Decision of the Board of the Eurasian Economic Commission dated August 21, 2018 No. 134

"On the Directory of Types of Changes Made to the Registration Dossier of a Medical Device"



BOARD OF THE EURASIAN ECONOMIC COMMISSION

DECISION

dated August 21, 2018 N 134.

ABOUT THE DIRECTORY

TYPES OF AMENDMENTS TO THE REGISTRATION DOSSIER

MEDICAL DEVICE


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 guide of types of changes to be made to the registration dossier of a medical device (hereinafter referred to as the guide).
2. To include the directory in the resources of the unified system of normative and reference information of the Eurasian Economic Union.
3. Establish that:
the handbook shall apply from the date of entry into force of this Decision;
the use of code designations of the directory is mandatory for the implementation of 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 134.


BOOK

TYPES OF AMENDMENTS TO THE REGISTRATION DOSSIER

MEDICAL DEVICE


I. Detailed information from the handbook

Code

Name of the type of change to be made to the registration dossier of a medical device

05

change of name of medical device

10

change in the composition of accessories, and (or) components, and (or) consumables

15

change of information on indications for use, scope of application, contraindications, side effects

20

change of information about the manufacturer of the medical device

25

change of information contained in the technical and (or) operational documentation for the medical device

30

change of information on the applicant, including information on reorganization of a legal entity, change of its name or surname, name and residence address of an individual entrepreneur

99

other

II. Passport of the directory

N n/a

Element designation

Description

1

Code

017

2

Type

1 - handbook

3

Name

Directory of types of changes to the registration dossier of a medical device

4

Abbreviation

SWIRDMY.

5

Designation

EC 017-2018 (rev. 1)

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 134

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 134

8

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

-

9

Date of termination of reference (classifier) application

-

10

Operator(s)

KZ, Ministry of Health of the Republic of Kazakhstan

11

Assignment

is intended to provide information on the types of changes made to the registration dossier of a medical device

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

amendments to the registration dossier, medical device

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) directories and (or) standards were not used in the development of the handbook

16

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

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

17

Method of systematization (classification)

1 - ordinal method of systematization

18

Methodology

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

19

Structure

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

20

Degree of data confidentiality

Directory information is publicly available information

21

Established periodicity of review

undetermined

22

Changes

-

23

Reference to detailed information from the directory (classifier)

detailed information from the handbook is provided in Section I of this handbook

24

Method of presentation of information from the directory (classifier)

publication on the information portal of the Eurasian Economic Union

III. Description of the directory structure


1. This section establishes the requirements to the structure of the directory, including determining the requisite composition and structure of the directory, areas of requisite values and rules of their formation.
2. The structure and requisite composition of the directory 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 prop 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 directory

Name of requisite

Props value area

Rules for forming the value of a requisite

Mn.

1. Information on the type of amendment to be made to 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 type of change to be made to the registration dossier of the medical device

normalized character string.
Template: \d{2}

the code designation is formed using the serial-order coding method

1

1.2 Name of the type of change to be made to the registration dossier of the medical device

normalized character string.
Min. length: 1.
Max. length: 4000

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

1

1.3 Information about the directory (classifier) record

is determined by the value areas of the nested requisites

are determined by the rules of formation of nested details

1

1.3.1 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

1.3.2 Information about 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

1

*.1 Type of act

normalized character string.
Template: \d{5}

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

0..1

*.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

*.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

1.3.3 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

1.3.4 Information on the act regulating the expiration of the directory (classifier) entry

is determined by the value areas of the nested requisites

are determined by the rules of formation of nested details

0..1

*.1 Type of act

normalized character string.
Template: \d{5}

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

1

*.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

*.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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