Decision of the Board of the Eurasian Economic Commission dated June 30, 2017 No. 78

(as amended on February 28, 2023)

"On the Requirements for the Electronic Format of Applications and Documents of the Registration Dossier Submitted for the Registration and Examination of the Safety, Quality, and Effectiveness of Medical Devices"




BOARD OF THE EURASIAN ECONOMIC COMMISSION


DECISION

dated June 30, 2017. N 78


ABOUT THE REQUIREMENTS

TO THE ELECTRONIC FORM OF APPLICATIONS AND REGISTRATION DOCUMENTS

FILES TO BE SUBMITTED IN THE COURSE OF THE REGISTRATION PROCESS

AND EXPERTISE IN SAFETY, QUALITY AND EFFICIENCY

MEDICAL DEVICES




List of amending documents

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

from 28.02.2023 N 20)



In accordance with paragraph 11 of the Protocol on Information and Communication Technologies and Information Interaction within the Eurasian Economic Union (Annex N 3 to the Treaty on the Eurasian Economic Union of May 29, 2014) and the Rules for Registration and Examination of Safety, Quality and Effectiveness of Medical Devices, approved by the Decision of the Council of the Eurasian Economic Commission of February 12, 2016. N 46 (hereinafter - the Registration Rules), the Board of the Eurasian Economic Commission decided:
1. To approve the attached Requirements to the electronic form of applications and documents of the registration dossier submitted in the course of registration and examination of safety, quality and effectiveness of medical devices (hereinafter referred to as the Requirements).
2. Establish that the development of technical schemes of electronic document structures provided for by the Requirements and ensuring their placement in the register of electronic document structures and information published on the official website of the Eurasian Economic Union (hereinafter - the Union) shall be carried out by the department of the Eurasian Economic Commission, whose competence includes the coordination of work on the creation and development of the integrated information system of the Union.
3. To establish that when realizing in the Member States of the Union the electronic form of interaction when performing procedures according to the Registration Rules, documents in electronic form provided by the Requirements shall be applied in accordance with the technical schemes of structures of such documents contained in the register of structures of electronic documents and information.
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 June 30, 2017. N 78


REQUIREMENTS

TO THE ELECTRONIC FORM OF APPLICATIONS AND REGISTRATION DOCUMENTS

FILES TO BE SUBMITTED IN THE COURSE OF THE REGISTRATION PROCESS

AND EXPERTISE IN SAFETY, QUALITY AND EFFICIENCY

MEDICAL DEVICES




List of amending documents

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

from 28.02.2023 N 20)



I. General provisions


1. These Requirements have been developed in order to create equal conditions for business entities of member states of the Eurasian Economic Union (hereinafter referred to as member states, the Union) to submit information in electronic form to authorized bodies of member states (expert organizations) when performing procedures for registration and expert examination of the safety, quality and effectiveness of medical devices.
2. The concepts used in these Requirements shall be applied in the meanings defined by the Protocol on Information and Communication Technologies and Information Interaction within the Eurasian Economic Union (Annex N 3 to the Treaty on the Eurasian Economic Union dated May 29, 2014) and the Rules for Registration and Expert Review of Safety, Quality and Effectiveness of Medical Devices approved by the Decision of the Council of the Eurasian Economic Commission dated February 12, 2016. N 46 (hereinafter - the Registration Rules, the Commission).
(3) These Requirements define the structure and rules for completing the documents in electronic form submitted by the applicant to the authorized bodies of the Member States when performing the procedures provided for in the Registration Rules.
4. The structure of the document in electronic form "Information on the application for registration of a medical device within the Eurasian Economic Union" (R.018) is intended for electronic submission of the following types of applications:
a) application for expert examination of a medical device within the Union - in accordance with Annex No. 2 to the Registration Rules (hereinafter - application for expert examination);
b) application for registration of a medical device within the Union, submitted in accordance with Annex No. 3 to the Registration Rules (hereinafter referred to as the registration application);
c) application for amendments to the registration dossier of a medical device within the Union, submitted in accordance with Annex No. 7 to the Registration Rules (hereinafter - application for amendments);
d) application for amendments to the registration dossier of a medical device under the notification procedure submitted in accordance with Annex No. 9 to the Registration Rules (hereinafter - application for amendments under the notification procedure);
e) application for cancellation (revocation) of the registration certificate of a medical device submitted in accordance with Annex No. 13 to the Registration Rules (hereinafter - application for revocation);
f) application for issuance of a duplicate of the registration certificate of a medical device submitted in accordance with Annex No. 10 to the Registration Rules (hereinafter - application for issuance of a duplicate);
g) application for approval of the expert opinion on the registered medical device submitted in accordance with Annex No. 11 to the Registration Rules (hereinafter - application for adherence).
5. The structure of the document in electronic form "Information on the documents of the registration dossier of a medical device or documents executed during the review of the registration dossier of a medical device" (R.020) is intended for electronic submission of documents of the registration dossier of a medical device in accordance with Annex No. 4 to the Registration Rules, as well as documents executed during the review of the registration dossier of a medical device.
6. The list of documents submitted by the applicant in electronic form shall be determined by the Registration Rules.
7. The documents specified in clauses 4 and 5 of these Requirements shall be electronically generated in XML-format in accordance with the standard "Extensible Markup Language (XML) 1.0 (Fifth Edition)" (published in the information and telecommunication network "Internet" at: http://www.w3.org/TR/REC-xml).
8. The electronic document structures specified in clauses 4 and 5 of these Requirements represent a set of requisites arranged in a hierarchical form. The requisites of electronic document structures may include 1 or several nested requisites.
9. Description of electronic document structures and rules of their filling are given in tabular form with indication of full requisite composition taking into account hierarchy levels up to simple (atomic) requisites (Tables 1 - 7 and 10).
10. The following designations in the column "Plurality" ("Mn.") in Tables 2 - 7 and 10 are used to indicate the mandatory filling of details:
0 - the requisite is not filled in;
1 - requisite;
0..1 - the requisite is optional, repetitions are not allowed;
0..* - the requisite is optional, can be repeated without restrictions;
1..* - the requisite is mandatory, can be repeated without restrictions;
n..m - the prop is mandatory, must be repeated at least n times and not more than m times (n > 1, m > n).
11. The column "Name of the requisite" shall contain the name of the requisite, as well as the name of the corresponding data element in brackets in the technical scheme of the document structure in electronic form, indicating the namespace prefix.

