No. 62 Decision of the Board of the Eurasian Economic Commission dated April 16, 2019

Decision of the Board of the Eurasian Economic Commission dated April 16, 2019 No. 62

"On the Classifier of Areas of Medical Use of Medical Devices"

BOARD OF THE EURASIAN ECONOMIC COMMISSION

DECISION

dated April 16, 2019 N 62

CLASSIFIER

AREAS OF MEDICAL USE OF MEDICAL DEVICES

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 areas of medical application of medical devices (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 April 16, 2019 N 62

CLASSIFICATOR

AREAS OF MEDICAL USE OF MEDICAL DEVICES

I. Detailed information from the classifier

Code	Name of the area of medical application of medical devices
0100300	emergency medical care
0200200	andrology
0200300	obstetrics and gynecology
0200400	allergology and immunology
0200500	anesthesiology and resuscitation
0200600	bacteriology
0201000	gastroenterology
0201100	hematology
0201200	genetics
0201400	histology
0201600	dermatovenerology
0201900	infectious diseases
0202000	cardiology
0202300	coloproctology
0202400	cosmetology
0202800	sports medicine
0202900	physical therapy
0203300	medical massage
0203400	medical rehabilitation
0203500	addiction medicine
0203600	neurology
0203700	neonatology
0203800	nephrology
0203900	oncology
0204100	otorhinolaryngology
0204200	ophthalmology
0204400	pediatrics
0204600	psychiatry
0204800	pulmonology
0204900	radiology
0205000	radiotherapy
0205100	intensive care
0205200	rheumatology
0205300	radiology
0205400	endovascular therapy
0205500	reflexotherapy
0205800	dentistry
0206000	therapy
0206100	toxicology
0206200	traumatology and orthopedics
0206300	transfusiology
0206400	urology
0206500	physiotherapy
0206600	phthisiology
0206700	surgery
0206701	angiosurgery
0206704	plastic surgery
0206705	neurosurgery
0206708	surgery (combustiology)
0206711	maxillofacial surgery
0206713	cardiovascular surgery
0206800	endocrinology
0206900	endoscopy
0300200	laboratory diagnostics
0300400	radial diagnostics
0300500	pathological anatomy
0300600	ultrasonic diagnostics
0300700	functional diagnostics
0400000	transplantology
9999999	other

II. Classifier passport

N n/a	Element designation	Description
1	2	3
1	Code	048
2	Type	2 - classifier
3	Name	classifier of areas of medical application of medical devices
4	Abbreviation	COMPMI
5	Designation	EC 048-2019 (rev. 1)
6	Details of the act on adoption (approval) of the directory (classifier)	Decision of the Board of the Eurasian Economic Commission of April 16, 2019 N 62
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 April 16, 2019 N 62
8	Details of the act on termination of application of the directory (classifier)	-
9	Date of termination of reference (classifier) application	-
10	Operator(s)	KG, Ministry of Health of the Kyrgyz Republic
11	Assignment	is designed to provide information on the areas of medical use of a medical device when compiling documents of the registration dossier of a medical device and ensuring information interaction in the implementation of common processes within the Eurasian Economic Union
12	Abstract (scope of application)	is used in the execution of documents (including in electronic form) submitted by participants in the circulation of medical devices to the state authorities of the Eurasian Economic Union member states, as well as to ensure information interaction in the implementation of common processes within the Eurasian Economic Union
13	Keywords	medical application of medical devices
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 method of classification
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. Codes of the classifier records are unique, reuse of the codes of the 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 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 defines the structure and requisite composition of the classifier, including the areas of requisite values and the 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 a requisite (mandatory (optional) and number of possible repetitions of the 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, no repetitions are 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 classifier

Name of requisite				Props value area	Rules for forming the value of a requisite	Mn.
1. Information on the field of medical application of medical devices				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 field of medical application of medical devices			normalized character string. Template: \d {3}	the code designation is formed using the serial-order coding method	1
	1.2 Name of the field of medical application of medical devices			normalized character string. Min. length: 1. Max. length: 500	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	0..1
			*.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. 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 classifier 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 in accordance with GOST ISO 8601-2001 in the format YYYYY-MM-DD	corresponds to the date of adoption of the act of body of the Eurasian Economic Union	1