Decision of the Board of the Eurasian Economic Commission dated August 21, 2018 No. 135

(as amended on August 15, 2023)

"On the Classifier of Types of Documents Issued During the Review of the Registration Dossier of a Medical Device"



BOARD OF THE EURASIAN ECONOMIC COMMISSION


DECISION

dated August 21, 2018 N 135.


CLASSIFIER

TYPES OF DOCUMENTS TO BE PRODUCED DURING THE REVIEW

MEDICAL DEVICE REGISTRATION DOSSIER



List of amending documents

(ed. by the decision of the Board of the Eurasian Economic Commission

from 15.08.2023 N 111)



In accordance with Article 31 of the Treaty on the Eurasian Economic Union of May 29, 2014, paragraphs 4 and 7 of the Protocol on Information and Communication Technologies and Information Interaction within the Eurasian Economic Union (Annex N 3 to the Treaty) and guided by the Regulations on a unified system of regulatory and reference information of the Eurasian Economic Union, approved by Decision of the Board of the Eurasian Economic Commission of November 17, 2015 N 155, the Board of the Eurasian Economic Commission decided:
1. To approve the attached classifier of types of documents to be executed during the review of the registration dossier of a medical device (hereinafter referred to as the classifier).
2. To include the classifier in the resources of the unified system of normative and reference information of the Eurasian Economic Union.
3. Establish that:
classifier shall be applied from the date of entry into force of this Decision;
the use of code designations of the classifier is mandatory when implementing common processes within the Eurasian Economic Union in the sphere of medical devices circulation.
4. This Decision shall enter into force upon expiration of 30 calendar days from the date of its official publication.

Chairman of the Board

Eurasian Economic Commission

T. SARKISYAN






Approved

By decision of the Board

Eurasian Economic Commission

dated August 21, 2018 N 135.


CLASSIFICATOR

TYPES OF DOCUMENTS TO BE PRODUCED DURING THE REVIEW

MEDICAL DEVICE REGISTRATION DOSSIER



List of amending documents

(ed. by the decision of the Board of the Eurasian Economic Commission

from 15.08.2023 N 111)



I. Detailed information from the classifier

Document group code

Document type code

Name of the document

01

Documents drawn up when the applicant submits additional and clarifying information in the process of registration and examination of a medical device

0101

the request sent to the applicant indicating the nature of the comments

0102

Applicant's response indicating the nature of the comments

0103

Notification of the need to provide copies of documents evidencing payment of fees in the State of recognition

0104

notification of payment for the approval procedure sent by the applicant to the authorized body (expert organization) of the reference state

0105

notification of payment for the approval procedure sent by the applicant to the authorized bodies (expert organizations) of the State(s) of recognition

0106

documents submitted by the applicant containing a translation of the operating document or instructions for use of the medical device, service manual and labeling text into the official language(s) of the State(s) of recognition

0107

notification of the need to eliminate the identified violations and (or) submission of missing documents sent to the applicant

0108

notification of the return of registration and examination applications and documents to the applicant

0109

notification of the return to the applicant of additional materials and information submitted in response to the request

0110

Notice of return of the application for amendment of the registration dossier and documents

0111

Notice of return of the application for amendment of the registration dossier by notification and documents

0112

notification of return of the application for approval of the expert opinion and documents

0113

notification of return of the application for revocation (annulment) of the registration certificate and documents

0199

Other

(in edition of the decision of the Board of the Eurasian Economic Commission from 15.08.2023 N 111)

02

Documents drawn up by an authorized body of a member state of the Eurasian Economic Union based on the results of expert examination of the registration dossier of a medical device

0201

notification of refusal to register a medical device sent to the applicant

0202

notification of refusal to amend the registration dossier of the medical device sent to the applicant

0203

medical device registration certificate

0204

notification of medical device registration sent to the applicant

0205

Notice of amendment of the registration file sent to the applicant

0206

Notice of refusal to amend the registration file sent to the applicant

0207

A notice of refusal to amend the registration file by notice to the applicant

0208

Notice of amendment of the registration file by notice to the applicant

0209

notification of refusal to register a medical device by the state of recognition specified in the application for approval of the expert opinion, sent to the applicant

0210

notification of registration of the medical device by the state of recognition indicated in the application for approval of the expert opinion, sent to the applicant