II. Requirements to the structure of the document in electronic form

"Information on the application for registration of a medical

products within the Eurasian Economic Union" (R.018)


12. The following designations shall be used to indicate the rules for filling in the requisites depending on the type of application:
1 - requisite;
0..1 - the requisite is optional, repetitions are not allowed;
0..* - the requisite is optional, can be repeated without restrictions;
1..* - the requisite is mandatory, can be repeated without restrictions.
If the designation is not specified, the requisite is not filled in for this type of application.
13. The composition of details of the structure of the electronic document "Information on the application for registration of a medical device within the Eurasian Economic Union" (R.018) and general rules for their completion depending on the type of application are shown in Table 1.
14. Requirements for the formation of XML documents in accordance with the structure of the electronic document "Information on the Application for Registration of a Medical Device within the Eurasian Economic Union" (R.018) are given in Table 8.

Table 1


Composition of details of the document structure in electronic form

"Information on the application for registration of a medical

products within the Eurasian Economic Union" (R.018)

Name of requisite

Rule of filling in the requisite

Applications for registration, examination

Application for change

Application for change in notification procedure

Application for annulment

Application for issuance of a duplicate

Application for accession

1. Code of electronic document (information)

(csdo:EDocCode)

the value "R.018" is specified

1

1

1

1

1

1

2. Identifier of the electronic document (information) (csdo:EDocId)

universal unique identifier - a normalized character string 36 characters long, uniquely identifying an electronic document

1

1

1

1

1

1

3. Date and time of the electronic document (information) (csdo:EDocDateTime)

date and time of creation of the electronic document in the format YYYYY-MM-DDThh:mm:ssZ

1

1

1

1

1

1

4. Information on application for medical device registration and (or) related procedures (hccdo:MedicalDeviceApplicationDetails)

information on the application for registration of a medical device and (or) registration-related procedures

1

1

1

1

1

1

 

4.1 Number of application for registration or other procedures related to registration of a medical product (hcsdo:MedicalProductApplicationId)

application number assigned by the authorized body of the reference state in the form of a normalized string of no more than 20 characters in length

0..1

0..1

0..1

0..1

0..1

0..1

 

4.2 Document Date (csdo:DocCreationDate)

date of application submission in the format YYYYYY-MM-DD

1

1

1

1

1

1

 

4.3 Reference Country Code (hcsdo:ReferenceUnifiedCountryCode)

two-letter code of the reference state in which the medical device is to be circulated, from the world country classifier according to the ISO 3166-1 standard.

1

1

1

1

1

1

 

 

(a) Directory (classifier) identifier

(codeListId attribute)

the value "P.CLS.019" is specified

1

1

1

1

1

1

 

4.4 Code of the State of Recognition

(hcsdo:RecognitionUnifiedCountryCode)

the two-letter code of the State of recognition in which the medical device is intended to be marketed, from of the World Country Classifier according to ISO 3166-1. The declaration of adherence may only contain the codes of the States of Recognition not indicated on the registration certificate

1..*

0..*

 

 

 

1..*

 

 

(a) Directory (classifier) identifier

(codeListId attribute)

the value "P.CLS.019" is specified

1

1

 

 

 

1

 

4.5 Code of the type of application for registration of a medical device and (or) related procedures (hcsdo:MedicalProductApplicationKindV2Code)

code of the type of the submitted application in accordance with the classifier of types of documents of the registration dossier of the medical device, approved by the decision of the Board of the Commission dated April 3, 2018 N 48

1

1

1

1

1

1

 

 

(a) Directory (classifier) identifier

(codeListId attribute)

the value "2048" is specified

 

 

 

 

 

 

 

4.6 Method code for receiving notifications (decisions) from authorized body of the reference state (hcsdo:MedicalProductNotificationMethodCode)

code of the method of receipt of notifications (decisions) from the authorized body (expert organization) of the reference state in accordance with the list of possible values:

01 - in person by signature;

02 - by registered mail with return receipt requested;

03 - in electronic form via telecommunication channels;

04 - in the form of an electronic document signed with an electronic signature. When selecting code "03" in the "Contact details" of the applicant, the e-mail address(es) to which the notifications should be sent must be obligatory specified

1

1

1

 

1

1

 

4.7 Method code for obtaining a registration certificate for a medical device (hcsdo:ReceptionKindCode)

code of the method of obtaining a registration certificate for a medical device in according to the list of possible values:

01 - on paper in person;

02 - on paper to be sent by registered mail with acknowledgement of receipt.

