

0105

application for cancellation (revocation) of the registration certificate for a medical device

0106

application for amendments to the registration dossier of a medical device in a notification procedure

0107

application for approval of the expert opinion on the registered medical device

(ed. by Decision of the Board of the Eurasian Economic Commission from 15.08.2023 N 110)

02

Powers of attorney and contracts

0201

Power of attorney from the manufacturer for the right to represent interests during registration

0202

power of attorney from the manufacturer or authorized representative of the manufacturer for the right to represent interests during the procedure of approval of the expert opinion on the registered medical device

0203

contract between the manufacturer and the manufacturer's authorized representative

(in edition of the decision of the Board of the Eurasian Economic Commission from 15.08.2023 N 110)

03

declarations

0301

declaration of conformity of a medical device to the mandatory requirements of states that are not members of the Eurasian Economic Union

0302

document equivalent to the declaration of conformity of a medical device to the mandatory requirements of states that are not members of the Eurasian Economic Union

(ed. Decision of the Board of the Eurasian Economic Commission from 15.08.2023 N 110)

04

Certificates of conformity of quality management system

0401

certificate of conformity of the quality management system of medical devices manufacturer to the requirements of ISO 13485 standard

0402

certificate of conformity of the quality management system of the manufacturer of medical devices to the requirements of the regional standard of the Eurasian Economic Union member state

0403

certificate of conformity of the quality management system of the manufacturer of medical devices to the requirements of the national standard of the Eurasian Economic Union member state

0404

certificate of conformity of the quality management system of the production site to the requirements of ISO 13485 standard

0405

Certificate of compliance of the quality management system of the production site with the requirements of the regional standard of the Eurasian Economic Union member state

0406

certificate of compliance of the quality management system of production site with the requirements of the national standard of a member state of the Eurasian Economic Union.

(in edition of the decision of the Board of the Eurasian Economic Commission from 15.08.2023 N 110)

05

Permit documents (licenses)

0501

Authorization document confirming the right of production in the country of the producer

06

Document confirming registration of the medical device in third countries

0601

document confirming the registration of a medical device in third countries

0602

information on registration in other countries with reference to the current sources of such information

(ed. Decision of the Board of the Eurasian Economic Commission from 15.08.2023 N 110)

07

Registration certificates, export certificates, free sale certificates

0701

free sale certificate issued in the country of manufacturer

0702

export certificate issued in the country of manufacture

0703

certificate of free sale issued in the country of producer (Russian translation)

0704

export certificate issued in the country of manufacture (Russian translation)

0705

registration certificate of medical device issued in the country of manufacturer

0706

registration certificate of a medical device issued in accordance with the law of the Eurasian Economic Union

0707

duplicate of the registration certificate of a medical device issued in accordance with the law of the Eurasian Economic Union

(ed. Decision of the Board of the Eurasian Economic Commission from 15.08.2023 N 110)

08

Description of medical device

0801

deleted. - Decision of the Board of the Eurasian Economic Commission from 15.08.2023 N 110

0802

photographic image of the general view of the medical device and its accessories (if any)

(ed. Decision of the Board of the Eurasian Economic Commission from 15.08.2023 N 110)

09

Layouts of packaging and labeling

0901

document containing the text of labeling in Russian language

0902

document containing the text of labeling in the state language of a member state of the Eurasian Economic Union

0903

medical device packaging layout

0904

medical product label layout

0905

medical device sticker layout

0906

document containing labeling and packaging data approved during the registration of the medical device, taking into account the changes made in the registration dossier of the medical device

0907

document containing the text of labeling in the state language(s) of the state(s) of recognition specified in the application for approval of the expert opinion for the registered medical device

(ed. by Decision of the Board of the Eurasian Economic Commission from 15.08.2023 N 110)

10

Instructions, operating manuals

1001

Operating document for the medical device in Russian language

1002

Operating document for a medical device in the state language of a member state of the Eurasian Economic Union

1003

instruction for use of the medical device in Russian language

1004

instructions for use of a medical device in the official language of a member state of the Eurasian Economic Union 1004