0299

other

(in edition of the decision of the Board of the Eurasian Economic Commission from 15.08.2023 N 111)

03

Documents to be drawn up during production inspection in the process of registration of a medical device

 

0301

order for inspection of the production site

0302

site inspection report

0303

documents of the registration dossier for the medical device being registered, which have been amended based on the results of the manufacturing inspection, sent by the inspecting organization

0399

other

(in edition of the decision of the Board of the Eurasian Economic Commission from 15.08.2023 N 111)

04

Documents drawn up in the process of interaction between authorized bodies (expert organizations) of member States of the Eurasian Economic Union when considering the registration dossier of a medical device

0401

Expert opinion on the assessment of safety, efficacy and quality of a medical device during registration

0402

expert opinion on the possibility (impossibility) of making changes to the registration dossier of the medical product

0403

conclusion on confirmation of approval (non-approval) of the expert opinion on the results of expert examination of safety, quality and effectiveness of a medical device of a member state of the Eurasian Economic Union, which carries out registration of a medical device, in the course of registration

0404

conclusion on confirmation of approval (non-approval) of the expert opinion on the results of expert examination of safety, quality and efficacy of a medical device of a member state of the Eurasian Economic Union, which carries out registration of a medical device, when making changes to the registration dossier

0405

request for clarifying information sent by the authorized body (expert organization) of the state of recognition to the authorized body (expert organization) of the reference state

0406

response of the authorized body (expert organization) of the reference state to the request of the authorized body (expert organization) of the recognition state

0407

conclusion on confirmation of approval (non-approval) of the expert opinion on the results of expert examination of safety, quality and effectiveness of a medical device of a member state of the Eurasian Economic Union, which carries out registration of a medical device, in case of approval of an expert opinion on a registered medical device

0499

other

(in edition of the decision of the Board of the Eurasian Economic Commission from 15.08.2023 N 111)

05

Documents to be executed in the process of dispute settlement

0501

a statement by an authorized body (expert organization) of a member state of the Eurasian Economic Union on the need for the Advisory Committee on Medical Devices to consider disagreements

0502

Recommendation (protocol decision) of the Advisory Committee on Medical Devices

0503

notification of the meeting to settle disagreements sent by the Medical Devices Advisory Committee to the authorized bodies (expert organizations)

0504

the applicant's response to the notification of the need to coordinate an appeal to the Advisory Committee on Medical Devices to resolve disagreements regarding the approval of the expert opinion

0505

Notification to the applicant of the need to coordinate an appeal to the Advisory Committee on Medical Devices to resolve disagreements regarding the approval of the expert opinion.

0599

other

(in edition of the decision of the Board of the Eurasian Economic Commission from 15.08.2023 N 111)

06

Documents drawn up in the process of circulation of a medical device in the territories of member states of the Eurasian Economic Union

0601

decision to suspend the validity of the registration certificate of a medical device

0602

decision to cancel the validity (revocation) of the registration certificate of a medical device

0603

decision on renewal of the validity of the registration certificate of a medical device

0604

notification of the applicant on renewal of the validity of the registration certificate of a medical device

0605

notification of the applicant on cancellation (revocation) of the registration certificate of a medical device

0606

notification of the applicant on cancellation of registration of a medical device (models (brands) of a medical device, information about which is provided in the registration certificate of a medical device)

0699

other

(in edition of the decision of the Board of the Eurasian Economic Commission from 15.08.2023 N 111)

99

Other documents

 

9999

other

II. Classifier passport

N n/a

Element designation

Description

1

2

3

1

Code

043

2

Type

2 - classifier

3

Name

classifier of types of documents to be executed when reviewing the registration dossier of a medical device

4

Abbreviation

CWDORDMI.

5

Designation

EC 043-2023 (ed. 2).