The examination application shall not be filled in

1

1

1

 

1

1

 

4.8 Reason for the applicant's application

(hcsdo:ReasonText)

description of the reason for cancellation (revocation) or the reason for applying for a duplicate of the registration certificate of a medical device in the form of a normalized string not exceeding 4000 characters in length

 

 

 

1

1

 

5. Information confirming the payment of the fee for registration of a medical device and (or) related procedures (hccdo:DutyProofDocDetails)

information on payment of fees for registration of a medical device and (or) registration-related procedures

1

1..*

1..*

 

1

1..*

 

5.1 Country code (csdo:UnifiedCountryCode)

two-letter code of the Member State from the World Country Classifier according to ISO 3166-1, to which the duty has been paid

1

1

1

 

1

1

 

 

(a) Directory (classifier) identifier

(codeListId attribute)

the value "P.CLS.019" is specified

1

1

1

 

1

1

 

5.2 The code of the type of fee for the registration of a medical device and (or) related procedures (hcsdo:DutyKindCode)

code of the type of duty according to the list of possible values:

01 - medical device examination fee;

02 - fee for carrying out the registration of a medical device;

03 - fee for examination of changes in the registration dossier;

04 - fee for issuance of a duplicate of the registration certificate of a medical device;

05 - fee for approval of expert opinion;

06 - fee for amendments to the registration dossier by notification;

07 - issuance of a registration certificate for a medical device

1

1

1

 

1

1

 

5.3 Document Name (csdo:DocName)

name of the document confirming the payment of the fee in the form of a normalized string not exceeding 500 characters in length

1

1

1

 

1

1

 

5.4 Document number (csdo:DocId)

the number of the document confirming the payment of the fee shall be indicated in the form of a normalized string not exceeding 50 characters in length

1

1

1

 

1

1

 

5.5 Document Date (csdo:DocCreationDate)

date of issue of the document confirming payment of the fee, in the format YYYYY-MM-DD

1

1

1

 

1

1

6. Information on the registration of the medical device in the Union, the country of manufacture or a third country

(hccdo:RegistrationDetails)

information on the registration of the medical device in the Union, the country manufacturer or a third country. The application for registration shall not be filled in

0..*

1

1

1

1

1

 

6.1 Sign of registration of the medical product in the Union (hcsdo:MedicalProductEAEURegistrationIndicator)

an attribute that determines the registration of a medical device in the Union:

1 - registration of the medical device in the Union;

0 - registration in the country of manufacture or a third country

1

1

1

1

1

1

 

6.2 Country Code (csdo:UnifiedCountryCode)

the two-letter country code from the ISO 3166-1 world country classifier in which the medical device is registered.

0..1

 

 

 

 

 

 

 

(a) Directory (classifier) identifier

(codeListId attribute)

the value "P.CLS.019" is specified

1

 

 

 

 

 

 

6.3 Number of registration certificate

(hcsdo:RegistrationCertificateId)

unique number of the registration certificate of the medical device in the form of a normalized string of not more than 50 characters in length

0..1

1

1

1

1

1

 

6.4 Document Date (csdo:DocCreationDate)

date of issue of the registration certificate of the medical device in the format YYYYY-MM-DD

0..1

 

 

1

 

1

 

6.5 Validity period of the document

(csdo:DocValidityDuration)

duration of validity of the registration certificate of a medical device in format

P1Y2M3DT10H30M

0..1

 

 

 

 

 

7. Registered medical device

(hccdo:RegisteredMedicalDeviceDetails)

medical device information

1

1

1

1

1

1

 

7.1 Name of medical device

(hcsdo:MedicalProductName)

name of the medical product in the form of a normalized string not exceeding 500 characters in length; the value of the requisite must not coincide with the name of medical products in existing records of the register of medical products and in existing records of the register of medicines, as well as must not coincide with the name of biologically active food supplements, information about which is contained in the unified register of certificates of state registration of products

1

1

1

1

1

1

 

7.2 Description of the medical device purpose (hcsdo:DevicePurposeText)

information on the purpose of the medical device in the form of a normalized string of no more than 4000 characters in length

1

 

 

 

 

 

 

7.3 Medical Product Usage Code (hcsdo:MedicalProductUsageCode)

code of the field of application in accordance with the classifier of fields of medical application of a medical device, approved by the decision of the Board of the Commission of April 16, 2019 N 62

1

 

 

 

 

 

 

 

(a) Directory (classifier) identifier

(codeListId attribute)

the value "048" shall be specified

1

 

 

 

 

 

 

7.4 Potential risk class code for the medical device

(hcsdo:RiskClassCode)

code of the potential risk class of the medical device according to the list of possible values:

1 - is a low degree;

2a - is the middle degree;

2b - is an elevated degree;

3 - high degree

1

1

1

 

 

1

 

7.5 Medical device type code

(hcsdo:MedicalProductClassificationCode)

code designation of the type of medical device in accordance with the nomenclature of medical devices used in the Eurasian Economic Union, approved by the Decision of the Board of the Commission dated April 3, 2018 N 46. At least one of the details in lines 7.5 and 7.6.2 must be completed