1005

service manual for the medical device in Russian language

1006

service manual for a medical device in the official language of a member state of the Eurasian Economic Union 1006

1007

operating document approved during registration of the medical device, taking into account the changes made in the registration dossier of the medical device, in the state language(s) of the state(s) of recognition specified in the application for approval of the expert opinion on the registered medical device

1008

instructions for use of the medical device approved at the time of registration of the medical device, taking into account the amendments made to the registration dossier of the medical device, in the official language(s) of the State(s) of recognition indicated in the application for approval of the expert opinion on the registered medical device

1009

service manual approved at the time of registration of the medical device, taking into account the changes made in the registration dossier of the medical device, in the official language(s) of the State(s) of recognition indicated in the application for approval of the expert opinion on the registered medical device

(ed. Decision of the Board of the Eurasian Economic Commission from 15.08.2023 N 110)

11

Reviews

1101

a brief overview of adverse events and/or accidents related to the use of the medical device

12

Reports

1201

report on the results of the initial inspection of the manufacture of a medical device

1202

report on risk analysis and management

1203

report on clinical evidence of efficacy and safety of a medical device

1204

report on stability studies with authentic translation into Russian of test results (for products with shelf life)

1205

report on clinical trial (research) of a medical device

1206

report on clinical and laboratory testing (research) of a medical device for in vitro diagnostics

1207

reports on the results of periodic (scheduled) production inspection

1208

reports on the results of unscheduled production inspection

1209

report on assessment of biological effect of a medical device

(ed. Decision of the Board of the Eurasian Economic Commission from 15.08.2023 N 110)

13

Lists

1301

list of standards applied by the manufacturer in the design and manufacture of the medical device

1302

list of adverse events and (or) accidents related to the use of the medical device

1303

list of withdrawals of medical devices from the market and (or) explanatory notifications

(ed. Decision of the Board of the Eurasian Economic Commission from 15.08.2023 N 110)

14

Plans

1401

plan for collection and analysis of data on safety and efficacy of medical devices at the post-marketing stage

15

Protocols and programs of tests (studies) to assess the safety of the product

1501

protocol of technical tests of a medical device conducted for the purpose of proving its compliance with general safety and efficacy requirements medical devices, requirements to their labeling and operational documentation for them

1502

protocol of studies (tests) for evaluation of biological effect of a medical device conducted for the purpose of proving its compliance with general requirements of safety and effectiveness of medical devices, requirements to their labeling and operational documentation for them 1502

1503

document confirming the results of tests of medical devices for the purpose of type approval of measuring instruments

1504

program of technical tests of a medical device conducted for the purpose of proving its compliance with general requirements of safety and efficiency of medical devices, requirements to their labeling and operational documentation for them 1504

1505

documents containing the first party evidence (as regards technical tests of a medical device)

1506

program of researches (tests) on assessment of biological effect of a medical device, conducted in order to prove its compliance with general requirements of safety and effectiveness of medical devices, requirements to their labeling and operational documentation for them

(ed. Decision of the Board of the Eurasian Economic Commission from 15.08.2023 N 110)

16

Documents and information on changes made to the registration dossier of a medical device

1601

deleted. - Decision of the Board of the Eurasian Economic Commission from 15.08.2023 N 110

1602

deleted. - Decision of the Board of the Eurasian Economic Commission from 15.08.2023 N 110

1603

deleted. - Decision of the Board of the Eurasian Economic Commission from 15.08.2023 N 110

1604

deleted. - Decision of the Board of the Eurasian Economic Commission from 15.08.2023 N 110

1605

deleted. - Decision of the Board of the Eurasian Economic Commission from 15.08.2023 N 110

1606

documents and information on changes made to the registration dossier of a medical device

1607

documents confirming the changes and certifying that the introduction of these changes does not entail changes in the properties and characteristics of the medical product affecting its safety, quality and effectiveness, or improves its properties and characteristics with unchanged functional purpose and (or) principle of operation of the medical product.