(in edition of the decision of the Board of the Eurasian Economic Commission from 15.08.2023 N 111)

6

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

Decision of the Board of the Eurasian Economic Commission of August 21, 2018 N 135

7

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

from the date of entry into force of the Decision of the Board of the Eurasian Economic Commission of August 21, 2018 N 135

8

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

-

9

Date of termination of reference (classifier) application

-

10

Operator(s)

RU, Federal Service for Supervision in the Sphere of Healthcare

11

Assignment

is intended for classification and coding of types of documents to be drawn up when reviewing the registration dossier of a medical device in order to carry out its registration and related procedures

12

Annotation

(scope of application)

is used in the formation of documents submitted by participants in the circulation of medical devices to the state authorities of member states of the Eurasian Economic Union, including in electronic form, as well as to ensure information interaction in the implementation of common processes within the Eurasian Economic Union

13

Keywords

document, registration dossier, medical device registration

14

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

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

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

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

17

Method of systematization (classification)

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

18

Methodology

1 - centralized maintenance procedure. Adding, changing or excluding the values of the classifier is performed by the operator in accordance with the act of the Eurasian Economic Commission. The operator ensures the placement of up-to-date information in the resources of the unified system of normative and reference information of the Eurasian Economic Union. In case of exclusion of a value, the classifier record is marked as inactive from the date of exclusion with the indication of information about the act of the Eurasian Economic Commission, regulating the termination of the classifier record. Classifier codes are unique, reuse of classifier codes, 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 given in Section III of this classifier

20

Degree of data confidentiality

information from the classifier refers to open access information

21

Established periodicity of review

undetermined

22

Changes

-

23

Reference to detailed information from the directory (classifier)

detailed information from the classifier is given 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

III. Description of the classifier structure


1. This Section establishes requirements to the structure of the classifier, including determining the requisite composition and structure of the classifier, areas of requisite values and rules of their formation.
2. The structure and requisite composition of the classifier are given in the table, in which the following fields (columns) are formed:
"props value area" - text explaining the meaning (semantics) of the element;
"rules for forming the value of a requisite" - a text specifying the purpose of an element and defining the rules of its formation (filling), or a verbal description of possible values of the element;
"mn." - multiplicity of requisites (mandatory (optional) and number of possible repetitions of a requisite).
3. The following designations shall be used to indicate the plurality of details of the data to be transmitted:
1 - the prop is mandatory, repetitions are not allowed;
n - this requisite is mandatory and must be repeated n times (n > 1);
1..* - the requisite is mandatory, can be repeated without restrictions;
n..* - this requisite is mandatory and must be repeated at least n times (n > 1);
n..m - the requisite is mandatory, must be repeated at least n times and not more than m times (n > 1, m > n);
0..1 - the requisite is optional, repetitions are not allowed;
0..* - the requisite is optional, can be repeated without restrictions;
0..m - the prop is optional, can be repeated not more than m times (m > 1).

Table


Structure and requisite composition of the classifier

Name of requisite

Props value area

Rules for forming the value of a requisite

Mn.

 

1. Information on the types of documents to be drawn up when reviewing the registration dossier of a medical device

is determined by the value areas of the nested requisites

are determined by the rules of formation of nested details

1..*

 

1.1 Code of the section of the classifier of types of documents to be drawn up when reviewing the registration dossier of a medical device

normalized character string.
Template: \d{4}

the code designation is formed using a sequential coding method

1

 

1.2 Name of the section of the classifier of types of documents to be drawn up when reviewing the registration dossier of a medical device

a string of characters.
Min. length: 1.
Max. length: 1000

is formed in the form of a word combination in the Russian language

1

 

1.3 Information on the type of document to be drawn up when reviewing the registration dossier of a medical device

is determined by the value areas of the nested requisites

are determined by the rules of formation of nested details

1..*

 

 

1.3.1 Code of the type of document to be executed when reviewing the registration dossier of the medical device

normalized character string.
Template: \d{4}

the code designation is formed using a sequential coding method

1

 

 

1.3.2 Name of type of document to be executed when reviewing the registration dossier of a medical device

a string of characters.
Min. length: 1.
Max. length: 1000

is formed in the form of word combination in Russian language

1

 

 

1.3.3 Information about the directory (classifier) entry

is determined by the value areas of the nested requisites

are determined by the rules of formation of nested details

1

 

 

 

*.1 Effective date

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

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

1

 

 

 

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

is determined by the value areas of the nested requisites

are determined by the rules of formation of nested details

0..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

a string of characters.
Min. length: 1.
Max. length: 50

corresponds to the number of the act of the Eurasian Economic Union authority

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 body

1

 

 

 

*.3. Expiration date

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 on act regulating the expiration of the directory (classifier) record

is defined by areas of values of nested requisites

are determined by rules of forming nested details

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

a string of characters.
Min. length: 1.
Max. length: 50

corresponds to the number of the act of the Eurasian Economic Union authority

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 body

1
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