0..1

0..1

0..1

 

 

0..1

 

 

(a) Directory (classifier) identifier

(codeListId attribute)

the value "2036" is specified

1

1

1

 

 

1

 

7.6 Information on the model (brand) of the medical product (hccdo:MedicalProductModificationDetails)

information on the model (brand) of the medical device

0..*

 

 

0..*

0..*

 

 

 

7.6.1 Name of medical product model (brand) (hcsdo:MedicalProductModificationName)

name of the model (brand) of the medical product in the form of a normalized string of not more than 500 characters in length

1

 

 

1

1

 

 

 

7.6.2 Medical device type code

(hcsdo:MedicalProductClassificationCode)

code designation of the type of medical device of the brand (model) in accordance with the nomenclature of medical devices used in the Eurasian Economic Union, approved by the Decision of the Board of the Commission dated April 3, 2018 N 46

0..1

 

 

 

 

 

 

 

 

(a) Directory (classifier) identifier

(codeListId attribute)

the value "2036" is specified

1

 

 

 

 

 

 

 

7.6.3 Information on the composition of the medical product (hccdo:MedicalProductSetDetails)

information on the composition of the medical device

0..*

 

 

0..*

0..*

 

 

 

 

*.1 Name of the component part of the medical device (hcsdo:ModelNumberSetName)

i

name of the component part of the medical device in the form of a normalized string of not more than 500 characters in length

1

 

 

1

1

 

 

 

 

*.2 Name of the business entity (csdo:BusinessEntityName)

name of the manufacturer of the medical device component part in the form of a normalized string of not more than 300 characters in length

1

 

 

 

 

 

 

 

 

*.3. country code

(csdo:UnifiedCountryCode)

two-letter code of the country of manufacture of the component part of the medical device, from the world country classifier according to ISO 3166-1 standard

1

 

 

 

 

 

 

 

 

 

(a) Directory (classifier) identifier

(codeListId attribute)

the value "P.CLS.019" is specified

1

 

 

 

 

 

 

 

7.6.4 Information on medical product accessory (hccdo:MedicalProductAccessoryDetails)

information on medical device accessories

0..*

 

 

0..*

0..*

 

 

 

 

*.1 Name of medical product accessory (hcsdo:MedicalProductAccessoryName)

name of the medical device accessory in the form of a normalized string with a maximum length of 500 characters

1

 

 

1

1

 

 

 

 

*.2 Name of the business entity

(csdo:BusinessEntityName)

name of the manufacturer of the accessory in the form of a normalized string of not more than 300 characters in length

1

 

 

 

 

 

*.3. country code

(csdo:UnifiedCountryCode)

two-letter code of the country of manufacture of the accessory, from the world country code according to ISO 3166-1.

1

 

 

 

 

 

 

 

 

 

(a) Directory (classifier) identifier

(codeListId attribute)

the value "P.CLS.019" is specified

1

 

 

 

 

 

 

7.7 Indication of the presence of a medicinal product in a medical device

(hcsdo:MedicalDrugAvailabilityIndicator)

an attribute that identifies the presence of a medicinal product in a medical device:

1 - the medical device contains a medicinal product;

0 - there is no medicinal product in the composition of the medical device

1

 

 

 

 

 

 

7.8 Shelf life of the medical device

(hcsdo:MedicalProductStorageDuration)

duration of shelf life of the medical device in the format P1Y2M3DT10H30M. To be specified only in the application for examination

1

 

 

 

 

 

 

7.9 Medical Product Warranty Duration (hcsdo:MedicalProductWarrantyDuration)

duration of the warranty period of the medical device in the format of

P1Y2M3DT10H30M. To be specified only in the statement of expertise

1

 

 

 

 

 

 

7.10 Description of the medical product storage conditions (hcsdo:MedicalProductStorageConditionsText)

description of storage conditions of the medical device in the form of normalized string not more than 4000 characters long. To be specified only in the application for examination

1

 

 

 

 

 

 

7.11. Indication of use of medical product for in vitro diagnostics (hcsdo:MedicalProductInVitroDiagnosticsIndicator)

an attribute that determines whether a medical device can be used for in vitro diagnostics:

1 - the medical device is used for in vitro diagnostics;

0 - medical device is not used for in vitro diagnostics

1

 

 

 

 

 

8. Information on the production of the medical device being registered

(hccdo:MedicalDeviceManufacturingDetails)

information on the manufacture of the medical device

1

1

1

0..1

1

1

 

8.1 Code of the degree of participation of the organization in the manufacture of the medical device (hcsdo:ManufactureParticipationDegreeCode)

code of the degree of participation of the organization in the production of the medical device in accordance with the list of degrees of possible values:

01 - is entirely on this production;

02 - in part on this production;

03 - is entirely on another production.