(ed. Decision of the Board of the Eurasian Economic Commission from 15.08.2023 N 110)

17

Other documents and information

1701

document on compliance of a medical device with the general requirements for safety and effectiveness of medical devices, requirements to their labeling and operational documentation for them

1702

document confirming biological safety of the medical device

1703

information on special software, including manufacturer's information on software validation

1704

document containing information on medicinal products in a medical device

1705

document containing information on the development and manufacture of the medical device, including a description of the manufacturing process flowchart, the main stages of production, packaging, testing and the procedure for the release of the final product

1706

document containing information on the manufacturer

1707

document containing information on marketing

1708

a description of the approach to handling adverse events and/or accidents related to the use of the medical device and the actions taken by the manufacturer in response to those events and/or accidents

1708

description of the analysis and/or corrective actions taken with respect to adverse events and (or) accidents related to the use of the medical product

1709

document establishing requirements for the technical characteristics of the medical device

1710

information on the sterilization procedure, including information on validation of the sterilization process, results of testing of the medical device for microbial content (degree of biological load), pyrogenicity, sterility (if necessary) (with indication of test methods and information on validation of packaging)

1711

documents referenced in the information on compliance of the medical device with the general requirements for safety and effectiveness of medical devices, requirements for their labeling and operational documentation for them

1712

documents confirming the quality of a medicinal product, biological material and other substances that are part of a medical device and come into contact with the human body in accordance with the intended use of the medical device and are intended for use only for the intended use of the medical device as defined by the manufacturer, and issued in accordance with the legislation of the country of origin of the medicinal product, biological material and other substances

1713

document of the manufacturer confirming his intention to cancel the validity of the registration certificate of the medical device (revoke it)

1714

inventory

1799

other

(ed. Decision of the Board of the Eurasian Economic Commission from 15.08.2023 N 110)

18

Documents on registration of legal entities or individuals registered as individual entrepreneurs

1801

document confirming the registration of the manufacturer's authorized representative as a legal entity or individual entrepreneur

1802

document or information confirming registration of the producer as a legal entity or individual entrepreneur 1802

(introduced by Decision of the Board of the Eurasian Economic Commission from 15.08.2023 N 110)

19

Documents confirming payment

1901

Documents confirming payment for registration and examination procedures in the reference state

1902

documents confirming payment for the procedure of amendments to the registration dossier of the medical device in the reference state and the procedure of approval of the expert opinion in the state(s) of recognition, as well as issuance of the registration certificate of the medical device in the reference state

1903

documents confirming payment for the procedure of amendment of the registration dossier of the medical device in a notification procedure in the reference State, as well as issuance of the registration certificate of the medical device in the reference State

1904

documents confirming payment for the issuance of a new registration certificate for the medical device in the reference state

1905

documents on payment for the procedure of approval of the expert opinion in the State(s) of recognition indicated in the application for approval of the expert opinion for the medical device

(introduced by Decision of the Board of the Eurasian Economic Commission from 15.08.2023 N 110)

N item

Element designation

Description

1

2

3

1

Code

0__

2

Type

2 - classifier

3

Name

classifier of types of documents of the medical device registration dossier

4

Abbreviation

KVDRDMI

5

Designation

ЕК 048 - 2023 (ed. 2)

(in edition of the decision of the Board of the Eurasian Economic Commission from 15.08.2023 N 110)

6

Details of the act on the adoption (approval) of the directory (classifier)

Decision of the Board of the Eurasian Economic Commission of April 3, 2018 N 48

7

Date of enactment (beginning of application) of the directory (classifier)

20__ г.