Specified only in the statement of expertise

1

 

 

 

 

 

 

8.2 Information on the manufacturer of the medical device being registered

(hccdo:MedicalDeviceManufacturerDetails)

information on the manufacturer of the medical device. The composition of details and the rules for their completion are given in Table 2. Information on the authorized representative shall be obligatory filled in in the application for cancellation, if not filled in

1

1

1

0..1

1

1

 

8.3 Information on the manufacturing site of the registered medical device (hccdo:MedicalDeviceManufacturingAreaDetails)

information on the production site of the medical device. The composition of requisites and rules of their filling are given in Table 2

0..*

0..*

0..*

 

0..*

0..*

9. Information on the authorized representative of the manufacturer of medical devices (hccdo:MedicalDeviceRepresentativeDetails)

information on the authorized representative of the manufacturer of medical device. The composition of requisites and rules of their filling are given in Table 2

0..1

0..1

0..1

0..1

0..1

0..1

10. Indication of the need for production inspection

(hcsdo:MedicalProductQMSInspectionIndicator)

indicates the indication of the need for inspection if the medical device to be registered is a medical device of potential application risk class 1 or a non-sterile medical device of potential application risk class 2a and the initial manufacturing inspection has not been previously performed:

1 - inspections should be carried out

0 - should not be carried out

1

 

 

 

 

 

11. document number (csdo:DocId)

Production inspection report number in the form of a normalized string not more than 50 characters long

 

 

0..*

 

 

 

12. organization name (csdo:OrganizationName)

full name of the inspecting organization in the form of a normalized string of not more than 300 characters in length

 

 

0..*

 

 

 

13. Information on changes made to the registration dossier of a medical device (hccdo:RegistrationDossierChangingDetails)

information on changes made to the registration dossier of the medical device

 

1..*

1..*

 

 

 

 

13.1 Description of the information on the registration file before amendment

(hcsdo:RegistrationDossierInitialDescriptionText)

a description of the information of the registration dossier prior to amendments in the form of a normalized string not exceeding 4000 characters in length

 

0..1

0..1

 

 

 

 

13.2 Description of the information of the registration dossier after amendments (hcsdo:RegistrationDossierChangelDescriptionText)

description of the data of the registration after the amendment in the form of a normalized string of not more than 4000 characters in length

 

0..1

0..1

 

 

 

Table 2


Description of the composition of details "Information

on the manufacturer of the medical device being registered",

"Information about the production site of the registrant

medical device" and "Information on the authorized person

medical device manufacturer's representative"

Name of requisite

Rule of filling in the requisite

Mn.

1. Information about the business entity (hccdo:BusinessEntityExpandedDetails)

composition of requisites and rules of their filling are given in Table 3

0..1

2. Information about the authorization document (hccdo:ManufacturePermitDocDetails)

composition of requisites and rules of their filling are given in Table 6

0..1

3. Officer details (hccdo:OfficerDetails)

composition of requisites and rules of their filling are given in Table 7

1..*

Table 3


Description of the composition of the requisite "Information

of a business entity."

Name of requisite

Rule of filling in the requisite

Mn.

1. Country code (csdo:UnifiedCountryCode)

country code of the business entity from the world country classifier in accordance with ISO 3166-1;

within the information on the authorized representative, the requisite "Country code" shall be filled in obligatory and its value shall correspond to the code of the Union Member State;

The "Country Code" requisite is obligatory to be filled in as part of the information on the manufacturer;

if the value of the requisite "Country code" in the information on the manufacturer does not correspond to the code of the Union member state, the information on the authorized representative shall be filled in obligatory

1

 

(a) Directory (classifier) identifier (codeListId attribute)

the value "P.CLS.019" is specified

1

2. Name of the business entity (csdo:BusinessEntityName)

full name of the business entity in the form of a normalized string of not more than 300 characters in length

0..1

3. Brief name of the business entity (csdo:BusinessEntityBriefName)

short or company name of the business entity in the form of a normalized string of no more than 120 characters in length

0..1

4. Code of legal form of organization (csdo:BusinessEntityTypeCode)

code of the legal form in accordance with the classifier of legal forms approved by the decision of the Board of the Commission from April 2, 2019 N 54

0..1

 

(a) Directory (classifier) identifier (codeListId attribute)

the value "2049" is specified

1

5. Name of the legal form of organization (csdo:BusinessEntityTypeName)

if requisite "4. Code of the organizational-legal form" is not filled in, the name of the organizational-legal form of the organization shall be indicated in the form of a normalized string of not more than 120 characters in length.

0..1

6. Business entity identifier (csdo:BusinessEntityId)

number (code) of an entry in the register (register) of a business entity assigned during state registration in the form of a normalized string of no more than 20 characters in length

0..1

 

(a) Method of identification (attribute kindId)

before the directory of methods of identification of business entities is included in the resources of the Union's unified regulatory and reference information system, the code of the method of identification of business entities shall be specified in accordance with the list of possible values:

1

01 - BIN (Business Identification Number of the Republic of Kazakhstan);

02 - GRYUL (state registration code of legal entities of the Republic of Armenia);

03 - OGRN (main state registration number in the Russian Federation);

04 - OGRNIP (main state registration number of an individual entrepreneur in the Russian Federation);

05 - OKOGU (code of the All-State Classifier of the Republic of Belarus "Bodies of State Power and Administration");

06 - OKPO (code of the All-Republican Classifier of Enterprises and Organizations of the Kyrgyz Republic);

07 - OKJLP (code of the National Classifier of the Republic of Belarus "Legal Entities and Individual Entrepreneurs")

7. Unique Customs Identification Number (csdo:UniqueCustomsNumberId)

The unique identification number of the economic entity intended for the purposes of customs control shall be indicated in the form of a normalized string not more than 17 characters long

0..1

8. Taxpayer Identifier (csdo:TaxpayerId)

the identifier of the business entity in the register of taxpayers of the country of the taxpayer's registration in the form of a normalized string of not more than 20 characters in length is indicated

0..1

9. Tax Registration Reason Code (csdo:TaxRegistrationReasonCode)

a 9-character numeric code identifying the reason for the business entity's tax registration in the Russian Federation is indicated

0..1

10. Address (ccdo:AddressV4Details)

composition of requisites and rules of their filling are given in Table 4

0..*

11. Contact details (ccdo:CommunicationDetails)

composition of requisites and rules of their filling are given in Table 5

0..*

Table 4


Description of the composition of the "Address" requisite

Name of requisite

Rule of filling in the requisite

Mn.

1. Address Kind Code (csdo:AddressKindCode)

address type code according to the list of possible values:

01 - address of incorporation;

02 - actual address;

03 - postal address

0..1

2. Country code (csdo:UnifiedCountryCode)

two-letter country code from the world country classifier according to ISO 3166-1 standard

0..1

 

(a) Directory (classifier) identifier (codeListId attribute)

the value "P.CLS.019" is specified

1

3. Territory code (csdo:TerritoryCode)

code of the unit of administrative-territorial division in the form of a normalized string of not more than 17 characters in length

0..1

4. Region (csdo:RegionName)

name of the region in the form of a normalized string of no more than 120 characters in length

0..1

5. Neighborhood (csdo:DistrictName)

name of the district in the form of a normalized string of no more than 120 characters in length

0..1

6. City (csdo:CityName)

name of the city in the form of a normalized string of no more than 120 characters in length

0..1

7. Settlement (csdo:SettlementName)

if requisite "6. City" is not filled in, the name of the settlement shall be indicated in the form of a normalized string not more than 120 characters long

0..1

8. Street (csdo:StreetName)

street name as a normalized string of no more than 120 characters in length

0..1

9. Building number (csdo:BuildingNumberId)

designation of a house, building, structure in the form of a normalized string of not more than 50 characters in length

0..1

10. Room number (csdo:RoomNumberId)

designation of office or apartment in the form of a normalized string of no more than 20 characters in length

0..1

11. Postal code (csdo:PostCode)

postal code in the form of a normalized string consisting of capital letters of the Latin alphabet or digits, which may be separated by a hyphen

0..1

12. P.O. Box number (csdo:PostOfficeBoxId)

P.O. Box number at the postal service company as a normalized string of no more than 20 characters in length

0..1

13. Address in text form (csdo:AddressText)

a set of address elements presented in free form as a normalized string of not more than 1000 characters in length

0..1

Table 5


Description of composition of the "Contact details" requisite

Name of requisite

Rule of filling in the requisite

Mn.

1. Type of communication code

(csdo:CommunicationChannelCode)

the code of the type of communication according to the list of possible values:

AO - address of the site in the information and telecommunication network of the Internet;

EM - e-mail;

FX - telefax;

TE - telephone;

TG - telegraph;

TL - telex

0..1

2. Name of the type of communication

(csdo:CommunicationChannelName)

if requisite "1. Code of type of communication" is not filled in, the name of one of the types of communication ("e-mail", "telefax", "telephone", etc.) shall be indicated in the form of a normalized string not more than 120 characters long

0..1

3. Communication channel identifier

(csdo:CommunicationChannelId)

telephone number, fax number or e-mail address, depending on the type of communication indicated, in the form of a normalized string of no more than 1000 characters in length

1..*

Table 6


Description of the composition of the requisite "Information

about the authorization document."

Name of requisite

Rule of filling in the requisite

Mn.

1. Name of the document

(csdo:DocName)

name of the authorization document in the form of a normalized string of no more than 500 characters in length

1

2. Document number

(csdo:DocId)

number of the authorization document in the form of a normalized string of no more than 50 characters in length

1

3. Document date

(csdo:DocCreationDate)

date of issuance of the authorization document in the format YYYYY-MM-DD

1

4. Document Validity Duration

(csdo:DocValidityDuration)

validity period of the authorization document in the format P1Y2M3DT10H30M

0..1

Table 7


Description of the composition of the "Information about the employee" requisite

Name of requisite

Rule of filling in the requisite

Mn.

1. NAME

(ccdo:FullNameDetails)

Name, surname, first name and patronymic of the employee

1
 

1.1 Name

(csdo:FirstName)

Employee name as a normalized string of up to 120 characters in length

0..1
 

1.2 Patronymic

(csdo:MiddleName)

employee's patronymic in the form of a normalized string of no more than 120 characters in length

0..1
 

1.3 LastName

(csdo:LastName)

employee's surname in the form of a normalized string of no more than 120 characters in length

0..1

2. Country Code

(csdo:UnifiedCountryCode)

two-letter country code from the world country classifier according to ISO 3166-1 standard

1
 

(a) Directory (classifier) identifier

(codeListId attribute)

the value "P.CLS.019" is specified

1

3. Position code

(hcsdo:PositionCode)

job code from the job classifier, if such classifier is included in the Union's register of normative and reference information

0..1
 

a) identifier of directory (classifier)

(attribute codeListId)

The code of the job classifier of employees shall be indicated in case such classifier is included in the Union's register of normative and reference information