8

Details of the act on termination of the reference book (classifier) application

-

9

Date of termination of reference (classifier) application

-

10

Operator(s)

RU, Federal Service for Supervision in the Sphere of Healthcare

11

Purpose

is intended for presentation of information on types of documents of the registration dossier of a medical device

12

Abstract (scope of application)

is used when performing procedures related to the registration of medical devices, including to ensure information interaction in the implementation of common processes within the Eurasian Economic Union

13

Keywords

registration dossier document, medical device registration

14

Sphere in which the powers of the Eurasian Economic Union bodies are realized

technical regulation

15

Use of international (interstate, regional) classification

2 - international (interstate, regional) classifiers and (or) standards were not used in the development of the classifier

16

Presence of state directories (classifiers) of the Eurasian Economic Union member states

2 - the classifier has no analogs in the member states of the Eurasian Economic Union

17

Method of systematization (classification)

2 - hierarchical, the number of steps (levels) - 2

18

Method of maintenance

1 - centralized maintenance procedure. Adding, changing or excluding classifier values is performed by the operator in accordance with the act of the Eurasian Economic Commission. In case of exclusion of a value, the classifier record is marked as inactive from the date of exclusion with the indication of the act of the Eurasian Economic Commission regulating the expiration of the classifier record. Codes of classifier records are unique, reuse of codes of classifier records, including invalid ones, is not allowed.

19

Structure

information on the structure of the classifier (composition of the classifier fields, areas of their values and rules of formation) is specified in section III of this classifier.

20

Degree of data confidentiality

information from the classifier belongs to the information of open access

21

Established periodicity of revision

not established

22

Changes

-

23

Reference to detailed information from the directory (classifier)

detailed information from the classifier is specified in section I of this classifier

24

Method of presentation of information from the directory (classifier)

publication on the information portal of the Eurasian Economic Union

Name of requisite

Value area of the requisite

Rules for forming the value of the requisite

Mn.

1. Information on the types of documents of the medical device registration dossier

is determined by the value areas of the nested requisites

is determined by the rules of formation of nested requisites

1..*

1.1 Code of the section of the classifier of types of documents of the medical product registration dossier

normalized character string.

Template: \d{2}

the code designation is formed using the sequential coding method

1

1.2 Name of the section of the classifier of types of documents of the medical device registration dossier

character string.

Min. length: 1.

Max. length: 4000

is formed as a word combination in Russian language

1

1.3 Information about the type of document of the medical device registration dossier

is determined by the value areas of nested requisites

is determined by the rules of nested requisites formation

1..*

1.3.1 Code of the type of document of the medical device registration dossier

normalized character string.

Template: \d{4}

the code designation is formed using the sequential coding method

1

1.3.2 Name of the type of document of the medical device registration dossier

character string.

Min. length: 1.

Max. length: 4000

is formed as a word combination in Russian language

1

1.3.3 Information about the directory (classifier) record

determined by the value areas of nested requisites

is determined by the rules of nested requisites formation

1

*.1 Start date

date designation in accordance with GOST ISO 8601-2001 in the format YYYY-MM-DD

corresponds to the date of the beginning of the action specified in the act of the Eurasian Economic Union body

1

*.2 Information about the act regulating the beginning of validity of the directory (classifier) record

is determined by the areas of values of nested requisites

is determined by the rules of formation of nested requisites

1

*.2.1 Type of act

normalized character string.

Template: \d{5}

code designation of the act in accordance with the classifier of types of normative legal acts of international law

1

*.2.2 Act number

character string.

Min. length: 1.

Max. length: 50

corresponds to the act number of the Eurasian Economic Union body

1

*.2.3 Date of the act

date designation in accordance with GOST ISO 8601-2001 in the format YYYYY-MM-DD

corresponds to the date of adoption of the act of the Eurasian Economic Union authority

1

*.3 Date of expiration

date designation in accordance with GOST ISO 8601-2001 in the format YYYYY-MM-DD

corresponds to the expiration date specified in the act of the Eurasian Economic Union authority

0..1

*.4 Information about the act regulating the expiration date of the directory (classifier) record

is determined by the areas of values of nested requisites

is determined by the rules of nested requisites formation

0..1

*.4.1 Type of act

normalized character string.

Template: \d{5}

code designation of the act in accordance with the classifier of types of normative legal acts of international law

1

*.4.2 Act number

character string.

Min. length: 1.

Max. length: 50

corresponds to the act number of the Eurasian Economic Union body

1

*.4.3 Date of the act

date designation in accordance with GOST ISO 8601-2001 in the format YYYYY-MM-DD

corresponds to the date of adoption of the act of the Eurasian Economic Union authority

1