1

4. Name of position

(csdo:PositionName)

if the requisite "3. Position code" is not filled in, the name of the position shall be indicated in the form of a normalized string not exceeding 120 characters in length

0..1

5. Contact details

(ccdo:CommunicationDetails)

composition of requisites and rules of their filling are given in Table 5

0..*

Table 8


Requirements for forming XML documents

according to the structure of the document in electronic form

"Information about the application to conduct registration of medical

products within the Eurasian Economic Union" (R.018)

N n/a

Element designation

Description

1

2

3

1

Code of the structure of electronic documents (information) used for XML-document formation in the register of structures of electronic documents and information

R.018

2

Used version of the structure of electronic documents (information)

1.1.0

3

Root element of an XML document

MedicalProductApplicationDetails

4

XML document namespace identifier

urn:EEC:R:MedicalProductApplicationDetails:v1.1.0

5

XML schema file name

EEC_R_MedicalProductApplicationDetails_v1.1.0.xsd

6

Imported namespaces

the list of imported namespaces is given in Table 9. Symbols “X.X.X.X” in the imported namespaces correspond to the version numbers of the base data model and data model of the subject area, used in the development of schemes of the structure of the electronic document (information) in accordance with paragraph 2 of the Decision of the Board of the Commission of June 30, 2017 N 78

Table 9


Imported namespaces

N n/a

Namespace identifier

Prefix

1

2

3

1

urn:EEC:M:ComplexDataObjects:vX.X.X

ccdo

2

urn:EEC:M:HC:ComplexDataObjects:vX.X.X

hccdo

3

urn:EEC:M:HC:SimpleDataObjects:vX.X.X

hcsdo

4

urn:EEC:M:SimpleDataObjects:vX.X.X

csdo

III. Requirements to the structure of the document in electronic form

"Information on the documents of the registration dossier of medical

of the product or documents executed in the course of the review

medical device registration file" (R.020)


15. The composition of requisites and general requirements for filling in the requisites of the structure of the document in electronic form "Information on the documents of the registration dossier of a medical device or documents executed during the review of the registration dossier of a medical device" (R.020) are given in Table 10.
16. When submitting electronically the documents of the registration dossier for which no structure requirements are defined, the *.pdf file included in the structure must contain a text layer.
17. Requirements for the formation of XML-document in accordance with the structure of the document in electronic form "Information on the documents of the registration dossier of a medical device or documents executed during the review of the registration dossier of a medical device" (R.020) are given in Table 11.

Table 10


Description of the composition of details of the document structure

in electronic form "Information on registration documents

medical device dossier or documents issued by the

when reviewing the registration file of a medical

products" (R.020)

Name of requisite

Rule of filling in the requisite

Mn.

1. Code of electronic document (information)

(csdo:EDocCode)

"R.020" is indicated

1

2. Identifier of the electronic document (information)

(csdo:EDocId)

universal unique identifier - a normalized character string 36 characters long, uniquely identifying an electronic document

1

3. Identifier of the original electronic document (information)

(csdo:EDocRefId)

identifier of the electronic document (information), in response to which this electronic document was generated

0..1

4. Date and time of the electronic document (information) (csdo:EDocDateTime)

date and time of creation of the electronic document in the format YYYYY-MM-DDThh:mm:ssZ

1

5. Country code

(csdo:UnifiedCountryCode)

the two-letter code of the country sending the document from the world country classifier according to ISO 3166-1 is indicated

1

 

(a) Directory (classifier) identifier (codeListId attribute)

the value "P.CLS.019" is specified

1

6. Number of the application for registration or other procedures related to the registration of the medical device

(hcsdo:MedicalProductApplicationId)

application number assigned by the authorized body of the reference state in the form of a normalized string of no more than 20 characters in length

0..1

7. Registration certificate number

(hcsdo:RegistrationCertificateId)

number of the registration certificate in the form of a normalized string of not more than 50 characters in length

0..1

8. Information about the document executed during the review of the medical product registration dossier or the document contained in the medical product registration dossier (hccdo:MedicalProductRegistrationDossierDetails)

information on the document drawn up during review of the registration dossier for the medical device, or the document contained in the registration dossier for the medical device. The requisite consists of the values of the nested requisites specified in clauses 8.1 - 8.11 of this table

1..*

 

8.1 Indication that the document belongs to the registration dossier for a medical device (hcsdo:MedicalRegistrationFileIndicator)

an attribute that identifies a document as belonging to the registration dossier:

1 is a document of the registration dossier;

0 - document to be issued during the examination of the registration dossier

0..1

 

8.2 Document number (csdo:DocId)

the number of the document of the registration dossier or the document drawn up during the examination of the registration dossier in the form of a normalized string of not more than 50 characters in length

0..1

 

8.3 Name of document

(csdo:DocName)

The name of the document of the registration dossier or the document drawn up during the examination of the registration dossier is indicated in the form of a normalized string of not more than 500 characters in length

0..1

 

8.4 Code of the type of document contained in the registration dossier for the medical device (hcsdo:MedicalProductRegistrationDocCode)

code of the type of document type of the registration dossier for the medical device in accordance with the classifier of types of documents of the registration dossier of the medical device, approved by the decision of the Board of the Commission dated April 3, 2018 N 48

0..1

 

 

(a) Directory (classifier) identifier

the value "2048" is specified

1

 

8.5 Name of the type of document contained in the registration dossier for the medical device (hcsdo:MedicalProductRegistrationDocName)

if requisite "8.4 Code of the type of document of the registration dossier for the medical device" is not filled in, the name of the type of document of the registration dossier for the medical device shall be indicated in the form of a normalized string not more than 500 characters long

0..1

 

8.6 Code of the type of document executed during the review of the registration dossier for the medical device (hcsdo:MedicalProductRegistrationFileCode)

code of the type of document type of the registration dossier for the medical device in accordance with the classifier of types of documents to be executed during the review of the registration dossier, approved by the decision of the Board of the Commission dated August 21, 2018 N 135

0..1

 

(a) Directory (classifier) identifier

the value "2043" is specified

1

 

8.7 Name of the type of document executed during the review of the registration dossier for the medical device (hcsdo:MedicalProductRegistrationFileName)

if the requisite "8.6 Code of the type of document drawn up during the review of the registration dossier for the medical device" is not filled in, the name of the type of document drawn up during the review of the registration dossier for the medical device shall be indicated in the form of a normalized string of not more than 500 characters in length.

0..1

 

8.8 Document Date (csdo:DocCreationDate)

the date of issuance of the document of the registration dossier or the document issued during the examination of the registration dossier, in the format YYYYY-MM-DD

1

 

8.9 Document expiration date (csdo:DocValidityDate)

the date of expiry of the registration dossier document or the document issued during the examination of the registration dossier, in the format YYYYY-MM-DD

0..1

 

8.10. Name of the business entity (csdo:BusinessEntityName)

the name of the organization that issued the document of the registration dossier or the document issued during the examination of the registration dossier in the form of a normalized string of not more than 300 characters in length

0..1

 

8.11. Description of the element of the document of the registration dossier or the document issued during consideration of the registration dossier (hcsdo:MedicalAttributeEnumText)

a description of an additional attribute of the document of the registration dossier or of the document drawn up during examination of the registration dossier in the form of a normalized string of not more than 4,000 characters in length

0..*

 

(a) Type code of the document element

(attribute MedicalAttributeKindEnumCode)

code designation of the type of additional attribute of the document of the registration dossier or of the document drawn up during examination of the registration dossier, in accordance with the list of possible values:

01 is the deadline for responding to the request;

02 is the document number of the foundation document;

03 is the type of the record file document for which the request is being made;

04 - type of document produced during the examination of the registration dossier in respect of which the request is made;

05 - path to the file in the file structure;

06 - name of the file to be replaced;

99 - other

0..1

 

b) name of the document element type (AttributeKindName attribute)

If the requisite "a) code of the type of document element" is not filled in, the name of the type of additional attribute of the document of the registration dossier or of the document drawn up during the examination of the registration dossier shall be indicated in the form of a normalized string of not more than 500 characters.

0..1

 

8.12. Document in binary format

(hcsdo:DocCopyBinaryText)

the document of the registration dossier or the document drawn up during the examination of the registration dossier in the form of a pdf file, for which no requirements to the electronic form are defined, in the form of a sequence of binary octets (bytes). It is obligatory to be filled in, if the requisite "8.13. XML-document" is not filled in

0..1

 

(a) Data format code (mediaTypeCode attribute)

the code designation of the type of data format "pdf" shall be indicated

0..1

 

8.13. XML document (ccdo:AnyDetails)

indicates the document of the registration dossier or the document drawn up during the examination of the registration dossier in XML format, for which requirements for electronic form are defined, in the form of a sequence of binary octets (bytes).

It is obligatory to be filled in if the requisite "8.12. Document in binary format" is not filled in

0..1

 

8.13.1. XML document

XML document of arbitrary structure is specified

1..*

9. Note

(csdo:NoteText)

additional explanatory text in the form of a normalized string not exceeding 4000 characters in length shall be indicated

0..1

Table 11


Requirements for XML document formation

according to the structure of the document in electronic form

"Information on the documents of the registration dossier of medical

of the product or documents executed in the course of the review

medical device registration file" (R.020)

N n/a

Element designation

Description

1

2

3

1

Code of the structure of electronic documents (information) used for XML-document formation in the register of structures of electronic documents and information

R.020

2

Used version of the structure of electronic documents (information)

1.1.0

3

Root element of an XML document

MedicalProductRegistrationDocumentDetails

4

XML document namespace identifier

urn:EEC:R:MedicalProductRegistrationDocumentDetails:v1.1.0

5

XML schema file name

EEC_R_MedicalProductRegistrationDocumentDetails_v1.1.0.xsd

6

Imported namespaces

The list of imported namespaces is given in Table 12.

Symbols “X.X.X.X” in imported namespaces correspond to the version numbers of the base data model and subject area data model used in the development of schemas of the structure of the electronic document (information) in accordance with paragraph 2 of the Decision of the Board of the Commission of June 30, 2017 No. 78

Table 12


Imported namespaces

N n/a

Namespace identifier

Prefix

1

2

3

1

urn:EEC:M:ComplexDataObjects:vX.X.X

ccdo

2

urn:EEC:M:HC:ComplexDataObjects:vX.X.X

hccdo

3

urn:EEC:M:HC:SimpleDataObjects:vX.X.X

hcsdo

4

urn:EEC:M:SimpleDataObjects:vX.X.X

csdo
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